Evidence review for the clinical and cost effectiveness of electrotherapy for the management of osteoarthritis

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Evidence review for the clinical and cost effectiveness of electrotherapy for the management of osteoarthritis

Osteoarthritis in over 16s: diagnosis and management

Evidence review G

NICE Guideline, No. 226

London: National Institute for Health and Care Excellence (NICE); 2022 Oct.

ISBN-13: 978-1-4731-4740-9

1. Electrotherapy for people with osteoarthritis

1.1. Review question

What is the clinical and cost-effectiveness of electrotherapy for the management of osteoarthritis?

1.1.1. Introduction

Electrotherapy can be used to provide pain relief in a range of conditions including osteoarthritis. Although Transcutaneous Electrical Nerve Stimulation (TENS) was recommended as an intervention to consider in NICE Osteoarthritis guideline CG177 it is not thought to be widely used within the NHS. TENS is available over the counter, however, so may be recommended by NHS healthcare professionals. Reviewing and updating the evidence again may help determine whether electrotherapy should be recommended as part of NHS treatment.

This review aims to evaluate the effectiveness of electrotherapeutic interventions (including pulsed short-wave therapy, interferential therapy, laser, transcutaneous electrical nerve stimulation, and ultrasound) in the management of osteoarthritis in adults.

1.1.2. Summary of the protocol

Table 1

PICO characteristics of review question.

For full details see the review protocol in Appendix A.

1.1.3. Methods and process

This evidence review was developed using the methods and process described in Developing NICE guidelines: the manual. Methods specific to this review question are described in the review protocol in Appendix A and the methods document.

Declarations of interest were recorded according to NICE’s conflicts of interest policy.

1.1.4. Effectiveness evidence

1.1.4.1. Included studies

Eighty-one randomised controlled trial studies (eighty-five papers) were included in the review;⁶^, ⁸^, ¹⁰^–¹³^, ¹⁵^–¹⁷^, ²¹^, ²²^, ²⁷^, ²⁹^, ³⁵^–³⁸^, ⁴⁰^–⁴²^, ⁴⁴^, ⁵⁸^, ⁶⁴^, ⁶⁶^, ⁶⁹^, ⁷¹^, ⁷⁴^, ⁷⁶^, ⁷⁹^, ⁸⁰^, ⁸³^, ⁸⁴^, ⁸⁶^, ⁹⁰^–⁹³^, ⁹⁶^, ⁹⁷^, ¹⁰⁰^–¹⁰²^, ¹⁰⁷^, ¹¹⁵^, ¹¹⁸^, ¹²⁰^, ¹²¹^, ¹²⁴^, ¹²⁶^, ¹³¹^, ¹³²^, ¹⁴²^, ¹⁴⁶^, ¹⁴⁸^, ¹⁵⁰^–¹⁵⁵^, ¹⁶⁰^, ¹⁶⁶^–¹⁷⁰^, ¹⁷⁵^, ¹⁷⁸^, ¹⁷⁹^, ¹⁹⁰^, ¹⁹³^, ²⁰⁵^, ²⁰⁸^, ²¹¹^, ²¹³^, ²¹⁷^, ²²⁰^, ²²⁴^, ²²⁵^, ²²⁹^, ²³⁶^–²³⁸^, ²⁴⁰ these are summarised in Table 2 below. Evidence from these studies is summarised in the clinical evidence summary below (Table 3).

The clinical studies identified included the following comparisons:

Pulsed short-wave therapy compared to sham electrotherapy²²^, ²⁷^, ⁴¹^, ⁶⁶^, ⁷⁹^, ⁸³^, ⁸⁶^, ¹⁵⁵^, ¹⁶⁰^, ¹⁶⁸^, ¹⁷⁹^, ²⁰⁸^, ²¹¹^, ²²⁰^, ²⁴⁰
Pulsed short-wave therapy compared to no treatment⁶^, ⁴⁴^, ⁶⁶^, ⁸³^, ¹⁵⁵
Pulsed short-wave therapy compared to laser therapy⁶⁶
Interferential therapy compared to pulsed short-wave therapy²²^, ⁶⁶
Interferential compared to laser therapy¹⁵^, ⁶⁶
Interferential therapy compared to sham electrotherapy¹⁵^, ²²^, ⁶⁶^, ⁹¹
Interferential therapy compared to no treatment⁶⁶
Neuromuscular electrical stimulation compared to no treatment²¹^, ³⁶^, ⁷⁶^, ¹³¹^, ¹⁵⁴^, ¹⁷⁰
Extracorporeal shockwave therapy compared to sham electrotherapy⁵⁸^, ²¹⁷^, ²³⁶^–²³⁸
Extracorporeal therapy compared to no treatment⁷⁴^, ⁹⁰
Laser therapy compared to neuromuscular electrical stimulation¹⁵²
Laser therapy compared to sham electrotherapy¹⁰^, ¹³^, ¹⁵^, ²⁹^, ³⁵^, ³⁷^, ⁴²^, ⁶⁶^, ⁸⁴^, ⁹²^, ⁹³^, ⁹⁶^, ⁹⁷^, ¹⁰⁰^, ¹²⁰^, ¹⁴⁶^, ¹⁴⁸^, ¹⁵⁰^, ¹⁹³^, ²²⁹
Laser therapy compared to no treatment⁸^, ⁶⁴^, ⁶⁶^, ⁹⁷
Transcutaneous electrical nerve stimulation compared to pulsed short-wave therapy²²^, ⁴⁴
Transcutaneous electrical nerve stimulation compared to interferential therapy²²^, ³⁸
Transcutaneous electrical nerve stimulation compared to sham electrotherapy¹⁷^, ²²^, ¹⁰⁷^, ¹³²^, ¹⁶⁹^, ¹⁷⁵^, ¹⁷⁸
Transcutaneous electrical nerve stimulation compared to no treatment⁴⁴^, ¹⁵¹^, ¹⁷⁵^, ¹⁷⁸
Ultrasound compared to pulsed short-wave therapy⁴⁴
Ultrasound compared to neuromuscular electrical stimulation⁶⁹
Ultrasound compared to transcutaneous electrical nerve stimulation⁴⁴^, ¹⁵¹
Ultrasound compared to sham electrotherapy⁴⁰^, ⁷¹^, ¹¹⁵^, ¹¹⁸^, ¹²⁴^, ¹²⁶^, ¹⁴²^, ¹⁶⁶^, ¹⁶⁷^, ²⁰⁵^, ²¹³^, ²²⁴^, ²²⁵
Ultrasound compared to no treatment¹²^, ⁴⁴^, ¹⁰¹^, ¹⁰²^, ¹⁵¹
Combination therapy compared to neuromuscular electrical stimulation¹⁵²
Combination therapy compared to laser therapy¹⁵^, ¹⁵²
Combination therapy compared to ultrasound¹²⁴^, ¹⁹⁰
Combination compared to interferential therapy¹⁵
Combination therapy compared to sham electrotherapy¹⁵^, ¹²⁴
Combination therapy compared to transcutaneous electrical nerve stimulation¹²¹
Combination therapy compared to no treatment¹⁶^, ⁷⁴

