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National Guideline Centre (UK). Low Back Pain and Sciatica in Over 16s: Assessment and Management. London: National Institute for Health and Care Excellence (NICE); 2016 Nov. (NICE Guideline, No. 59.)
Guideline updates: December 2020: in the recommendation on stopping opioid analgesics NICE added links to other NICE guidelines and resources that support discussion with patients about opioid prescribing and safe withdrawal management. September 2020: NICE's original guidance on low back pain and sciatica in over 16s was published in 2016. It was partially updated in September 2020. See the NICE website for the guideline recommendations and the evidence review for the 2020 update. This document preserves evidence reviews and committee discussions for areas of the guideline that were not updated in 2020.
12.1. Introduction
Manual therapy interventions use passive or active assisted movements, usually delivered by the hands of the practitioner. Typically, they aim to act on the neuromusculoskeletal system focussing on joints and soft tissues to improve mobility and function, and to decrease pain. Techniques include spinal manipulation (a gapping motion of a synovial joint within a spinal segment in response to a force of typically short duration), spinal mobilisation (joint movement within the normal range of movement) and soft tissue techniques (manual manipulation/mobilisation of soft tissues).133
Mobilisation and soft tissue techniques are performed by a wide variety of practitioners; whereas spinal manipulation is usually performed by chiropractors or osteopaths, and by doctors or physiotherapists who have undergone additional training in spinal manipulation. Manual therapists often combine a range of techniques in their approach and may also include exercise interventions and advice about self-management.
Research into manual therapy often uses pragmatic trials to determine effectiveness. This reflects the complex nature of the intervention, the inability to blind the practitioner, and the challenges of blinding participants and designing suitable sham or placebo controls.
In addition to the descriptions above, the GDG classified interventions as mixed modality manual therapy where they included more than one type of manual therapy.
12.2. Review question: What is the clinical and cost effectiveness of manual therapies in the management of non-specific low back pain and sciatica?
For full details see review protocol in Appendix C.
Table 165PICO characteristics of review question
| Population |
|
|---|---|
| Intervention(s) |
|
| Comparison(s) |
|
| Outcomes | Critical
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| Study design | RCTs and SRs will be included in the first instance. If insufficient RCT evidence to form a recommendation is found, non-randomised studies will be included. |
12.3. Clinical evidence
12.3.1. Summary of studies included
12.3.1.1. Single interventions
Forty eight studies, of which 3 reported in multiple studies for a total of 55 papers, were included in the review.5,41-43,46,52-54,60,61,74,76,119,129,137,152,154,163,185,187,197,198,203,224-226,231,236-238,258,275,280,303-305,307,344,345,354,360,393,397,408,412,434,440,442,445 492,506,522,528,562,564 These are summarised in Table 166 below. Evidence from these studies is summarised in the GRADE clinical evidence profile/clinical evidence summary below (Table 171). See also the study selection flow chart in Appendix E, study evidence tables in Appendix H, forest plots in Appendix K, GRADE tables in Appendix J and excluded studies list in Appendix L. A comparison between electrotherapy and manual therapy 538 is included in the electrotherapy chapter (See Chapter 14). Other comparisons from the Little et al. 311 and Ferreira et al. 137 can be found in the self-management chapter (See Chapter 8). Other comparisons from Zylbergold et al.344,564 and Petersen et al.404 are included in the exercise chapter (See Chapter 9). Seven Cochrane reviews were identified on manual therapies but could not be included for the following reasons:
Table 166
Summary of studies included in the review: single intervention.
- the review was withdrawn from publication;20
- the review excluded spinal manipulation interventions if not in combination with other interventions, and included comparator interventions that were not considered in this guideline, for example nutritional advice;530
The studies included in these Cochrane reviews were individually assessed and included if they matched the review protocol.
12.3.1.2. Combination of interventions
Eighteen studies, of which 5 reported in multiple reports for a total of 25 papers looking at combinations of non-invasive interventions (with manual therapy as the adjunct) were also included in this review.24,45,50,77,113,131,155,195,199,311,386,388,389,405,418,439,479,498,499 Evidence from Szulc et al. 344,479 and from UK BEAM Trail Team 2004499 is also included in the exercise chapter (See Chapter 9). These are summarised in Table 167 below. Evidence from these studies is summarised in the GRADE clinical evidence profile/clinical evidence summary below (Table 201) See also the study selection flow chart in Appendix E, study evidence tables in Appendix H, forest plots in Appendix K, GRADE tables in Appendix J and excluded studies list in Appendix L.
