Hancock MJ (2007)148
Country: Australia
Quality score: 9/13
Initial of reviewer: SG | Trial Design-RCT
Tx duration: 4 wks Final assessments: 3 mos
N screened: 320 N randomized: 240 N completed tx: 240 N attended last fu: 235
Inclusion: Pts with acute LBP (< 6 wks) in the area between the 12th rib and the buttock crease causing moderate pain and disability
Exclusion: present episode of pain not preceded by pain-free period of ≥ 1 mo in which care was not provided, serious spinal pathology, nerve root compromise, NSAIDs use or SM, spinal surgery in the preceding 6 mo, contraindication to NSAIDs and SM | Mean age (yrs) (SD/range): IG1 = 39.5 (15.8), IG2 = 41.1 (15.4)
% of male: IG1 = 58%, IG2 = 54%
Racial composition: NR
Work status: NR
Other socio-demographics: NR
Co morbidities: NR
Prior episode of pain if acute: NR
Prior CAM intervention: NR
Prior surgery related to current complaint: NR | Cause of Pain: N-S
Duration of Pain: Acute, NR
Severity of pain (Grading): NR
Co-interventions: par acetamol 1 g 4 times/d + advise | Groups IG1 (n = 60)– Diclofenac: NSAID; 50 mg twice/d, 4 wks Drop outs: n = 3
IG2 (n = 60) – SM: The algorithm-based approach, Mob or HV thrust aiming to produce motion at the joints of the lumbar spine thoracic spine, sacroiliac joint, pelvis and hip; 2-3 times/wk, 4 wks Drop outs: n = 2
IG3 (n = 60) – Diclofenac + SM + SMo; 4 wks Drop outs: n = 0
CG (n = 60) – Placebo manipulative therapy + placebo diclofenac: NR Drop outs: n = 0 | Outcomes: Pain: NRS (0 – 10); also d to recovery (primary outcome of study)
Disability: RMDQ
Results-
Immediate post tx: Pain: - 2.0 (-0.7 – 0.3) vs. -0.1 (-0.6 – 0.4) Disability: -1.0 (-2.0 – 0.1) vs. -0.7 (-1.8 – 0.4)
Short term: V Pain: - 0.2 (-0.7 – 0.3) vs. 0.0 (-0.5 – 0.4) RMDQ : -0.5 (-1.7 – 0.7) v.s -0.1 (-1.3 – 1.1)
Intermediate: NR
Long term: NR | Outcome instruments: QoL/ well being: global precieved effects: Results:
Immediate post tx at 4 wks 0.2 (95% CI: -0.1 – 0.6) vs. 0.0 (-0.3 – 0.3)
Short term: 0.3 (-0.1 – 0.6) vs. 0.1 (-0.3 – 0.4)
Intermediate: NR
Long term: NR
Harms: NR |
Hurley DA (2004)149
Country: Ireland
Quality score: 6/13
Initial of reviewer: SG | Trial Design-RCT
Tx duration: 8 wks Final assessments: discharge, 6 mos and 12 mos
N screened: 569 N randomized: 240 N completed tx: 240 N attended last fu: 158
Inclusion: Pts aged 18-65 yrs with acute LBP (duration: 4-12 wks) with or without pain irradiation to the buttock or legs
Exclusion: Previous spinal surgery, motor vehicle accidet, systemic disease, concurrent medical or musculoskeletal conditions, contraindication to manual therapy, psychiatric illness, lack of fluence in English RMDQ < 4 points, pregnancy | Mean age (SD/range): IG = 39.6 (11.6), IG2 = 40.2 (12.1), CG = 40.5 (11.3) yrs
% of male: IG = 54%, IG2 = 50%,CG = 52%
Racial composition: NR
Work status: Employed: IG = 19%, IG2 = 23%, CG = 20%
Other socio-demographics: Non-smokers: IG = 49%, IG2 = 42%, CG = 39%
Co morbidities: NR
Prior episode of pain if acute: NR
Prior CAM intervention: NR | Cause of Pain: Work-related
Duration of Pain: Acute, IG = 7.5 (3.1) wks, IG2 = 7.6 (3) wks, CG = 8.3 (2.8) wks
Severity of pain (Grading): NR
Co-interventions: NR
Prior surgery related to current complaint: NR | Groups IG (n = 80)– MT: Mobilization/manipul ation techniques that passively move an intervertebral joint within or beyond its existing ROM described my Maitland; 8 wks Drop outs: D = 26
CG1 (n = 80) – IFT: Omega Inter 4150 portable IFT unit (freq: 3.85 kHz, beat freq: 140 Hz, 130 microsec), spinal nerve root electrode placement method via two Reply 658 carbon silicone self-adhesive electrodes 50 x100 mm; as IG Drop outs: D = 23