Evidence was available for each intervention stated in the protocol. However, there was no evidence for the following comparison to sham electrotherapy:

Neuromuscular electrical stimulation

See also the study selection flow chart in Appendix C, study evidence tables in Appendix D, forest plots in Appendix E and GRADE tables in Appendix F.

A network meta-analysis was not conducted for this review. This was due to the heterogeneity identified in the studies and outcomes, including heterogeneity in the types of interventions (including the intensity of therapy delivered) and in comparisons (different types of sham therapy devices, some studies delivering different levels of concomitant care being combined in the no treatment group). Given this, the committee agreed it would be difficult to draw conclusions from the results of a network meta-analysis and so used the evidence from pairwise meta-analysis instead.

1.1.4.1.1. Combination therapy

The combinations of therapy reported in the studies included:

Laser therapy combined with neuromuscular electrical stimulation¹⁵²
Ultrasound combined with transcutaneous electrical nerve stimulation¹⁶^, ⁷⁴^, ¹²¹^, ¹²⁴^, ¹⁹⁰,
Interferential combined with laser therapy¹⁵

No other combinations were reported.

1.1.4.1.2. Inconsistency

Heterogeneity was seen in outcomes in the following comparisons:

Pulsed short-wave therapy compared to sham electrotherapy (quality of life, pain and physical function)
Interferential therapy compared to sham electrotherapy (pain and physical function)
Neuromuscular electrical stimulation compared to no treatment (physical function)
Laser therapy compared to sham electrotherapy (pain and physical function)
Laser therapy compared to no treatment (quality of life, pain and physical function)
Transcutaneous electrical nerve stimulation compared to interferential therapy (pain and physical function)
Transcutaneous electrical nerve stimulation compared to sham electrotherapy (pain and physical function)
Transcutaneous electrical nerve stimulation compared to no treatment (pain and physical function)

In these scenarios, there was either an insufficient number of studies to form valid subgroups or subgroup analysis did not resolve the heterogeneity, therefore outcomes were downgraded for inconsistency and analysed using a random effects model.

1.1.4.1.3. Indirectness

The majority of evidence was direct in most cases and therefore only one outcome was downgraded for indirectness. However, some outcomes included indirect components.

Cho 2016⁵⁸ included people with osteoarthritis who had also had a stroke and so was noted as having serious population indirectness.
Marquina 2012¹⁵⁰ did not define the population as having knee osteoarthritis, but included people with chronic knee pain so was noted as having serious population indirectness.
Thamsborg 2005²⁰⁸ included a sham intervention that sounded like it could have an active effect (a device applying a magnetic field with a DC current rather than a pulse generating therapy) and so was noted as having serious intervention indirectness.

1.1.4.2. Excluded studies

Cochrane reviews were identified but could not be included due to using interventions not stated in the protocol (Rutjes 2010¹⁸⁸, Zammit 2010²³¹), using comparisons not stated in the protocol and different outcome measures being used (Li 2013¹³⁸, Osiri 2000¹⁶⁴). The references were checked any studies that fulfilled the inclusion criteria were included.

See the excluded studies list in Appendix J.

1.1.5. Summary of studies included in the effectiveness evidence

1.1.5.1. Pulsed short-wave therapy compared to sham electrotherapy

Table 2

Summary of studies included in the pulsed short-wave therapy compared to sham electrotherapy comparison.

1.1.5.2. Pulsed short-wave therapy compared to no treatment

Table 3

Summary of studies included in the pulsed short-wave therapy compared to no treatment comparison.

1.1.5.3. Interferential therapy compared to pulsed short-wave therapy

Table 4

Summary of studies included in the interferential therapy compared to pulsed short-wave therapy comparison.

1.1.5.4. Interferential therapy compared to laser therapy

Table 5

Summary of studies included in the interferential therapy compared to laser therapy comparison.

1.1.5.5. Interferential therapy compared to sham electrotherapy

Table 6

Summary of studies included in the interferential therapy compared to sham electrotherapy comparison.

1.1.5.6. Interferential therapy compared to no treatment

Table 7

Summary of studies included in the interferential therapy compared to no treatment comparison.

1.1.5.7. Neuromuscular electrical stimulation compared to no treatment

Table 8

Summary of studies included in the neuromuscular electrical stimulation compared to no treatment comparison.

1.1.5.8. Extracorporeal shockwave therapy compared to sham electrotherapy

Table 9

Summary of studies included in the extracorporeal shockwave therapy compared to sham electrotherapy comparison.

1.1.5.9. Extracorporeal shockwave therapy compared to no treatment

Table 10

Summary of studies included in the extracorporeal shockwave therapy compared to no treatment comparison.

1.1.5.10. Laser therapy compared to pulsed short-wave therapy

Table 11

Summary of studies included in the pulsed short-wave therapy compared to laser therapy comparison.

1.1.5.11. Laser therapy compared to neuromuscular electrical stimulation

Table 12

Summary of studies included in the laser therapy compared to neuromuscular electrical stimulation comparison.

1.1.5.12. Laser therapy compared to sham electrotherapy

Table 13

Summary of studies included in the laser therapy compared to sham electrotherapy comparison.

1.1.5.13. Laser therapy compared to no treatment

Table 14

Summary of studies included in the laser therapy compared to no treatment comparison.