Table 167
Summary of studies included in the review: combinations – manual therapy adjunct.
12.3.1.3. Heterogeneity
For the comparison of manipulation/mobilisation versus usual care, in the mixed population, there was substantial heterogeneity between the studies when they were meta-analysed for the outcome of function (RMDQ) at ≤4 months. Pre-specified subgroup analysis (different within-class modalities, i.e. high velocity thrust; spinal adjusting – mobilisation; traction gap spinal manipulation) explained the heterogeneity; however, this was because there was only 1 study in each of these modalities. The other pre-specified subgroup analysis (chronicity of pain) was unable to be performed on this outcome because the studies were not different in terms of this factor.
For the comparison of mixed modality manual therapy versus sham, in the mixed population, there was substantial heterogeneity between the studies when they were meta-analysed for the outcome of pain (NRS) at > 4 months. Pre-specified subgroup analysis (different within-class modalities) explained the heterogeneity; however this was because there was only 1 study in each of these modalities. The other pre-specified subgroup analysis (chronicity of pain) was unable to be performed on this outcome because the studies were not different in terms of this factor.
12.3.2. Clinical evidence summary tables
12.3.2.1. Soft tissue technique
12.3.2.2. Traction
Table 176. Clinical evidence summary: Traction versus sham in low back pain without sciatica
Table 178. Clinical evidence summary: Traction versus usual care in low back pain with sciatica
12.3.2.3. Manipulation/mobilisation
12.3.2.4. Mixed modality manual therapy
12.3.2.5. Combinations – manual therapy adjunct
12.4. Economic evidence
Published literature
One economic evaluation was identified that included soft tissue techniques as a comparator and has been included in this review.225 This is summarised in the economic evidence profile below (Table 227) and the economic evidence table in Appendix I. This was a within-trial analysis of the ATEAM RCT also included in the clinical review.310 The analysis included eight comparators with combinations of usual care, self-management (unsupervised exercise - exercise prescription), manual therapy (soft tissue techniques – massage) sessions and Alexander technique lessons. Results are summarised here for the soft tissue technique comparator as an adjunct to other care only. Other comparators are presented as part of the relevant sections of the non-invasive interventions review. The full incremental analysis including all comparators in the study is presented in Table 228 below.
Table 227
Economic evidence profile: soft-tissue techniques – usual care comparisons only.
Table 228
Economic evidence profile: soft-tissue techniques – full incremental analysis of all comparators.
One economic evaluation was identified that included manipulation/mobilisation as a comparator and has been included in this review.516 This is summarised in the economic evidence profile below (Table 229) and the economic evidence table in Appendix I.
Table 229
Economic evidence profile: manipulation/mobilisation studies – usual care comparisons only.
One economic evaluation was identified that compared manipulation/mobilisation in combination with biomechanical exercise and self-management compared to self-management alone (Niemisto 2003388/Niemisto 2005387). In addition, two economic evaluations were identified that included mixed manual therapy – one includes mixed manual therapy in combination with self-management and in combination with both self-management and biomechanical exercise compared to self-management alone and a combination of self-management and biomechanical exercise (Beam 2004498) and the other looks at biomechanical exercise, a combination of mixed manual therapy and self-management, and an MBR programme.94 These are summarised in the economic evidence profile below (Table 230 and Table 231) and the economic evidence table in Appendix I.
Table 230
Economic evidence profile spinal manipulation therapy and self-management versus self-management.
Table 231
Economic evidence profile: manual therapy versus self-management programme.
No relevant economic evaluations were identified that included traction or mixed modality manual therapy as a comparator.
One economic evaluation relating to soft tissue techniques, four relating to manipulation/mobilisation and one relating to mixed modality manual therapy were identified but excluded due to limited applicability.74,85,91,208,284,444 One economic analysis (with two publications) relating to traction was identified but excluded due to serious methodological limitations.140,302 A further two economic evaluations relating to manipulation/mobilisation were identified but selectively excluded due to a combination of limited applicability and methodological limitations.96,150 These are listed in Appendix M, with reasons for exclusion given.
One economic evaluation was identified that included manipulation/mobilisation as a comparator but compared to injection therapies.405 This study was therefore considered as part of the injection therapy review as per the protocol.
See also the economic article selection flow chart in Appendix F.
Table 232. Economic evidence profile: mixed manual therapy plus self-management
Unit costs
Relevant unit costs are provided below to aid consideration of cost effectiveness.
