Macedo 2012.
| Methods | Randomised controlled trial | |
| Participants | 172 participants (86 motor control, 86 graded activity). Participants were recruited to the trial by general practitioners in Sydney and Brisbane or drawn from the waiting list of an outpatient physical therapy department from a public hospital in Sydney. Inclusion criteria: chronic non‐specific low back pain (> 3 months duration) with or without leg pain, currently seeking care for low back pain, between 18 and 80 years of age, English speaker (to allow response to the questionnaires and communication with the physical therapist), clinical assessment indicated that the patient was suitable for active exercises expected to continue residing in the Sydney or Brisbane region for the study duration, had a score of moderate or greater on question 7 ("How much bodily pain have you had during the past week?") or question 8 ("During the past week, how much did pain interfere with your normal work, including both work outside the home and housework?") of the 36‐Item Short‐Form Health Survey questionnaire (SF‐36). Exclusion criteria: known or suspected serious pathology such as nerve root compromise (at least 2 of the following signs: weakness, reflex changes or sensation loss, associated with the same spinal nerve), previous spinal surgery or scheduled for surgery during trial period, comorbid health conditions that would prevent active participation in exercise programmes. They used a "red flag" checklist to screen for serious pathology and the Physical Activity Readiness Questionnaire from the American College of Sports Medicine guidelines to screen for comorbid health conditions that would prevent safe participation in exercise. |
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| Interventions | Participants in each group were to receive 14 individually supervised sessions of approximately 1 hour. The treatment consisted of 12 initial treatment sessions over an 8‐week period and 2 booster sessions at 4 and 10 months following randomisation. The initial 12 sessions were conducted twice a week for the first 4 weeks and once a week for the following 4 weeks. The treatment sessions were designed to become less frequent and promote independence. In order to facilitate adherence to treatment sessions and to be consistent with clinical practice, if patients could not complete the initial 12 treatment sessions within the first 8 weeks, they received an extension of another 4 weeks to complete the 12 treatment sessions. Patients included in both exercise programmes were advised to do home exercises for at least half an hour per week in the first month and 1 hour per week in the 2nd month. The type of home exercises, intensity and number of sessions per day were at the discretion of the physical therapist. Trial interventions were provided by 10 physical therapists with at least 2 years of clinical experience who received training in motor control exercises and graded activity. Therefore, all therapists provided both interventions. The training included a 2‐day workshop for the motor control exercises and a series of evening interactive seminars for graded activity, both administered by recognised experts in the field. The same experts performed audits of trial treatment of most of the treating physical therapists to evaluate and encourage compliance with the treatment protocols. Although they did not have the specific data necessary to evaluate the physical therapists' compliance with the treatment protocols, their audits revealed that most physical therapists followed the treatment protocols and there was no evidence of cross‐contamination. The physical therapists worked at private clinical practices or at the university clinic. Motor control: 14 sessions, 1 hour, 8 weeks (4 weeks ‐ 2 times per week/4 weeks ‐ once a week). A primary goal of the exercise was to enable the patient to regain control and co‐ordination of the spine and pelvis using principles of motor learning such as segmentation and simplification. The intervention was based on assessment of the individual participant's motor control impairments and treatment goals (set collaboratively with the therapist). The first stage of the treatment involved assessment of the postures, movement patterns and muscle activation associated with symptoms and implementation of a retraining programme designed to improve activity of muscles assessed to have poor control (commonly, but not limited to, the deeper muscles such as transversus abdominis, multifidus, pelvic floor and diaphragm) and reducing activity of any muscle identified to be overactive, commonly the large, more superficial trunk muscles such as the obliquus externus abdominis. Participants were taught how to contract trunk muscles in a specific manner and progress until they were able to maintain isolated contractions of the target muscles for 10 repetitions of 10 seconds each while maintaining normal respiration. Feedback such as palpation and real‐time ultrasound images were available to enhance learning of the tasks. During this stage, additional exercises for breathing control, posture of the spine, and lower limb and trunk movement were performed. The 2nd stage of the treatment involved the progression of the exercises toward more functional activities, first using static and then dynamic tasks. Throughout this process, the recruitment of the trunk muscles, posture, movement pattern and breathing were assessed and corrected. In contrast to the graded activity programme, motor control exercise was guided by pain, and exercises were mostly pain‐free. Graded activity: 14 sessions, 1 hour, 8 weeks (4 weeks ‐ 2 times per week/4 weeks ‐ once a week). A primary goal of the programme was to increase activity tolerance by performing individualised and submaximal exercises, in addition to ignoring illness behaviours and reinforcing wellness behaviours. The programme was based on activities that each participant identified as problematic and that he or she could not perform or had difficulty performing because of back pain. The activities in the programme were progressed in a time‐contingent manner (rather than a traditional pain‐contingent manner) from the baseline‐assessed ability to a target goal set jointly by participant and therapist. Participants received daily quotas and were instructed to only perform the agreed amount, not less or more, even when they felt they were capable of doing more. Cognitive‐behavioural principles were used to help the participants overcome the natural anxiety associated with pain and activities. The physical therapists used positive reinforcement, explained pain mechanisms, and addressed negative behaviours and pain‐related anxiety. A plan for managing relapses was developed by the therapists and participants. |
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| Outcomes | Pain (NRS 0 to 10) Function (Patient Specific Function Scale (PSFS)) Global Perceived Effect (GPES) Quality of life (SF‐36) Disability (Roland Morris Disability Questionnaire (RMDQ)) |
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| Notes | Clinical trial registration: ACTRN12607000432415 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The randomisation sequence was computer generated by an investigator not involved in recruitment or treatment allocation" |
| Allocation concealment (selection bias) | Low risk | "Allocation was concealed in sequentially numbered, sealed, opaque envelopes by an investigator not involved in the study" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded |
| Blinding of personnel/care provider (performance bias) All outcomes | High risk | "Clinicians could not be blinded to the interventions" |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Not considered as patients were not blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | The percentage of withdrawals and dropouts was within the acceptable rate |
| Intention‐to‐treat analysis | Low risk | "The statistical analyses were performed using SPSS version 16.0 for Windows (SPSS Inc, Chicago, Illinois) and STATA version 9.0 (Stata‐Corp LP, College Station, Texas) (linear mixed models) on an intention‐to‐treat basis" |
| Selective reporting (reporting bias) | Low risk | "This trial was prospectively registered (ACTRN12607000432415), and the protocol has previously been published" |
| Group similarity at baseline (selection bias) | Low risk | Patients did not differ in their baseline characteristics |
| Co‐interventions (performance bias) | High risk | "Ten, five, and eight participants in the graded activity group and 6, 17, and 9 participants in the motor control exercise group reported receiving co‐interventions in addition to the trial treatment at the 2‐, 6‐, and 12‐month follow‐ups, respectively" |
| 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 |