1.1.5.14. Transcutaneous electrical nerve stimulation compared to pulsed short-wave therapy

Table 15

Summary of studies included in the transcutaneous electrical nerve stimulation compared to pulsed short-wave therapy comparison.

1.1.5.15. Transcutaneous electrical nerve stimulation compared to interferential therapy

Table 16

Summary of studies included in the transcutaneous electrical nerve stimulation compared to interferential therapy comparison.

1.1.5.16. Transcutaneous electrical nerve stimulation compared to sham electrotherapy

Table 17

Summary of studies included in transcutaneous electrical nerve stimulation compared to sham electrotherapy comparison.

1.1.5.17. Transcutaneous electrical nerve stimulation compared to no treatment

Table 18

Summary of studies included in the transcutaneous electrical nerve stimulation compared to no treatment comparison.

1.1.5.18. Ultrasound compared to pulsed short-wave therapy

Table 19

Summary of studies included in the ultrasound compared to pulsed short-wave therapy comparison.

1.1.5.19. Ultrasound compared to neuromuscular electrical stimulation

Table 20

Summary of studies included in the ultrasound compared to neuromuscular electrical stimulation.

1.1.5.20. Ultrasound compared to transcutaneous electrical nerve stimulation

Table 21

Summary of studies included in the ultrasound compared to transcutaneous electrical nerve stimulation.

1.1.5.21. Ultrasound compared to sham electrotherapy

Table 22

Summary of studies included in the ultrasound compared to sham electrotherapy comparison.

1.1.5.22. Ultrasound compared to no treatment

Table 23

Summary of studies included in the ultrasound compared to no treatment comparison.

1.1.5.23. Combination therapy compared to interferential therapy

Table 24

Summary of studies included in the combination therapy compared to interferential therapy comparison.

1.1.5.24. Combination therapy compared to neuromuscular electrical stimulation

Table 25

Summary of studies included in the combination therapy compared to neuromuscular electrical stimulation comparison.

1.1.5.25. Combination therapy compared to laser therapy

Table 26

Summary of studies included in the combination therapy compared to laser therapy comparison.

1.1.5.26. Combination therapy compared to transcutaneous electrical nerve stimulation

Table 27

Summary of studies included in the combination therapy compared to transcutaneous electrical nerve stimulation comparison.

1.1.5.27. Combination therapy compared to ultrasound

Table 28

Summary of studies included in the combination therapy compared to ultrasound comparison.

1.1.5.28. Combination therapy compared to sham treatment

Table 29

Summary of studies included in the combination therapy compared to sham treatment comparison.

1.1.5.29. Combination therapy compared to no treatment

Table 30

Summary of studies included in the combination therapy compared to no treatment comparison.

1.1.5.30. Matrices

Table 31

Summary matrix for all interventions at ≤3 months.

Table 32

Summary matrix for all interventions at >3 months.

1.1.6. Summary of the effectiveness evidence

1.1.6.1. Pulsed short-wave therapy compared to sham electrotherapy and no treatment

Table 33

Clinical evidence summary: pulsed short-wave therapy compared to sham electrotherapy.

Table 34

Clinical evidence summary: pulsed short-wave therapy compared to no treatment.

1.1.6.2. Interferential therapy compared to pulsed short-wave therapy, laser therapy, sham electrotherapy and no treatment

Table 35

Clinical evidence summary: interferential therapy compared to pulsed short-wave therapy.

Table 36

Clinical evidence summary: interferential therapy compared to laser therapy.

Table 37

Clinical evidence summary: interferential therapy compared to sham electrotherapy.

Table 38

Clinical evidence summary: interferential therapy compared to no treatment.

1.1.6.3. Neuromuscular electrical stimulation compared to no treatment

Table 39

Clinical evidence summary: neuromuscular electrical stimulation compared to no treatment.

1.1.6.4. Extracorporeal shockwave therapy compared to sham electrotherapy and no treatment

Table 40

Clinical evidence summary: extracorporeal shockwave therapy compared to sham electrotherapy.

Table 41

Clinical evidence summary: extracorporeal shockwave therapy compared to no treatment.

1.1.6.5. Laser therapy compared to pulsed short-wave therapy, neuromuscular electrical stimulation, sham electrotherapy and no treatment

Table 42

Clinical evidence summary: laser therapy compared to pulsed short-wave therapy.

Table 43

Clinical evidence summary: laser therapy compared to neuromuscular electrical stimulation.

Table 44

Clinical evidence summary: laser therapy compared to sham electrotherapy.

Table 45

Clinical evidence summary: laser therapy compared to no treatment.

1.1.6.6. Transcutaneous electrical nerve stimulation compared to pulsed short-wave therapy, interferential therapy, sham electrotherapy and no treatment

Table 46

Clinical evidence summary: transcutaneous electrical nerve stimulation compared to pulsed short-wave therapy.

Table 47

Clinical evidence summary: transcutaneous electrical nerve stimulation compared to interferential therapy.

Table 48

Clinical evidence summary: transcutaneous electrical nerve stimulation compared to sham electrotherapy.

Table 49

Clinical evidence summary: transcutaneous electrical nerve stimulation compared to no treatment.

1.1.6.7. Ultrasound compared to pulsed short-wave therapy, neuromuscular electrical stimulation, transcutaneous electrical nerve stimulation, sham ultrasound and no treatment

Table 50

Clinical evidence summary: ultrasound compared to pulsed short-wave therapy.

Table 51

Clinical evidence summary: ultrasound compared to neuromuscular electrical stimulation.

Table 52

Clinical evidence summary: ultrasound compared to transcutaneous electrical nerve stimulation.

Table 53

Clinical evidence summary: ultrasound compared to sham electrotherapy.

Table 54

Clinical evidence summary: ultrasound compared to no treatment.

1.1.6.8. Combination therapy compared to interferential therapy, neuromuscular electrical stimulation, laser therapy, transcutaneous electrical nerve stimulation, ultrasound, sham electrotherapy and no treatment

Table 55

Clinical evidence summary: combination therapy compared to interferential therapy.

Table 56

Clinical evidence summary: combination therapy compared to neuromuscular electrical stimulation.

Table 57

Clinical evidence summary: combination therapy compared to laser therapy.

Table 58

Clinical evidence summary: combination therapy compared to transcutaneous electrical nerve stimulation.