For manual therapy interventions the relevant unit costs will be personnel time. An appointment with a physiotherapist would be required. The cost of a non-admitted face to face first attendance in physiotherapy costs £51, and a follow-up attendance costs £39.110 Other healthcare professionals may provide these interventions including an osteopath, chiropractor or muscular skeletal physician.
12.5. Evidence statements
12.5.1. Clinical
12.5.1.1. Soft-tissue techniques
Evidence for soft-tissue techniques was exclusively from a population of low back pain without sciatica. Data from 1 study (2 distinct populations) suggested a borderline clinically important reduction in pain as measured by VAS at 4 months for soft-tissue techniques (massage) when compared with sham (very low quality; n = 72). However, this benefit was not demonstrated by further evidence from 2 studies using the McGill pain scale (very low quality; n = 146) nor was any difference between soft tissue techniques (massage) and sham observed for function at less than 4 months (low quality; n = 146). When compared with usual care, no clinically important improvement was seen in quality of life (2 studies; very low quality; n = 473) or pain (1 study; moderate quality; range of n = 223 - 231), at either short or long term. There was a clinically important improvement in function (RMDQ) at less or equal to 4 months, but this was not sustained at greater than 4 months (2 studies; very low quality; range of n = 473 - 474). When soft tissue techniques (massage) was compared with acupuncture and with self-management, no clinical difference in function (RMDQ) was observed for the acupuncture comparison (1 study; very low to low quality; n = 166); however, there was clinical benefit of soft tissue techniques (massage) over self-management at less or equal to 4 months but not in the longer-term follow up (1 study; very low to low quality; range of n = 159 - 160).
No data were identified for other outcomes in these comparisons.
12.5.1.2. Traction
When compared with sham, evidence demonstrated a clinically important reduction in pain at less than 4 months for patients receiving inversion traction in a mixed population of people with low back pain with or without sciatica (1 study; moderate quality; n = 29), but not among those who received mechanical traction (1 study; moderate quality n=150), nor in the longer term (1 study; high quality; n=148). Similarly, no clinically important difference was observed for function (1 study; moderate and high quality; range of n= 148-150). Use of other medical treatments was increased in the traction group compared to sham treatment in the short term, but this between group difference was not sustained at the longer term follow-up (1 study; low-moderate quality; range of n= 148-150). Additionally, the benefit for pain intensity was not replicated for those without sciatica (1 study; moderate quality; n=60).
When compared with usual care, a clinically important benefit in each individual quality of life domain score was demonstrated for people with low back pain and sciatica in favour of traction, but only in the subgroup of participants who received weight-bath traction (1 study; very low quality; n = 36) and not mechanical traction (1 study; very low quality; n=64), and no clinical benefit was seen for function measured with ODI (2 studies, low quality; n = 100). Similarly, no clinical benefit was seen for traction compared with usual care in 1 small study for pain or function (very low quality; n = 39) in a mixed population with low back pain with or without sciatica.
In comparison with biomechanical exercise, evidence from 1 study suggested that there was a lower number of visits to other healthcare practitioners in those receiving traction (moderate quality; n=191).
No data were identified for other outcomes in these comparisons.
12.5.1.3. Manipulation/mobilisation
In the population of low back pain without sciatica, no clinically important difference between manipulation/mobilisation and sham was demonstrated for pain in the short term (5 studies; moderate quality; n = 533) or long term (2 studies; high quality; n=229), function in the short (ODI: 4 studies; low quality; n = 374. Von Korff: 1 study; moderate quality; n=174) and long term (ODI: 1 study; moderate quality; n=63. Von Korff: 1 study; moderate quality; n=166), or quality of life at any time point (very low to high quality), with the exception of SF-36 physical composite at less or equal to 4 months (moderate quality, 1 study, n=174). No data for other outcomes were identified. When spinal manipulation was compared to sham in the population of low back pain with sciatica, a single study showed long-term clinical benefit of spinal manipulation for quality of life in the majority of domains, except for the general health domain, where a clinical benefit of sham was observed, and the role physical and bodily pain domains, where no difference between groups was observed (1 study, moderate-high quality evidence; n=98). Evidence from the same study also showed clinical benefit of spinal manipulation in terms of responder criteria (>30% improvement in pain) in the long term (low quality; n-98).
For the population of low back pain with or without sciatica, evidence mainly from individual studies suggested clinical benefit with uncertainty around the effect size for manipulation/mobilisation when compared with usual care on function (RMDQ at less or equal to 4 months, only in the subgroup receiving traction gap manipulation: 1 study; low quality; n=29) and quality of life (physical function domain at less or equal to 4 months: 1 study; low quality; n=240). No improvement in pain between the groups was seen at either time point (very low to moderate quality; range of n = 681 - 921). The number of healthcare visits was increased in the population receiving spinal manipulation compared to usual care in both the short and long term (1 study, low-moderate quality, n= 330 - 338). No data were identified for other outcomes.
