Study characteristics |
Methods |
Study design: RCT
Setting: Germany, general population
Exercise groups: 1
Comparison groups: 1 |
Participants |
Number of participants: 45 (E1 = 24, C1 = 21)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: No participants
Mean age (years): 32
Sex (female): 42% |
Interventions |
Exercise Group 1 (E1): Seventy‐minute abdominal perturbation training as stabilisation exercises with 10 minutes whole body exercises and 10 minutes cool down exercises; type = core strengthening; duration = 13 weeks; dose = high; design = partially individualised; delivery = individual; additional intervention = none
Comparison Group 1 (C1): Usual care/no treatment (control group: no intervention) |
Outcomes |
Core outcomes reported: Pain (Visual Analogue Scale); function (Low Back Pain Rating Scale)
Follow‐up time periods available for syntheses: 13 weeks (moderate) |
Notes |
Conflicts of interest: None to declare
Funding source: German Federal Institute of Sport Science; MiSpEx National Research Network for Medicine in Spine Exercise (Grant Number 080102A/11‐14)
Other: Information modified for author contact |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Block random‐number procedure |
Allocation concealment (selection bias) |
Low risk |
Treatment allocation was likely concealed; the randomisation procedure was controlled by a member of the same institution, who was not involved in the design and execution of the study. |
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. Exercise therapy required machinery that would not be accessible outside of study context. |
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. Therapists seemed to have had minimal contact with control group; exercise therapy so distinct and specific that no deviation could casually occur. |
Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
1. Outcome assessors in this study were the patients themselves, who could not be blinded due to the nature of the treatments; 2. Pain and functional questionnaires are subjective, and responses could be altered by awareness of intervention; 3. Likely that lack of patient blinding led to perception that experimental group was better than control, and so biased the outcome assessments accordingly; pain study results supported this. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1. 5 patients of 45 did not finish the study, 11%. |
Participants analysed in group allocated (attrition bias) |
Low risk |
1. Appeared that all patients were analysed according to the treatment group to which they were randomised |
Selective reporting (reporting bias) |
Low risk |
1. No linked protocol or statistical analysis plan found: within this paper all outcomes and analyses fully reported, functional status not measured, but isometric measurements likely took place. |
Groups similar at baseline (selection bias) |
Low risk |
Both treatment groups were similar at baseline on age, sex, pain, height and weight, but there was no reporting of duration of symptoms. |
Co‐interventions avoided or similar (performance bias) |
Low risk |
Co‐interventions were largely avoided, as the study excluded patients with continuous dependency on pain relief medication or physiotherapist treatment. |
Compliance acceptable in all groups (performance bias) |
Low risk |
No information on compliance/adherence/attendance to sessions was reported. |
Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
1. All outcome assessments were identical, regardless of treatment group; 2. Visual Analogue Scale (for pain) is a well‐validated tool in the low back pain context. |
Other bias |
Low risk |
Appeared free from other sources of bias |