| Study characteristics |
| Methods |
Study design: RCT
Setting: India, healthcare
Exercise groups: 1
Comparison groups: 1 |
| Participants |
Number of participants: 128 (E1 = 64, C1 = 64)
Chronic LBP duration: 41.58 months (long)
Neurological/radicular symptoms: No participants
Mean age (years): 41
Sex (female): 50% |
| Interventions |
Exercise Group 1 (E1): McKenzie exercise programme with no reported modifications; type = McKenzie; duration = 8 weeks; dose = high; design = standardised; delivery = individual; additional intervention = none
Comparison Group 1 (C1): Other conservative treatment (physical therapy) |
| Outcomes |
Core outcomes reported: Pain (Numerical Rating Scale); function (Roland‐Morris Disability Questionnaire); Global Perceived Health or Recovery (Global Perceived Health or Recovery (Global Rating of Change Scale))
Follow‐up time periods available for syntheses: 8 weeks (short) |
| Notes |
Conflicts of interest: None to declare
Funding source: Hajee A.M. Lockhat & Dr. A.M. Moolla Sarvajanik Hospital, Rampura, Surat
Other: Information modified for author contact |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Method of randomisation was described as a "lottery", which if carried out correctly, would adequately randomise participants. |
| Allocation concealment (selection bias) |
High risk |
No information reported as to whether or not treatment allocation was concealed adequately |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
1. Unlikely that patients could be kept blinded to their allocation, given how different the two treatment groups were; 2. Despite the treatment groups being so different, patients likely couldn't have effected a change in intervention protocol, as the interventions depended heavily on facilitation by trained personnel. |
| Blinding of care provider (performance bias) |
Low risk |
1. Care providers (physiotherapist) could not have been blinded because they delivered either the McKenzie programme or the conventional physiotherapy programme; 2. Explicit set of exercises in protocol |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
1. Outcome assessors for pain and disability were the patients, and thus were likely not able to be blinded to their intervention allocation; 2. Pain and functional questionnaires are subjective, and responses could be altered by awareness of intervention; 3. Mackenzie is tailored and sounds much better than "conventional" physiotherapy; likely altered expectations of effectiveness and assessment. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1. No description of dropout rate; 2. No evidence analysis corrected for missing data, no sensitivity analyses; 3. Increased low back pain or decreased function can cause missingness; 4. No information |
| Participants analysed in group allocated (attrition bias) |
Low risk |
1. Though not explicitly reported, it appeared that patients were analysed according to the treatment group to which they were allocated. |
| Selective reporting (reporting bias) |
Low risk |
1. No registered protocol, however all analysis described in the methods were reported. |
| Groups similar at baseline (selection bias) |
Low risk |
No significant differences in baseline age, sex, body mass index, pain duration, pain or disability; significantly more patients with central sensitization in experimental group |
| Co‐interventions avoided or similar (performance bias) |
Low risk |
Study exclusion criteria explicitly excluded patients who were receiving conflicting or ongoing co‐interventions (though not specified what counted as a co‐intervention). |
| Compliance acceptable in all groups (performance bias) |
Low risk |
Compliance (attendance) was not reported in the study, and so not able to determine exact compliance. |
| Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
1. Within each outcome, assessments were performed with identical tools and at the same time points; 2. Numeric Pain Rating Scale (for pain) and Roland‐Morris Disability Questionnaire (for disability) are well‐validated tools in the low back pain context. |
| Other bias |
Low risk |
Appeared free from other sources of bias |