When manipulation/mobilisation was compared with usual care in people with low back pain and sciatica, one study (very low quality; n=192) showed no clinical benefit for pain and quality of life (except for the physical health composite), but fewer adverse events were reported in the spinal manipulation group. The same study showed clinical benefit for function at less or equal to 4 months but not at greater than 4 months (very low quality, n=192).
For people with low back pain only (without sciatica), no clinically important differences were seen compared to usual care for function at either short (2 studies, very low quality, n=197,) or long term (1 study; very low quality; n=72), pain (1 study; low quality; n=72) or occurrence of adverse events (1 study, n =72, low quality) in the long term. However, clinically important benefits in terms of pain at less or equal to 4 months (1 study; low quality; n=72) and responder criteria (pain and function) were demonstrated (1 study; low quality; n = 72).
When compared with other active treatments (soft tissue technique (massage), belts/corsets, interferential therapy, ultrasound, self-management, NSAIDs), the majority of outcomes demonstrated no clinically important difference. In the population of low back pain with or without sciatica, evidence showed clinical benefit of manipulation/mobilisation compared to exercise in pain and function at less or equal to 4 months (1 study; very low quality; n=24). When manipulation/mobilisation was compared to interferential therapy in the population of low back pain with or without sciatica, some evidence showed a clinically important improvement in quality of life in the group receiving manual therapy (SF-36 domains of physical function and social function at less than 4 months; bodily pain, social function and mental health at greater than 4 months; 1 study; very low to low quality; n= 107 - 128); however, there was also evidence favouring interferential therapy (EQ-5D greater than 4 months; 1 study; low quality; n=128). In people with low back pain without sciatica, there was clinical benefit for pain (but not function) both in the short and long term when manipulation/mobilisation was compared to ultrasound (1 study; very low quality; n = 73 -112). When manipulation/mobilisation was compared to a combination of interventions (exercise + education) in low back pain with or without sciatica, clinical benefit was reported by a small study for pain and function at less or equal to 4 months (very low quality; n=23).
12.5.1.4. Mixed modality manual therapy
Evidence from one small study comparing mixed modality manual therapy to usual care in a population with low back pain showed clinical benefit for pain severity (n=18; very low quality). Mixed modality manual therapy compared with sham treatment in people without sciatica demonstrated a clinically important benefit in the responder criteria (pain reduction) at less or equal to 4 months (moderate quality, n=455). In the mixed population of low back pain with or without sciatica there was no clinical benefit in terms of pain or function (1 study; moderate quality; n=29). In the population with low back pain only (without sciatica), mixed modality manual therapy showed a benefit for pain at less than 4 months, when compared to traction (1 study, very low quality n=60) and when compared to biomechanical exercise (1 study, very low quality, n=18). Single studies comparing mixed modality manual therapy to spinal manipulation and soft tissue technique (massage) did not show any clinically important difference (very low to low quality; range of n=89 – 97).
12.5.1.5. Combinations of interventions – manual therapy adjunct
The evidence (ranging from very low to high quality) showed that there was no clinical benefit or difference between active treatments for the majority of outcomes and nearly all combinations of non-invasive interventions that had manual therapy as an adjunct, with a few exceptions as detailed below.
12.5.1.5.1. Low back pain with sciatica
The combination of manual therapy (soft tissue techniques – muscle energy technique) plus biomechanical exercise (McKenzie) plus self-management (unsupervised exercise) compared to a combination of massage, TENS, laser and self-management showed a benefit for pain and function at less than 4 months (1 study; very low quality; n=40).
12.5.1.5.2. Low back pain without sciatica
Manual therapy (massage) with self-management (exercise prescription) versus postural therapy (Alexander technique – 24 lessons) showed long-term benefit in terms of quality of life favouring postural therapy (1 study, low quality, n=117). For manual therapy (manipulation) plus exercise (either biomechanical or aerobic) versus exercise, clinical benefit favouring the addition of spinal manipulation was observed for short term pain (spinal manipulation plus biomechanical exercise versus aerobic or biomechanical exercise, very low quality, 1 study, n=39) and for short term function (spinal manipulation plus biomechanical or aerobic exercise versus aerobic exercise, very low quality, 1 study, n=36).
