| Study characteristics |
| Methods |
Study design: RCT (NCT00269347)
Setting: USA, general population
Exercise groups: 2
Comparison groups: 1 |
| Participants |
Number of participants: 301 (E1 = 100, E2 = 101, C1 = 100)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: Some participants
Mean age (years): 45
Sex (female): 61% |
| Interventions |
Exercise Group 1 (E1): Dynamic trunk strengthening exercises (trunk extensions and leg extensions), abdominal exercises using low‐technology methods; type = core strengthening; duration = 12 weeks; dose = high; design = partially individualised; delivery = individual; additional intervention = not specified
Exercise Group 2 (E2): Simple stretching and strengthening exercises, including lumbar extension, bridging, and abdominal crunches; type = stretching & strengthening; duration = 12 weeks; dose = low; design = individualised; delivery = independent with follow‐up; additional intervention = advice/education
Comparison Group 1 (C1): Other conservative treatment (manual therapy) |
| Outcomes |
Core outcomes reported: Pain (Low Back Pain Rating Scale (Manniche)); function (Roland‐Morris Disability Questionnaire); HRQoL (36‐Item Short Form Survey); Global Perceived Health or Recovery (Global Perceived Health or Recovery (global improvement (9‐point))
Follow‐up time periods available for syntheses: 12 weeks (short); 26 weeks (moderate); 52 weeks (long) |
| Notes |
Conflicts of interest: RHG: consulting: Pfizer (B); speaking/teaching arrangements: Merck (B), Takeda (B); Scientific Advisory Board: Pfizer (B); research support (investigator salary): Roche (B); Grants: National Institute on Aging (B). TAG: royalties: MSD (F); fellowship support: Synthes (F), Stryker (F), Abbot (F), MSD (F). EET: royalties: Medtronic (F); consulting: Medtronic (F); speaking/teaching arrangements: Stryker (B); trips/travel: Medtronic (A); Scientific Advisory Board: United Health Care (B); fellowship support: Medtronic (E, paid to institution/employer), Synthes Spine (E, paid to institution/employer), Zimmer Spine (C, paid to institution/employer)
Funding source: Medtronic; Synthes Spine; Zimmer Spine
Other: Information modified for author contact |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Restricted randomisation using a 1:1:1 allocation ratio was applied using four strata. |
| Allocation concealment (selection bias) |
Low risk |
Before the trial, the project statistician generated a randomisation list using randomly mixed permuted blocks of different sizes. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
The active interventions used in this trial made blinding patients and providers to treatment type impossible. |
| Blinding of care provider (performance bias) |
High risk |
The active interventions used in this trial made blinding patients and providers to treatment type impossible. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Objective outcome assessment was performed by examiners masked to treatment allocation. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Overall attrition rate was 19%, with no differences among treatment groups |
| Participants analysed in group allocated (attrition bias) |
Low risk |
All analyses used the intention‐to‐treat principle. |
| Selective reporting (reporting bias) |
Low risk |
Support for judgement was not available. |
| Groups similar at baseline (selection bias) |
Low risk |
Randomisation resulted in three groups comparable on most baseline variables. |
| Co‐interventions avoided or similar (performance bias) |
Low risk |
Author response ‐ documented care provided to ensure it met protocol |
| Compliance acceptable in all groups (performance bias) |
Low risk |
Overall, adherence to study interventions was high with 96% of the spinal manipulative therapy group, 86% of the supervised exercise therapy group, and 96% of the home exercise and advice group. |
| Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
Support for judgement was not available. |