CG2 (n = 80) – MT + IFT: Both protocols explained above provided with MT first and then IFT second; as IG Drop outs: D = 27 | Outcomes: Pain: VAS, mean change from baseline Disability: RMDQ-mean chage from baseline
Results-
Immediate post tx Pain: -19.8 vs. -21.4 vs. -24.7 Disability: -4.5 vs. -3.6 vs. -4.7
Short term: NR
Intermediate: Pain: -17.0 vs. -24.6 vs. -20.0 Disability: -4.7 vs. -3.9 vs. -4.6
Long term: Pain: -18.2 vs. -26.5 vs. -25.7 Disabiltiy: -4.7 vs. -4.9 vs. -6.5 | QoL: EQ-5D Weighted Health Index, mean change from baseline Other: short term SF-36 physical functiuoning, mean change from baseline
Immediate post tx: EQ-5D: 0.16 vs. 0.16 vs. 0.15 SF-36: 15.2 vs. 10.6 vs. 14.3 Short term: NR Intermediate: EQ-5D: 0.17 vs. 0.16 vs. 0.16 SF-36: 12.6 vs. 10.1 vs. 14.4 Long term: NR EQ-5D: 0.15 vs. 0.20 vs. 0.25 SF-36: 9.4 vs. 11.7 vs. 21.4 Harms: No AEs were reported. One Pts died due to causes unrelated to LBP or PT |
Farrell, JP (1982) 150
Country: Australia
Quality score: 4/13
Initial of reviewer: ST | Trial Design: RCT
Tx duration: 3x/wk for up to 3 weeks. Final assessments: 3 weeks from date of initial treatment N screened: 56 N randomized: 48 N completed tx: 48 N attended last fu: NR
Inclusion: Either sex aged 20-65 with pain on lumbar movements or straight leg raising, pain centrally or pravertebrally between T12 and gluteal folds, symptoms of 3 wks durations, experienced a pain-free period of 6 mnths prior.
Exclusion: Had other treatment for the current episode of LBP, pregnant, signs of caudaequinal pressure, alterered sensation, reflexes or weakess in lower extremities, previous surgery in the lumbar region, history of fracture in the lower thoracic lumbar region, evidence of systemic disease or carcinoma. | Mean age: IG = 43.4; CG = 41.83
% of male: IG = 67%; CG1 = 58%
Racial composition: NR
Work status: NR
Other socio-demographics: NR
Co morbidities: NR Prior CAM intervention: NR
Prior surgery related to current complaint: NR | Cause of Pain: NR
Duration of Pain: Acute
Severity of pain (Grading): Numerical Rating Scale: (0 – 10)
IG = 4.95 (estimated based on graph) CG1 = 5.25 (estimated based on graph)
Co-interventions: NR | Groups IG (n = 24)– passive mobilisation and manipulation – techniques descrbeid by Stoddart and Maitland. Drop outs: NR
CG (n = 24) – Received 15 minutes of microwave diathermy in a combfortable side-reclining position ; 10 repittioan of isometric abdominal excrcies which the subject also carried out independently another 3-4 times a day; ergonomic instructions which include advice on activities such as lifting, sitting, standoing, carrying objects and rest postures. Drop outs: NR | Outcome instruments: Pain: Mean subjective pain rating (0-10)
Disability: NR
Results:
Baseline:
Pain: (estimated based on graph) IG = 4.95 CG = 5.25
Disability: NR
Immediate post tx: Pain: (estimated based on graph) IG = 3.80 CG = 4.40
Disability: NR
Short term: (estimated based on graph) (after 3rd tx) IG = 2.95 CG = 2.75 (3 wks after initial tx) IG = 0.30 CG = 0.30
Intermediate: NR Long term: NR | Outcome instruments: QoL/ well being:
Results:
Immediate post tx:
Short term: NR
Intermediate: NR
Long term: NR
Harms: NR
Summary Pts with acute LBP treated by passive mobilisation and manipulation had a shorter mean duration of symptoms compared with those who were treated by microwave diathermy, isometric abdominal exercises and ergonomic instructions. |