12.5.1.5.3. Low back pain with or without sciatica (mixed population)
Manual therapy (manipulation/mobilisation) plus self-management (home exercise) compared to self-management plus exercise showed clinical benefit of the comparator (self-management plus exercise) for pain when measured both at short and long term follow up, and function only in the short-term (moderate quality, 1 study, n=48).
No benefit was seen when traction was combined with infra-red therapy and exercise except for a reduction in medication use both in the short and long term (1 study, very low quality, n=71).
Manual therapy (manipulation) plus electrotherapy (interferential) compared with electrotherapy (interferential) showed clinical benefit for several quality of life measures (low quality, 1 study, n=106 or n=131) but these differences were inconsistent across domains and in terms of whether they occurred in the short or long term. No difference between treatments in terms of pain or function was observed for this comparison.
A decrease in medication use and an improvement in function was observed when manual therapy (manipulation) plus biomechanical exercise was compared to biomechanical exercise in 1 study (n=92, very low quality).
Mixed modality manual therapy when combined with either self-management, or when combined with biomechanical exercise and self-management demonstrated clinical benefit for quality of life measures - EQ-5D in the short and long-term (low quality, 1 study, n=543-688), SF-36 physical composite in the short and long term (including biomechanical exercise, low quality, 1 study, n=442-458), and SF-36 physical composite in the short term (without biomechanical exercise, low quality, 1 study, n=486) when compared against self-management. No difference was seen in critical outcomes for pain or function, but responder criteria for improvement in function demonstrated a benefit in both comparisons in the short and long term (1 study, low-very low quality, n=480-515). No difference was seen in any outcomes when mixed modality manual therapy combined with self-management was compared against biomechanical exercise combined with self-management (moderate quality, 1 study, n=49).
When manual therapy (spinal manipulation plus massage) was compared against self-management and exercise (biomechanical – McKenzie), a benefit in the responder criteria for improvement in function in the short term favouring self-management and exercise was observed (1 study; moderate quality; n=329).
Manual therapy (manipulation) with self-management (advice) and pharmacological therapy (NSAIDs) demonstrated clinical benefit on short and long-term function, short term quality of life (SF-36 physical function domains) and long term quality of life (SF-36 bodily pain domain) (low and moderate quality, 1 study, n=71 or 72) when compared to usual care.
12.5.2. Economic
- One cost-utility analysis (partially applicable; potentially serious limitations) in people with low back pain (without sciatica) found:
- Compared to usual care, soft tissue techniques (massage) in combination with usual care was not cost effective (lower QALYs and higher costs), but was cost effective when used as an adjunct to unsupervised exercise (exercise prescription).
- When considered amongst a selection of active treatments (each in combination with usual care), the combination of Alexander technique (24 lessons) with unsupervised exercise (exercise prescription) was the most effective (highest QALYs) and most cost effective option from usual care, unsupervised exercise (exercise prescription), soft tissue techniques (massage), exercise prescription with massage, Alexander technique lessons (6 lessons), exercise prescription and Alexander technique lessons (6 lessons), Alexander technique (24 lessons), and exercise prescription with Alexander technique (24 lessons).
- One cost-consequence analysis was identified relating to mixed modality manual therapy in combination with self-management and biomechanical exercise compared to self-management alone in people with low back pain or sciatica: the combination did not show any statistically significant increase in costs or outcomes. This was assessed as partially applicable with potentially serious limitations.
- One cost-utility analysis found that mixed modality manual therapy plus self-management was cost-effective compared to a combination of mixed modality manual therapy, biomechanical exercise and self-management, self-management in combination with biomechanical exercise, and self-management alone for the treatment of low back pain without sciatica (ICER: £8,700 per QALY gained). This analysis was assessed as partially applicable with minor limitations.
- One cost-utility analysis found that manual therapy plus self-management was dominated (more effective and less costly) by a 3 element MBR programme (physical, psychological, educational) for treating low back pain (without or without sciatica). This analysis was assessed as partially applicable with potentially serious limitations.
- No relevant economic evaluations were identified relating to soft tissue techniques or manipulation/mobilisation in people with sciatica.
- No relevant economic evaluations were identified relating to traction in people with low back pain or sciatica.