Table 59

Clinical evidence summary: combination therapy compared to ultrasound.

Table 60

Clinical evidence summary: combination therapy compared to sham electrotherapy.

Table 61

Clinical evidence summary: combination therapy compared to no treatment.

See Appendix F for full GRADE tables.

1.1.7. Economic evidence

1.1.7.1. Included studies

One health economic study with the relevant comparison was included in this review.¹⁴⁵ This is summarised in the health economic evidence profile below (62) and the health economic evidence table in Appendix H.

1.1.7.2. Excluded studies

No relevant health economic studies were excluded due to limited applicability or methodological limitations.

See also the health economic study selection flow chart in Appendix G.

1.1.8. Summary of included economic evidence

Table 62

Health economic evidence profile: Electrotherapy versus usual care.

1.1.9. Economic model

This area was not prioritised for new cost-effectiveness analysis.

1.1.10. Unit costs

Relevant unit costs are provided below to aid consideration of cost effectiveness.

Resource	Average unit cost	Source
Community physiotherapist (band 5/6/7)	£38/£50/£60^(a)	PSSRU 2020⁶¹

(a): Per hour, including qualification costs

1.1.11. Economic evidence statements

One cost-utility analysis compared usual care to a multitude of electrotherapy options; interferential therapy, laser light therapy, neuromuscular electrical stimulation (NMES), pulsed electromagnetic field (PEMF), pulsed electrical stimulation (PES) and transcutaneous electrical nerve stimulation (TENS) as well as non-electrotherapy options; acupuncture, braces, heat treatment insoles and static magnets. TENS was the only electrotherapy option that was cost effective compared with usual care with a cost per QALY gained of £2,690. This analysis was assessed as directly applicable with potentially serious limitations.

1.1.12. The committee’s discussion and interpretation of the evidence

1.1.12.1. The outcomes that matter most

The critical outcomes were quality of life, pain and physical function. These were considered critical due to their importance to people with osteoarthritis. The Osteoarthritis Research Society International (OARSI) consider that pain and physical function were the most important outcomes for evaluating interventions. Quality of life gives a broader perspective on the person’s wellbeing, allowing for examination of the biopsychosocial impact of interventions. Psychological distress, osteoarthritis flare, mild adverse events and moderate/major adverse events were included as important outcomes.

The committee considered osteoarthritis flares to be important in the lived experience and management of osteoarthritis. However, these were also considered difficult to measure with no clear consensus on their definition. The Flares in OA OMERACT working group have proposed an initial definition and domains of OA flares through a consensus exercise; “it is a transient state, different from the usual state of the condition, with a duration of a few days, characterized by onset, worsening of pain, swelling, stiffness, impact on sleep, activity, functioning, and psychological aspects that can resolve spontaneously or lead to a need to adjust therapy”. However, this has been considered to have limitations and has not been widely adopted. Therefore, the committee included the outcome accepting any reasonable definition provided by any studies discussing the event.

Mortality was included as a treatment adverse event rather than as a discreet outcome and categorised as an important outcome. Osteoarthritis as a disease process is not considered to cause mortality by itself and mortality is an uncommon outcome from osteoarthritis interventions.

There was evidence available for all outcomes apart from osteoarthritis flares. However, there was only limited evidence available regarding psychological distress and adverse events.

1.1.12.2. The quality of the evidence

Sixty-six randomised controlled trial studies were included in the review. The comparisons where evidence was present included:

Pulsed short-wave therapy compared to sham electrotherapy
Pulsed short-wave therapy compared to no treatment
Interferential therapy compared to pulsed short-wave therapy
Interferential therapy compared to laser therapy
Interferential therapy compared to sham electrotherapy
Interferential therapy compared to no treatment
Neuromuscular electrical stimulation compared to no treatment
Extracorporeal shockwave therapy compared to sham electrotherapy
Extracorporeal shockwave therapy compared to no treatment
Laser therapy compared to pulsed short-wave therapy
Laser therapy compared to neuromuscular electrical stimulation
Laser therapy compared to sham electrotherapy
Laser therapy compared to no treatment
Transcutaneous electrical nerve stimulation compared to pulsed short-wave therapy
Transcutaneous electrical nerve stimulation compared to interferential therapy
Transcutaneous electrical nerve stimulation compared to sham electrotherapy
Transcutaneous electrical nerve stimulation compared to no treatment
Ultrasound compared to pulsed short-wave therapy
Ultrasound compared to neuromuscular electrical stimulation
Ultrasound compared to transcutaneous electrical nerve stimulation
Ultrasound compared to sham electrotherapy
Ultrasound compared to no treatment
Combination therapy compared to interferential therapy
Combination therapy compared to neuromuscular electrical stimulation
Combination therapy compared to laser therapy
Combination therapy compared to transcutaneous electrical nerve stimulation
Combination therapy compared to ultrasound
Combination therapy compared to sham electrotherapy
Combination therapy compared to no treatment

The evidence varied from high to very low quality, with the majority being of low quality. Outcomes were commonly downgraded for risk of bias, in particular for selection bias and performance bias (apart from where the comparator was sham therapy), and imprecision. Some outcomes were downgraded for inconsistency. When present, inconsistent results were not explained by subgroup analysis. The majority of comparisons consisted of studies with a small number of participants (less than 50) with a few studies that included a larger number of participants.

The committee agreed that there was some evidence comparing the majority of different forms of electrotherapy to sham or no treatment (with the exception of neuromuscular electrical stimulation that was not compared to sham electrotherapy). However, findings were often mixed and there is insufficient evidence to compare different types of electrotherapy to each other.

Pulsed short-wave therapy

When compared to interferential therapy, the evidence was based on 2 studies and was of moderate to low quality due to risk of bias and imprecision.
When compared to laser therapy, the evidence was based on 1 small study (N=40 for this comparison) reporting 2 outcomes that were of moderate and low quality respectively due to risk of bias and imprecision.
When compared to transcutaneous electrical nerve stimulation, the evidence was based on 2 studies and was of low quality due to risk of bias and imprecision.
When compared to ultrasound, the evidence was based on 1 small study (N=40) reporting 1 outcome that was of very low quality, due to risk of bias and imprecision.
When compared to sham electrotherapy, the evidence was based on 15 studies and the quality of the outcomes was between high and very low quality, with the majority of evidence being of moderate-low quality. Outcomes were often downgraded due to risk of bias and imprecision. However, some outcomes were downgraded due to inconsistency (including some pain and physical function outcomes).
When compared to no treatment, the evidence was based on 5 studies. Most outcomes included only 1 small study and were of moderate-very low quality, with the majority being of very low quality. Outcomes were often downgraded due to risk of bias and imprecision.

