Study characteristics |
Methods |
Study design: RCT (NCT02178202)
Setting: Iran, healthcare
Exercise groups: 2
Comparison groups: 0 |
Participants |
Number of participants: 14 (E1 = 7, E2 = 7)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: No participants
Mean age (years): 37
Sex (female): 43% |
Interventions |
Exercise Group 1 (E1): Harmonic mobilisation technique: lower limb lifted by sling, patients asked to move leg side to side; type = flexibility/mobilising; duration = 2 weeks; dose = low; design = partially individualised; delivery = individual; additional intervention = none
Exercise Group 2 (E2): End range loading, back extensions; type = core strengthening; duration = 2 weeks; dose = low; design = standardised; delivery = individual; additional intervention = none |
Outcomes |
Core outcomes reported: Pain (Numerical Rating Scale); function (Roland‐Morris Disability Questionnaire)
Follow‐up time periods available for syntheses: 2 weeks (short) |
Notes |
Conflicts of interest: None to declare
Funding source: No funding received
Other: Information modified for author contact |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Used "the blocked randomization method (based on sample size in each group)" |
Allocation concealment (selection bias) |
High risk |
No information on treatment allocation concealment |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
1. Patients could not be blinded to allocation due to the nature of the treatments; 2. Unlikely that lack of patient blinding caused deviation from intended interventions because patients had no control over the delivery of intervention. |
Blinding of care provider (performance bias) |
Low risk |
1. Care providers could not be blinded to allocation due to the nature of the treatments; 2. Unlikely that lack of care provider blinding led to deviation from intended intervention because interventions were quite distinct and clearly prescribed. |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
1. Outcome assessors for pain were the patients themselves, who could not be blinded due to the nature of the treatments; 2. Pain and function questionnaires are subjective and can be altered by knowledge of intervention; 3. No clear better intervention, both groups receiving active treatment, no reason to alter patient response. |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
1. No description of dropout rate; 2. Analysis did not account for missing data; no sensitivity analysis; 3. Increased pain and function could cause missingness; 4. No indication of missing values; 5. No indication of missing values |
Participants analysed in group allocated (attrition bias) |
Low risk |
1. Appeared that all patients were analysed according to the allocation to which they were randomised |
Selective reporting (reporting bias) |
Low risk |
1. Study analysed and reported as described in methods section; protocol was registered (NCT02178202) but contained no pre‐planned outcomes. |
Groups similar at baseline (selection bias) |
Low risk |
Groups were similar on all relevant characteristics at baseline, except did not report duration of symptoms. |
Co‐interventions avoided or similar (performance bias) |
Low risk |
"To control the effects of other interventions, the patients were asked to abstain from exercise, medication use, and/or any type of modalities through the period of study". |
Compliance acceptable in all groups (performance bias) |
High risk |
No information on compliance |
Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
1. Outcome assessments were identical for all patients, regardless of treatment group; 2. Numeric Rating Scale (for pain) and Roland‐Morris Disability Questionnaire (for function) are well‐validated tools in the low back pain context. |
Other bias |
Low risk |
Appeared free from other sources of bias |