12.6. Recommendations and link to evidence
| Recommendations |
|
|---|---|
| Relative values of different outcomes | The GDG agreed that the most critical outcome for decision making were health-related quality of life, pain severity, function and psychological distress. It was noted that the latter 3 were individually critical outcomes as well as components of quality of life measures. Adverse events were considered important for decision making because experience of adverse events may outweigh the possible benefits gained from manual therapy. Similarly, any difference in healthcare utilisation was considered an important outcome likely to reflect any benefits in quality of life experienced. The GDG discussed the importance of responder criteria as an outcome and agreed that although important in decision making, due to the inherent difficulties in dichotomising continuous outcomes this was not a critical outcome. |
| Trade-off between clinical benefits and harms | The GDG discussed the necessity of a body of evidence to show specific intervention effects, that is, over and above any contextual or placebo effects. It was therefore agreed that if placebo or sham-controlled evidence is available, this should inform decision making in preference to contextual effects. However, if there was a lack of placebo or sham-controlled evidence, evidence against usual care will be given priority when decision making. There was mixed evidence for the effectiveness of manual therapy modalities, particularly with function outcomes not correlating with quality of life outcomes. It was also difficult to assess evidence from a wide variety of interventions for traction, and for manipulation/mobilisation. The GDG discussed that there was some albeit limited evidence of benefit of soft tissue techniques, spinal manipulation and mixed modality manual therapies compared to sham treatments in terms of improving pain or quality of life. Where these benefits were observed in the short term follow up they were somewhat inconsistent, and were not maintained in the longer term. Evidence compared to usual care was conflicting and did not consistently show benefit when manual therapy was offered as a single treatment. However, when offered in combination with self-management and exercise, evidence from a large multicentre study demonstrated benefits in terms of quality of life and in terms of responder criteria for function. The GDG agreed the benefits seen by the package of therapy including mixed modality manual therapy was supportive of the evidence observed from evidence of mixed modality manual therapy from smaller trials in the review. For the critical outcomes where manual therapy was a single intervention, there was little effect seen beyond four months. One mixed modality trial in combination with other treatments did report positive outcomes for quality of life in both short and longer term and similarly for responder analysis for functional improvement. The GDG discussed whether the passive nature of manual therapies might explain why effects were not usually seen beyond four months. Adverse events were common, minor and transient, consisting mainly of muscle soreness for a few days following treatment. No serious events attributable to manual therapy were reported by the studies reviewed. The GDG were aware of possible serious but very rare adverse events that may be related to spinal manipulation and took this into account when making a recommendation. The GDG discussed that when considered alongside the body of evidence for soft-tissue techniques, manipulation/mobilisation or mixed modality manual therapies, there was very limited evidence of benefit for traction as a single therapy. Some benefit was observed in people with low back pain and sciatica when compared to usual care, but the GDG did not consider this as sufficient evidence of effect as it was from a small single study (n=36) and the evidence was rated as very low quality. Further benefits were seen from a group who received weight-bath traction when compared to usual care (separated from a group receiving mechanical traction). However, it was discussed that all of the participants in this trial were inpatients admitted due to sciatica and therefore were unlikely to be representative of the broader population with sciatica. Furthermore, there was also an indication from one study in people with low back pain with or without sciatica that healthcare utilisation was increased in the group that received traction compared to sham treatment in the short term. Although when compared to biomechanical exercise the converse was true, the GDG noted that this healthcare utilisation data should be interpreted with care as it did not include the resource use associated with provision of the intervention itself. Therefore the GDG agreed that traction should not be offered for low back pain or sciatica. Combinations of interventions The majority of the evidence for combinations of interventions was from a mixed population of those with low back pain with or without sciatica. The GDG noted that evidence suggested manual therapy was possibly potentiated when provided in combination with exercise in terms of providing benefit in pain and function for people with low back pain. However, it was noted that the evidence for this was limited and mostly came from single studies. The evidence for these combined interventions was challenging to unravel, because the combinations themselves and the comparator groups differed widely in terms of the intervention that they comprised. The studies used any one (or a combination) of a number of different modalities/types of manual therapy. The interventions were also often given in combination with other interventions, which differed in each trial, and were also compared to single or combinations of various different interventions. It was therefore very difficult to pick out which type of adjunct and combination of interventions was most effective. However, there was some inconsistent evidence of clinical benefit (in terms of pain, function, quality of life or responder criteria) when the intervention contained mixed modality manual therapy or a spinal manipulation component. The large multicentre