Interferential therapy

When compared to interferential therapy, the evidence was based on 2 studies and the outcomes were of moderate to low quality due to risk of bias and imprecision.
When compared to laser therapy, the evidence was based on 2 studies and the quality of the outcomes was between moderate and low quality. Outcomes were often downgraded for risk of bias and imprecision.
When compared to transcutaneous electrical nerve stimulation, the evidence was based on 2 studies with only 1 study reporting each outcome and was of low quality due to risk of bias and imprecision.
When compared to combination therapy (interferential therapy and laser therapy), the evidence was based on 1 small study (N=84 for this comparison) with the outcomes being of moderate quality due to imprecision.
When compared to sham electrotherapy, the evidence was based on 4 studies where outcomes ranged from moderate to very low quality. Outcomes were often downgraded for risk of bias and imprecision. However, some outcomes were downgraded for inconsistency, with heterogeneity that could not be resolved by subgroup analysis.
When compared to no treatment, the evidence was based on 1 small study (N=40) with outcomes ranging from moderate to low quality, due to concerns risk of bias and both risk of bias and imprecision respectively.

Neuromuscular electrical stimulation

Neuromuscular electrical stimulation was compared to laser therapy, ultrasound, combination therapy and no treatment. The majority of comparisons only had data reported at less than 3 months. The comparison to no treatment had data available at less than and more than 3 months.

When compared to laser therapy, 1 outcome was reported in 1 small study (N=30) that was of low quality due to risk of bias and imprecision.
When compared to ultrasound, outcomes were reported in 1 small study (N=60) that was of low quality due to risk of bias and imprecision.
When compared to combination therapy (laser therapy and neuromuscular electrical stimulation), 1 outcome was reported in 1 small study (N=29) that was of low quality due to risk of bias and imprecision.
When compared to no treatment, the evidence was based on 6 studies. The quality ranged from moderate to very low quality, with the majority being of very low quality. Studies were commonly downgraded due to risk of bias and imprecision. 1 outcome was downgraded due to inconsistency.

Extracorporeal shockwave therapy

Extracorporeal shockwave therapy was compared to sham electrotherapy and no treatment at ≤3 months only.

When compared to sham electrotherapy, the evidence was based on 5 studies. The outcomes ranged from moderate to very low quality due to risk of bias, imprecision and in some cases, inconsistency with heterogeneity that could not be resolved by subgroup analysis.
When compared to no treatment, the evidence was based on 2 studies. The outcomes were of low quality due to risk of bias and imprecision.

Laser therapy

When compared to pulsed short-wave therapy, the evidence was based on 1 small study (N=40 for this comparison) reporting 2 outcomes that were of moderate and low quality respectively due to risk of bias and imprecision.
When compared to interferential therapy, the evidence was based on 2 studies and the quality of the outcomes was between moderate and low quality. Outcomes were often downgraded for risk of bias and imprecision.
When compared to neuromuscular electrical stimulation, 1 outcome was reported in 1 small study (N=30) that was of low quality due to risk of bias and imprecision.
When compared to combination therapy (laser therapy and interferential therapy or laser therapy and neuromuscular electrical stimulation), 2 outcomes was reported in 2 studies that were of moderate and low quality due to risk of bias and imprecision respectively.
When compared to sham electrotherapy, the evidence was based on 20 studies. The quality ranged between high and very low quality, with the majority being of moderate to low quality. Studies were often downgraded due to risk of bias, inconsistency or imprecision. 6 outcomes were downgraded due to inconsistency.
When compared to no treatment, the evidence was based on 3 studies. The quality was of low or very low quality. Studies were often downgraded due to risk of bias and imprecision. 3 outcomes were downgraded due to inconsistency.

Transcutaneous electrical nerve stimulation

When compared to pulsed short-wave therapy, the evidence was based on 2 studies and was of low quality due to risk of bias and imprecision.
When compared to interferential therapy, the evidence was based on 2 studies with only 1 study reporting each outcome and was of low quality due to risk of bias and imprecision.
When compared to ultrasound, the evidence was based on 2 small studies with only 1 study reporting each outcome and was of very low quality due to risk of bias and imprecision.
When compared to combination therapy (transcutaneous electrical nerve stimulation and ultrasound), the evidence was based on 1 small study (N=40 for this comparison) with outcomes ranging between moderate and very low quality due to indirectness (using the global score of SF-36 for quality of life rather than the relevant subscales) and imprecision.
When compared to sham electrotherapy, the evidence was based on 6 studies. The quality of evidence ranged from moderate to very low quality, with the majority being of very low quality. Studies were often downgraded due to risk of bias and imprecision. 2 outcomes were downgraded due to inconsistency.
When compared to no treatment, the evidence was based on 4 studies. The evidence ranged between low and very low quality. Studies were often downgraded for risk of bias, inconsistency and imprecision. 2 outcomes were downgraded due to inconsistency.

Ultrasound

Ultrasound was compared to pulsed short-wave therapy, neuromuscular electrical stimulation, transcutaneous electrical nerve stimulation, combination therapy, sham electrotherapy and no treatment. Evidence was available for all comparisons at ≤3 months but only limited evidence was available at >3 months when compared to sham electrotherapy and no treatment.

