Koumantakis 2005.
| Methods | Randomised controlled trial | |
| Participants | 55 participants (29 stabilisation + general exercise, 26 general exercise). Patients were recruited from the orthopaedic clinic of a local hospital and several general practitioners' practices. Patients took part in the study after informed consent had been obtained. The rights of human participants were protected at all times. Inclusion criteria: patients were eligible for the study if they had a history of recurrent LBP (repeated episodes of pain in past year collectively lasting for less than 6 months) of a non‐specific nature, defined as back pain complaints occurring without identifiable specific anatomical or neuro‐physiological causative factors. To establish this, all patients included in the trial had a prior clinical examination by their physician, including a radiograph or a magnetic resonance imaging scan. Exclusion criteria: patients with previous spinal surgery, "red flags" (i.e. serious spinal pathology or nerve root pain signs) as outlined in the Clinical Standards Advisory Group (CSAG) report for back pain, or signs and symptoms of instability (radiological diagnosis of spondylolysis or spondylolisthesis corresponding to a symptomatic spinal level; "catching", "locking", "giving way" or "a feeling of instability" in one direction or multiple directions of spinal movements) were excluded. |
|
| Interventions | The same frequency (twice per week), programme duration (8 weeks) and class duration (45 to 60 minutes per session) were provided for both groups. All participants received an information booklet (The Back Book) providing the latest scientific facts on LBP management at the beginning of the programme. The main aim of this booklet is to change patient beliefs and behaviours regarding back pain. The clinical physical therapist who administered the exercise sessions monitored class adherence, and participants were required to keep an exercise diary monitoring home adherence. The number of sessions in class environment and at home was recorded. Stabilisation + general exercise: 8 weeks, 2 times per week, 45 to 60 minutes per session. Briefly, low‐load activation of the local stabilising muscles was initially administered, with no movement (isometric) and in minimally loaded positions (4‐point kneeling, supine lying, sitting, standing). Progressively, the holding time and then the number of contractions were increased in those positions up to 10 contraction repetitions,10‐second duration each (weeks 1 and 2). The clinical measure used to ensure correct activation of the transversus abdominis muscle was to observe a slight drawing‐in manoeuvre of the lower part of the anterior abdominal wall below the umbilical level, consistent with the action of this muscle. In addition, a bulging action of the multifidus muscle should have been felt under the clinical physical therapist's fingers when they were placed on either side of the spinous processes of the L4 and L5 vertebral levels, directly over the belly of this muscle. Various facilitation techniques were used throughout the programme to draw participants' attention to the specific nature of the desired muscle contractions (tactile and pressure cues over areas of the specific muscles, auditory cues to enhance their contraction, use of contraction of the pelvic‐floor muscles). Furthermore, participants were made aware of and were told to avoid several incorrect muscle activation ("substitution") strategies, where a movement muscle takes over the control of movement from the stabilising muscles (too much effort causing unwanted spasms in the movement muscles or spinal movement at the initial stages were discouraged). Integration with dynamic function (activities that required spinal or limb movements) through incorporation of the stabilising muscles' co‐contraction into light functional tasks was advised as soon as (1) the specific pattern of co‐activation was achieved in the minimally loading positions and (2) the participants could comfortably perform 10 contraction repetitions x 10 seconds duration each (weeks 3 to 5). Heavier‐load functional tasks, with exercises similar to those performed by the participants who performed general exercise only, were progressively introduced in the last 3 weeks of the programme. General exercise: 8 weeks, 2 times per week, 45 to 60 minutes per session. For the participants who performed general exercise only, exercises activating the extensor (paraspinals) and flexor (abdominals) muscle groups were administered. Muscle contraction occurring with exercise imposes extra loading on the spinal tissues, therefore the general exercises were selected on the basis of maximising the contraction benefit/spinal loading ratio, according to recommendations provided from recent experimental studies. |
|
| Outcomes | Pain (NRS 0 to 10) Disability (Roland Morris Disability Questionnaire (RMDQ)) |
|
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Following completion of all pre‐intervention assessments, subjects were randomly assigned to 1 of the 2 intervention groups via a computer generated random number sequence" |
| Allocation concealment (selection bias) | Low risk | "Randomisation codes were kept in sealed envelopes with consecutive numbering" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No mention of any attempts to blind the participants |
| Blinding of personnel/care provider (performance bias) All outcomes | High risk | No mention of any attempts to blind the care provider |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | No mention of any attempts to blind the assessor |
| Incomplete outcome data (attrition bias) All outcomes | High risk | "From the 55 randomly assigned subjects, 10 dropped out of the program (n=5 per group)..." |
| Intention‐to‐treat analysis | Low risk | "All analyses were performed primarily according to the "intention‐to‐treat" (ITT) principle, with all subjects randomly assigned for intervention analysed in their assigned groups" |
| Selective reporting (reporting bias) | Low risk | No protocol or trial registration, but it was clear that the published report included all expected outcomes |
| Group similarity at baseline (selection bias) | Low risk | Patients did not differ in their baseline characteristics |
| Co‐interventions (performance bias) | Unclear risk | Not described |
| Compliance (performance bias) | Low risk | Compliance was considered similar for both groups |
| Timing of outcome assessment (detection bias) | Low risk | All important outcome assessments for both groups were measured at the same time |