study in particular showed that mixed modality manual therapy demonstrated clinical benefit for quality of life (SF-36 physical and EQ-5D) as well as for responder criteria (improvement in RMDQ function) in both the short and longer term. The GDG noted that the responder evidence for mixed manual therapy came from post-hoc analyses of 2 trials. In addition one of these trials demonstrated benefit in terms of responder analysis for pain, but not for function, whereas the other trial only presented the (positive) results of responder analysis for function; demonstrating a lack of consistency across important outcomes. Post hoc analyses present a further risk of bias. The GDG felt that, for these reasons, the evidence from the responder analyses should be considered with caution. Summary Overall the GDG concluded that there was mixed evidence for the effectiveness of manual therapy modalities. For soft-tissue techniques, the evidence was based on massage. Considering that a comparison with usual care should result in a greater effect estimate than the specific effect of the intervention (as demonstrated in placebo comparisons), the GDG felt that the absence of a clinically important improvement in quality of life and pain in this comparison indicated sufficient evidence of absence of effect to recommend against the use of soft tissue techniques (massage) on its own. Similarly, based on the limited clinical benefit seen for mobilisation/manipulation, the GDG felt this form of manual therapy could not be recommended for low back pain or sciatica as an independent intervention. The GDG concluded that soft-tissue techniques (e.g. massage) and manipulation/mobilisation should only be considered as part of treatment packages, where benefits were observed and seen to be maintained in the longer term. The GDG were aware of possible risk of adverse events, and due to the conflicting nature of the evidence, the GDG agreed that this recommendation should be to consider manual therapy as part of treatment package, rather than to offer manual therapy alone as a sole intervention to all people with low back pain with or without sciatica. The GDG did not feel that manual therapy should be a mandatory component of a treatment package, but that it is one optional modality that might be considered alongside exercise. |
| Trade-off between net clinical effects and costs | Soft tissue techniques One relevant economic evaluation was included that considered soft tissue techniques (massage) in a population with low back pain without sciatica. This was based on the RCT reported by Little et al. included in the clinical review. This within-trial analysis found that, compared to usual care, soft tissue techniques (massage) was found not to be cost effective when given alone (it had lower QALYs and higher costs), but was cost effective when used as an adjunct to self-management (unsupervised exercise - exercise prescription). Given the wide use of self-management in low back pain these results suggest uncertainty in the cost effectiveness of massage. In addition, when considered amongst a selection of active treatments, the combination of Alexander technique (24 lessons) with unsupervised exercise (exercise prescription) was found to be the most cost effective option from usual care, unsupervised exercise (exercise prescription), soft tissue techniques (massage), exercise prescription with massage, Alexander technique lessons (6 lessons), exercise prescription and Alexander technique lessons (6 lessons), Alexander technique (24 lessons), exercise prescription with Alexander technique lessons (24 lessons). Given the uncertainty around cost effectiveness from this study and the overall lack of evidence relating to soft tissue techniques from the clinical review, the GDG concluded there was insufficient evidence to conclude that it would be cost effective for the NHS. Traction No economic evaluations were identified from the published literature. Use of traction will be associated with costs relating to the equipment and personnel time required to deliver the therapy. If effective, upfront costs may be offset by downstream cost savings due to reduced healthcare utilisation or may be justified due to the benefits to the patient. Although some indications of possible benefit were seen for traction in a sciatica population, overall the GDG concluded that it was insufficient to support a conclusion of evidence of clinical benefit and thus also insufficient to justify intervention costs. Manipulation/mobilisation One relevant economic evaluation was included that considered manipulation/mobilisation in a population with low back pain without sciatica. This was based on the RCT reported by Haas et al. 2014 included in the clinical review. This within-trial analysis suggests, based on unadjusted data, that manipulation (12 sessions) may be cost-effective (£14,800 per QALY gained). It used a sham comparator but note that the cost of providing the sham is appropriately not included in this calculation. However, the authors also undertook a regression analysis to adjust costs and QALYs and in this analysis the QALY gain was reduced – this is not fully reported but appears that it may be as low as no difference – this would potentially reduce the cost effectiveness estimate. However, also of note the sham comparator would be expected to underestimate treatment benefits compared to a usual care comparator and this may improve cost effectiveness. Uncertainty around cost effectiveness was not reported. The adjusted costs analysis reported the difference as not statistically significant however this analysis excluded the intervention costs. QALY differences were also reported as not statistically significant. The study limitations include the setting which is the USA - this has low applicability to the UK due to the differences in the health care systems which can translate to differences in resource use and costs. Overall, while this study suggests that manipulation could potentially be cost effective but there are a large number of uncertainties in this evidence. One study by Niemisto et al (2003) compared manual therapy as part of a combination manual therapy, self-management, and biomechanical