When compared to pulsed short-wave therapy, the evidence was based on 1 small study (N=40) reporting 1 outcome that was of very low quality, due to risk of bias and imprecision.
When compared to neuromuscular electrical stimulation, outcomes were reported in 1 small study (N=60) that was of low quality due to risk of bias and imprecision.
When compared to transcutaneous electrical nerve stimulation, the evidence was based on 2 small studies with only 1 study reporting each outcome and was of very low quality due to risk of bias and imprecision.
When compared to combination therapy (transcutaneous electrical nerve stimulation and ultrasound), the evidence was based on 2 studies with the outcomes being of low to very low quality due to risk of bias, imprecision and inconsistency, due to some studies reporting mild adverse events including zero events while others report events in all study arms.
When compared to sham electrotherapy, the evidence was based on 11 studies. The quality of evidence ranged from high to very low quality, with the majority being of moderate to low quality. Studies were often downgraded for risk of bias and imprecision. 2 outcomes were downgraded due to inconsistency.
When compared to no treatment, the evidence was based on 4 studies. The quality of evidence ranged from low to very low quality, with the majority being of very low quality. Studies were often downgraded for risk of bias and imprecision. 3 outcomes were downgraded due to inconsistency.

Combination therapy

When compared to interferential therapy, the evidence was based on 1 small study (N=84 for this comparison) with the outcomes being of moderate quality due to imprecision.
When compared to neuromuscular electrical stimulation, 1 outcome was reported in 1 small study (N=29) that was of low quality due to risk of bias and imprecision.
When compared to laser therapy, 2 outcomes was reported in 2 studies that were of moderate and low quality due to risk of bias and imprecision respectively.
When compared to transcutaneous electrical nerve stimulation, the evidence was based on 1 small study (N=40 for this comparison) with outcomes ranging between moderate and very low quality due to indirectness (using the global score of SF-36 for quality of life rather than the relevant subscales) and imprecision.
When compared to ultrasound, the evidence was based on 2 studies with the outcomes being of low to very low quality due to risk of bias, imprecision and inconsistency, due to some studies reporting mild adverse events including zero events while others report events in all study arms.
When compared to sham electrotherapy, the evidence was based on 2 studies and ranged from high to low quality due to imprecision.
When compared to no treatment, the evidence was based on 2 studies and ranged from low to very low quality due to risk of bias, imprecision and inconsistency with heterogeneity that could be not resolved by subgroup analysis.

1.1.12.3. Benefits and harms

Key uncertainties

The committee discussed that generally the adverse events data for these trials was limited as this was generally found in small studies with a short follow up time and so it is unclear whether this is representative of the events expected to be seen in real life practice. Given this, the committee considered the evidence for mild, moderate and severe adverse events to be unclear throughout the review reflecting this in their weighting of findings while making recommendations. The committee noted throughout the evidence that the number of adverse events was often low and where events were reported they were transient in nature (such as increased pain). Given this, while the committee acknowledged where clinically important differences were highlighted in the evidence, but also considered the nature and true number of these events.

On examining the evidence, the committee agreed that there was significant heterogeneity in the interventions being offered between studies investigating the same class, which made it difficult to draw conclusions regarding the interventions. This variation was also present in the use of sham comparisons, where the techniques used to achieve this varied from using the device but having no power entering the machine, to using devices made to simulate the effect. In some cases, these shams seemed like they may not effectively blind the participant due to the vigorous nature of the intervention (such as for extracorporeal shockwave therapy). The committee acknowledge the challenges in examining these interventions using these methods and considered this when making recommendations.

Pulsed short-wave therapy

Pulsed short-wave therapy was compared to interferential therapy, laser therapy, transcutaneous electrical nerve stimulation, ultrasound, sham electrotherapy and no treatment. When compared to sham electrotherapy, unclear effects were seen in quality of life and pain at ≤3 months, where 1 outcome including 1 and9 studies respectively showed a clinically important benefit, while 2 outcomes including 4 studies for quality of life and 1 outcome including 4 studies for pain showed no clinically important difference. The clinically important benefit for pain was seen in an analysis where the result was inconsistent, with some studies showing clinically important benefits while others showed no difference. These unclear effects for pain were also seen at >3 months. Clinically important benefits were seen in physical function (based on low to very low quality evidence). No clinically important differences were seen in psychological distress, mild and moderate/major adverse events. When compared to no treatment, unclear effects were seen for quality of life (present at less than and more than 3 months), pain and physical function where some outcomes showed clinically important benefits while others showed no clinically important differences. When compared to other interventions, pulsed short-wave therapy had an unclear effect when compared to laser therapy (where laser therapy led to clinically important benefits in pain, while pulsed short-wave therapy led to clinically important benefits in physical function). Otherwise, there did not appear to be a clinically important difference between pulsed-short wave therapy and the other therapies mentioned above.

Interferential therapy

Interferential therapy was compared to pulsed short-wave therapy, laser therapy, transcutaneous electrical nerve stimulation, combination therapy, sham electrotherapy and no treatment. When compared to sham electrotherapy at ≤3 months, an unclear effect was seen for pain, with 1 outcome including 3 studies indicating a clinically important benefit based on very low quality evidence, while 1 outcome including 1 study indicated no clinically important difference based on moderate quality evidence. Clinically important benefits were seen for physical function based on two studies. When compared to other interventions, interferential therapy appeared to cause a clinically important benefit in mild adverse events when compared to transcutaneous electrical nerve stimulation. A clinically important difference in physical function was seen when compared to laser therapy based on evidence from 1 small study (N=40). No effects were sustained at >3 months.

Neuromuscular electrical stimulation

Neuromuscular electrical stimulation was compared to laser therapy, ultrasound, combination therapy and no treatment. When compared to no treatment at ≤3 months, unclear effects were seen in pain where 1 outcome showed a clinically important benefit with 1 outcome showed no clinically important difference. An unclear effect was seen in quality of life. However, in this case 6 outcomes indicated no clinically important difference while 2 outcomes indicated a clinically important harm. Otherwise, there was no clinically important difference seen in physical function and mild adverse events. However, at >3 months clinically important benefits were seen in pain and physical function. When compared to other interventions neuromuscular electrical stimulation appeared inferior. When compared to laser therapy there was a clinically important harm in pain based on 1 small study (N=30), and when compared to ultrasound there were clinically important harms in pain and physical function based on 1 small study (N=60). When compared to combination therapy there was no clinically important difference in pain based on 1 small study (N=29).

