Study characteristics |
Methods |
Study design: RCT (IRCT2013121615822N1)
Setting: Iran, healthcare
Exercise groups: 2
Comparison groups: 0 |
Participants |
Number of participants: 32 (E1 = 16, E2 = 16)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: Not specified
Mean age (years): 36
Sex (female): Not reported |
Interventions |
Exercise Group 1 (E1): Stabilisation exercises: co‐ordinated training and independent activity of deep trunk muscles including transversus abdominis and multifidus in pain‐free positions and movements, also done at home; type = core strengthening; duration = 4 weeks; dose = low; design = partially individualised; delivery = individual; additional intervention = none
Exercise Group 2 (E2): Movement control exercises: dissociation of lumbo‐pelvic movement from thoracic movement in order to reduce excessive lumbar extension, training to perform everyday and work tasks without abnormal bracing or breathing, daily exercises at home; type = functional restoration; duration = 4 weeks; dose = low; design = partially individualised; delivery = individual; additional intervention = none |
Outcomes |
Core outcomes reported: Pain (Numerical Rating Scale); function (Oswestry Disability Index)
Follow‐up time periods available for syntheses: 4 weeks (short) |
Notes |
Conflicts of interest: Not reported
Funding source: Rehabilitation School, Tehran University of Medical Sciences
Other: None |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Randomisation method was not described enough to make an assessment of adequacy; only description was that randomisation was achieved "via a random number sequence". |
Allocation concealment (selection bias) |
High risk |
Not enough information on the randomisation and treatment allocation methods to assess |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
1. Patients were not blind to intervention because the interventions were too different for patients not to know the difference, however the team "Attempt[ed] to keep subjects blind to their group assignment"; 2. Both groups getting sufficient treatment, unlikely to be dissatisfied; difficult to access outside of study context |
Blinding of care provider (performance bias) |
Low risk |
1. "The treating therapist was not blind to the treatment group of the subjects" (treating therapist = care providers); 2. Explicit set of exercises in protocol; no decision by care provider; since there wasn't a favoured intervention prior, unlikely that providers tried to "balance" care |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
1. Outcome assessors were the patients for outcomes pain and disability, they were not blinded; 2. Pain and functional questionnaires are subjective, and responses could be altered by awareness of intervention; 3. Because there was no clear "better" intervention between the two, it is unlikely that the lack of patient blinding led to a serious biasing of judgement for outcome assessment. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1. Dropout rate (25%) was borderline unacceptable for a short‐term follow‐up (four weeks); 2. Evidence that the analysis was not biased by missing data: the dropout rate was identical for both treatment groups, and dropout reasons were unrelated to low back pain. |
Participants analysed in group allocated (attrition bias) |
Low risk |
1. Intention‐to‐treat analysis was included; all patients were analysed according to the treatment to which they were randomised. |
Selective reporting (reporting bias) |
Low risk |
1. No linked protocol found but within this paper all outcomes and analyses fully reported; no obvious omissions |
Groups similar at baseline (selection bias) |
Low risk |
Groups were similar at baseline on age, body mass index, pain and disability, but did not report sex or duration of back pain symptoms at baseline. |
Co‐interventions avoided or similar (performance bias) |
High risk |
No information on how the study dealt with co‐interventions (or if they existed) was reported. |
Compliance acceptable in all groups (performance bias) |
High risk |
Compliance was not reported, so it was difficult to assess its acceptability; intervention was supervised, which tends to increase compliance. |
Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
1. All outcome assessments were similarly timed and measured for all treatment groups; 2. Numeric Rating Scale (for pain) and Oswestry Disability Index (for disability) are well‐validated tools in the low back pain field. |
Other bias |
Low risk |
Appeared free from other sources of bias |