exercise with self-management alone. The authors reported no difference in health-related quality of life at 2 years between the two interventions and the increase in costs with the combination intervention was £25 after 1 year and £56 after 2 years. However this increase was reported as not statistically significant. Therefore it was not possible to make any definite conclusions from this study. Mixed modality manual therapy In the UK BEAM analysis, the self-management and mixed modality manual therapy arm had most QALYs and the most costs. Sub-analysis showed that with mixed modality manual therapy unavailable it would be cost-effective to add exercise and vice versa. This study was deemed to have minor limitations. Another UK study showed that mixed manual therapy plus self-management is more cost effective than biomechanical exercise alone; however when all the comparisons evaluated in the study were considered, a three-element MBR programme with physical, psychological and education components was the cheapest and more effective option. The GDG considered the uncertainty in the economic evidence and felt that manual therapy may not be cost effective as a standalone intervention; however, the GDG considered that cost effectiveness might be more likely if manual therapy is provided as part of a treatment package including exercise with or without psychological therapy. |
| Quality of evidence | The majority of the evidence on soft tissue techniques was of low to very low quality. The quality was downgraded in most cases due to a combination of imprecision of the effect estimate and the risk of bias, which in most cases was high due to unclear allocation concealment and lack of blinding for subjective outcomes. The majority of the evidence informing the comparison of traction with sham was of moderate to high quality. The quality was downgraded in most cases due to imprecision of the effect estimate while the risk of bias was felt to be low. The evidence for traction compared with usual care or other active therapies ranged from low to very low quality, in most cases this was due to imprecision of effect estimate along with a high risk of bias. The majority of the evidence informing the comparison of spinal manipulation with sham was of moderate to high quality. Quality was downgraded in most cases due to imprecision of the effect estimate while the risk of bias was felt to be low. The evidence for spinal manipulation compared with usual care or other active therapies ranged from moderate to very low quality, in most cases this was due to imprecision of effect estimate along with a high risk of bias. The majority of the evidence for mixed modality manual therapy was of low to very low quality. In most cases quality was downgraded due to a high risk of bias (e.g. selection bias, lack of blinding), and in some cases was further downgraded due to imprecision of the effect estimate. The GDG noted that a large trial included in the combinations evidence was helpful in informing the manual therapy recommendation, because this large study showed clinical benefit of mixed modality manual therapy. However, the GDG did note that the evidence from this study was mostly rated as low quality (due to high drop-out rates and lack of blinding) and that the clinical benefit for function came from a post hoc analysis of the data. The responder analyses for pain and function from two large trials of manual therapy informed the GDG's recommendation. The trials had evidence varying from medium to very low quality, and with some uncertainty about the magnitude of the differences between the groups. The GDG were aware of the limitations of responder analyses: responder analyses have reduced power to detect differences compared to analyses on the original scales, that there is a natural recovery rate observed in both intervention and comparator arms and ‘responders’ have not necessarily improved due to the intervention, and that the distribution functions of the dependent variables are similar in both groups. The GDG considered that the cut-offs chosen for the responder analyses reflected clinically important differences in the mean responses between the groups but were mindful that some patients may have had worse outcomes in both the intervention group and comparator groups. As well as the concerns of responder criteria, the GDG further noted that 2 of these were post-hoc analyses which raised further concerns about the reliability of this analysis. The GDG discussed that the post hoc nature of the responder analyses in these 2 trials introduces a risk of bias due to the potential for data mining. The GDG reflected their concerns about responder analyses in the strength of their recommendation and chose to advise ‘consider’ manual therapies as part of a treatment package. The GDG were aware of the difficulties with providing adequate patient blinding to manual therapy treatments as sham or placebo interventions may have contextual or primary therapeutic effects, which may reduce the differences between groups. Conversely, subjects may be able to detect if they are receiving sham treatment and this may amplify a true difference between groups because subjects in the sham group may be adversely affected psychologically. |
| Other considerations | For recommendations on exercise therapies, psychological interventions, and multidisciplinary biopsychosocial rehabilitation, please see chapters 9, 15 and 17, respectively. It was noted that the evidence was mixed as to whether it related to people with low back pain only, low back pain and sciatica, or mixed populations with or without sciatica, with the exception of soft-tissue therapies offered in isolation where evidence was only identified for people without sciatica. The GDG agreed that there was sufficient evidence to assume the effects for a combination of therapies would apply equally to those with low back pain with or without sciatica and therefore recommended these should be considered for either condition. |
- Manual therapies - Low Back Pain and Sciatica in Over 16s: Assessment and Manage...Manual therapies - Low Back Pain and Sciatica in Over 16s: Assessment and Management
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