Extracorporeal shockwave therapy

Extracorporeal shockwave therapy was compared to sham electrotherapy and no treatment at ≤3 months only. When compared to sham electrotherapy clinically important benefits were seen in pain, physical function and mild adverse events, while no clinically important difference was seen in moderate/major adverse events. However, when compared to no treatment no clinically important difference was seen in pain while a clinically important harm was seen in physical function. The committee considered the studies and agreed that, while a sham comparison was used, it was unlikely to be sufficiently blinded due to the sensation that a person receiving extracorporeal shockwave therapy being of a likely greater amplitude to that received with sham. This meant that people may have known if they received the real or sham treatment, creating uncertainty in the effect. They also agreed that, while the overall number of participants in the meta-analysis was larger (N=307 and N=200 for pain and physical function respectively) the individual studies were still small. Given these factors and the uncertainty seen between the sham and no treatment comparisons, the committee agreed that there was currently insufficient evidence to support the use of extracorporeal shockwave therapy.

Laser therapy

Laser therapy was compared to pulsed short-wave therapy, interferential therapy, neuromuscular electrical stimulation, combination therapy, sham electrotherapy and no treatment. When compared to sham electrotherapy, a clinically important benefit was seen in moderate/major adverse events based on 1 small study (N=55). Unclear effects were seen in quality of life and pain with some outcomes showing a clinically important benefit while others showed no difference. For pain, 4 studies were included in the outcome showing a clinically important benefit while 14 were included in the outcome showing no clinically important difference. However, the outcomes showing a benefit were affected by inconsistency. No clinically important difference was seen in physical function and mild adverse events. When compared to no treatment, there was a clinically important benefit in physical function but no clinically important difference in quality of life and pain. For both comparisons, no effects were retained at >3 months.

When compared to other interventions, laser therapy had an unclear effect when compared to pulsed short-wave therapy (where laser therapy led to clinically important benefits in pain, while pulsed short-wave therapy led to clinically important benefits in physical function). Interferential therapy had a clinically important benefit in physical function when compared to laser therapy. Laser therapy had a clinically important benefit on pain when compared to neuromuscular electrical stimulation based on 1 small study (N=30). However, when compared to combination therapy, there was no clinically important difference in pain.

Transcutaneous electrical nerve stimulation

Transcutaneous electrical nerve stimulation was compared to pulsed short-wave therapy, interferential therapy, ultrasound, combination therapy, sham electrotherapy and no treatment. When compared to sham electrotherapy, there was an unclear effect on quality of life with 2 outcomes showing a clinically important benefit while 3 showed no clinically important difference. There was no clinically important difference in pain, physical function and mild adverse events. The effects on pain and physical function were both seen at less than and more than 3 months. When compared to no treatment there was no clinically important difference in pain, physical function and mild adverse events. When compared to other treatments, there was no clinically important difference in pain and physical function seen when compared to pulsed short-wave therapy and interferential therapy though there appeared to be a clinically important harm in mild adverse events when compared to interferential therapy. When compared to ultrasound, there was a mixed effect with 1 outcome including 1 small study (N=24) showing a clinically important benefit while 1 outcome including another 1 small study (N=40) showed no clinically important difference.

Ultrasound

Ultrasound was compared to pulsed short-wave therapy, neuromuscular electrical stimulation, transcutaneous electrical nerve stimulation, combination therapy, sham electrotherapy and no treatment. When compared to sham electrotherapy there was a clinically important benefit in pain (seen in 2 outcomes including 13 studies). This effect was not seen at greater than 3 months. However, these outcomes were affected by inconsistency. There was an unclear effect on quality of life with 5 outcomes showing a clinically important benefit and 5 outcomes showing no clinically important difference. There was no clinically important difference seen in physical function, psychological distress and mild adverse event. When compared to no treatment, there was no clinically important difference in quality of life and pain, but a clinically important harm seen in physical function based on 2 studies. When compared to other treatments, there were clinically important benefits in pain and physical function seen compared to neuromuscular electrical stimulation based on 1 small study (N=60). There was no clinically important difference in pain seen when compared to pulsed short-wave therapy, and no difference in pain and mild adverse events when compared to combination therapy. There was an unclear effect with no clinically important difference in pain in 1 outcome including 1 small study (N=40), and a clinically important harm in 1 outcome including 1 small study (N=24).

Combination therapy

Combination therapy was compared to interferential therapy, neuromuscular electrical stimulation, laser therapy, transcutaneous electrical nerve stimulation, ultrasound, sham electrotherapy and no treatment. When compared to sham electrotherapy, clinically important benefits were seen in pain at less than and equal to 3 months. An unclear effect was seen for quality of life, with 1 outcome indicating a clinically important benefit while another indicated no clinically important difference. Otherwise, there was no clinically important difference seen in mild and moderate/major adverse events. When compared to no treatment, clinically important benefits were seen in quality of life, pain and psychological distress, with no clinically important difference in physical function. The outcomes were of low-very low quality and based on small studies. For each comparison to other interventions the majority of outcomes indicated no clinically important difference. However, a clinically important harm was seen in physical function when compared to transcutaneous electrical nerve stimulation based on 1 small study (N=38). An unclear effect was seen in quality of life when compared to ultrasound, with 1 outcome indicating a clinically important benefit while another indicated no clinically important difference based on 1 small study (N=53).

The committee took these results into consideration when evaluating the individual therapies. As they concluded that there was insufficient evidence of consistent benefit with any individual treatments, they agreed that while there was some evidence of benefit for the combination the effect was at times unclear and based on low quality evidence. Overall, they concluded that there was no indication from the available evidence that a combination of electrotherapy procedures would have more benefit than the individual therapies.

Weighing up the clinical benefits and harms

The committee noted that despite there being a large number of trials, the vast majority had very small sample sizes (with <50 participants in each study arm) and there was inconsistency in the findings which reduced their confidence in the evidence. This taken into consideration led them to conclude that there was insufficient evidence of high quality to form recommendations for this topic. Due to this being present throughout the evidence in this review, they recommended not offering the following electrotherapy treatments: transcutaneous electrical nerve stimulation (TENS), ultrasound, interferential therapy, laser therapy, pulsed short-wave therapy, neuromuscular electrical stimulation (NMES) because of the insufficient evidence of benefit.

On weighing up the effects seen from the treatments investigated in this review, the committee agreed that extracorporeal shockwave therapy showed potential evidence of benefit. However, the quality of the evidence was insufficient to conclude that this was evidence was accurate. Therefore, the committee agreed the research recommendation should investigate the effect of this treatment specifically.

