Study characteristics |
Methods |
Study design: RCT (DRKS00000373)
Setting: Germany, general population
Exercise groups: 1
Comparison groups: 1 |
Participants |
Number of participants: 68 (E1 = 36, C1 = 32)
Chronic LBP duration: 11.5 years (long)
Neurological/radicular symptoms: Not specified
Mean age (years): 55
Sex (female): 76% |
Interventions |
Exercise Group 1 (E1): Home‐based exercise programme: booklet containing education on low back pain and exercises that focussed on stretching, strengthening, and joint mobilisation exercises; type = mixed; duration = 8 weeks; dose = low; design = standardised; delivery = independent; additional intervention = advice/education
Comparison Group 1 (C1): Other conservative treatment (relaxation) |
Outcomes |
Core outcomes reported: Pain (Visual Analogue Scale); function (Roland‐Morris Disability Questionnaire); HRQoL (36‐Item Short Form Survey)
Follow‐up time periods available for syntheses: 8 weeks (short) |
Notes |
Conflicts of interest: None to declare
Funding source: Else KrönerFresenius‐Stiftung, Germany
Other: None |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Randomisation was based on the “ranuni” pseudo‐random number generator of the SAS/Base statistical software, using a nonstratified block‐randomisation with varying block lengths method. |
Allocation concealment (selection bias) |
Low risk |
Patients were randomly allocated to a treatment group by preparing sealed, sequentially numbered opaque envelopes containing the treatment assignments; envelopes were prepared by study biostatistician. |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
1. Patients could not be blinded to the intervention due to the nature of the treatment groups; 2. Unlikely that knowledge of the meditation intervention would have significantly altered the way participants in the take‐home exercise group performed the 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 deviations from protocols; meditation was practiced in a standard way, and independent exercise group only saw physician once at the start of study. |
Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
1. Outcome assessors for outcomes of interest (pain and disability) were participants, who could not be blinded due to the nature of the interventions; 2. Pain and functional questionnaires are subjective, and responses could be altered by awareness of intervention; 3. Possible that either intervention could be considered better with no clear bias in a particular direction |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
1. 16 out of 68 total randomised participants (23.5%) dropped out of the study 2. Dropout rates between treatment groups were not equal, which indicates that there may have been bias in missingness of data between treatment groups; 3. Possible that participants who saw no improvement or worsening of symptoms were more likely to drop out; missingness of outcomes could have been more likely for poorer outcome results; 4. Missingness rates between treatment groups were not equal; 37.5% missing from meditation group, 11% missing from exercise group; 5. Likely that participants who saw no improvement or worsening of symptoms dropped out. Thus, worse outcome results were missing, biasing meditation group to appear better than it truly was. |
Participants analysed in group allocated (attrition bias) |
Low risk |
1. All outcome criteria were analysed by intention‐to‐treat, including all randomised subjects, irrespective of whether or not they adhered to the protocol, or gave a full set of data. |
Selective reporting (reporting bias) |
Low risk |
1. All analyses conducted and reported as described, except global rating of effectiveness, which was only briefly reported in discussion for one treatment group |
Groups similar at baseline (selection bias) |
Low risk |
All relevant baseline characteristics were measured and similar between treatment groups, except there was a higher proportion of females in the meditation group. |
Co‐interventions avoided or similar (performance bias) |
High risk |
Regular analgesic medication should not have been changed in 6 weeks before study start; rescue medication was allowed; use was reduced in 5 subjects of the mediation group and none of exercise group. |
Compliance acceptable in all groups (performance bias) |
High risk |
Study reported "non‐compliance" among some individuals, but none of these individuals completed a post‐intervention assessment, so we considered them dropouts; no other information reported |
Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
1. All participants had outcome assessments at the same time points, and for each outcome; were assessed using the same tools; 2. Visual Analogue Scale (for pain) and Roland‐Morris Disability Questionnaire (for disability) are well‐validated tools in the context of low back pain. |
Other bias |
Low risk |
Appeared free from other sources of bias |