1.1.12.4. Cost effectiveness and resource use

One economic evaluation was identified for inclusion in this review. This was based on a network meta-analysis of randomised controlled trials (RCTs) and took a UK perspective. QALYs were calculated by mapping various measures to the EQ-5D, which were then pooled to give an overall estimate. The study was deemed to be directly applicable to the review question.

The time horizon of the model was relatively short at 8 weeks. Unit costs were also taken from 2011/12 and were therefore unlikely to be representative of current NHS practice. The analysis was therefore graded as having potentially serious limitations.

There were three different meta-analyses used in the study, differentiating trials according to their level of grading and time frame within which outcomes were reported:

All trials
Subset of trials that were graded as having a low risk of bias for allocation concealment
Same as point 2 but further restricting trials to those that reported outcomes between 3 and 13 weeks.

The analysis compared usual care to a multitude of electrotherapy options; interferential therapy, laser light therapy, neuromuscular electrical stimulation (NMES), pulsed electromagnetic field (PEMF), pulsed electrical stimulation (PES) and transcutaneous electrical nerve stimulation (TENS) as well as non-electrotherapy options; acupuncture, braces, heat treatment insoles and static magnets. TENS was the only electrotherapy option that was cost effective compared with usual care with a cost per QALY gained of £2,690.

It should be noted that interventions such as laser therapy and ultrasound are commonly a shared resource across the NHS and would not be limited to osteoarthritis as they could feasibly be used for a range of conditions. They would be found in most physiotherapy departments and therefore the physiotherapists time is likely the main cost associated with these treatments. The cost of physiotherapist time was presented to the committee as the main cost associated with these treatments.

Due to the lack of quality evidence in the clinical review, the committee decided that a research recommendation evaluating the clinical and cost-effectiveness of electrotherapy in patients with osteoarthritis was warranted.

The previous osteoarthritis guideline recommended that healthcare professionals consider TENS as an adjunct to core treatments for pain relief. TENS machines can be loaned to an individual for a short period, and if effective, the person is advised to purchase their own. The committee’s decision to not routinely offer electrotherapy to people with osteoarthritis may result in a cost saving, since if TENS machines were purchased directly by a person, the cost will not be incurred by the NHS.

1.1.12.5. Other factors the committee took into account

The committee reflected that electrotherapy is not commonly provided by healthcare professionals in the NHS (when provided it would be more commonly administered by physiotherapists). Laser therapy is the more common modality used, though some people are using extracorporeal shockwave therapy.

The committee noted that electrotherapy was more commonly used by people with osteoarthritis outside of formal medical care. Devices can be purchased and used by patients independent of health care professional involvement. These devices can be expensive for the individual. A lay committee member reported that the advertisement for these devices can be confusing, as there are lots of devices that advertise themselves as better than others, but it is difficult to know which to use and whether using them will lead to any improvements.

The committee noted that the research identified does not appear to represent the diverse population of people with osteoarthritis. They agreed that any further research should be representative of the population, including people from different family backgrounds, and socioeconomic backgrounds, disabled people, and people of different ages and genders. Future work should be done to consider the different experiences of people from diverse communities to ensure that the approach taken can be made equitable for everyone. With this in mind the committee subgrouped their research recommendation by these protected characteristics where appropriate while suggesting that people from each group should be included in the research to ensure that it is applicable to the entire population

1.1.13. Recommendations supported by this evidence review

This evidence review supports recommendation 1.3.9 and the research recommendation on electrotherapy. Other evidence supporting these recommendations can be found in evidence review G.

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Appendices

Appendix A. Review protocols

Review protocol for clinical and cost-effectiveness of electrotherapy in the management of osteoarthritis (PDF, 1.0M)

Table 63. Health economic review protocol (PDF, 933K)

Appendix B. Literature search strategies

What is the clinical and cost-effectiveness of electrotherapy for the management of osteoarthritis?

The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual.¹⁵⁷

For more information, please see the Methodology review published as part of the accompanying documents for this guideline.

B.1. Clinical search literature search strategy (PDF, 943K)

B.2. Health Economics literature search strategy (PDF, 945K)

Appendix I. Health economic model

No original economic modelling was undertaken.

Appendix J. Excluded studies

Clinical studies

Download PDF (930K)

Health Economic studies

Published health economic studies that met the inclusion criteria (relevant population, comparators, economic study design, published 2005 or later and not from non-OECD country or USA) but that were excluded following appraisal of applicability and methodological quality are listed below. See the health economic protocol for more details.

None.

Appendix K. Research recommendations – full details

K.1.1. Research recommendation

What is the clinical and cost effectiveness of extracorporeal shockwave therapy for managing osteoarthritis?

K.1.2. Why this is important

Many treatments have been proposed to help reduce osteoarthritis symptoms, such as pain and reduction in physical function. In this guideline, a lot of treatments have been found to be ineffective based on limited evidence. Electrotherapy was one of these treatments, where the evidence showed a significant amount of heterogeneity in the outcomes, which may be linked to inconsistency in the use of appropriate sham interventions and low quality study design (including trials with very few participants). Given this, the committee agreed that there was insufficient evidence of benefit from electrotherapy to recommend it in this guideline. However, the inconsistency in effect indicated that there is uncertainty in the efficacy, therefore further research may provide a clearer answer. In particular, extracorporeal shockwave therapy showed some evidence of benefit compared to sham. However, this was based on small trials, where the committee agreed that the sham therapy used as a comparator was likely to be an inadequate sham technique to ensure blinding and so did not consider the evidence as conclusive. Therefore, further research into this electrotherapy modality may help to elucidate the true effect.

K.1.3. Rationale for research recommendation

Download PDF (924K)

K.1.4. Modified PICO table

Download PDF (931K)

Final

Evidence reviews underpinning recommendation 1.3.9 and research recommendations in the NICE guideline

Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.

Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.

NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.

Bookshelf ID: NBK589223PMID: 36791245

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Evidence review for the clinical and cost effectiveness of electrotherapy for the management of osteoarthritis: Osteoarthritis in over 16s: diagnosis and management: Evidence review G. London: National Institute for Health and Care Excellence (NICE); 2022 Oct. (NICE Guideline, No. 226.)
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