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Multi-centred Randomised Controlled Trial of Advice versus Physiotherapy for Low Back Pain Trial methods and lessons learnt S E Lamb Coventry University H Frost Queen Margaret University College, Edinburgh T Carver Nuffield Orthopaedic Centre, Oxford S Stewart-Brown Oxford University Clinical guidelines suggest that advice to remain active should be the primary intervention in low back pain. We have completed a multi-centred randomised trial comparing the clinical and cost effectiveness of physiotherapy versus advice only. Physiotherapy was standardised, and provided up to six treatments of mobilisation, manipulation or exercise, at the therapist’s discretion, but no electrotherapy or traction. Both groups received advice and The Back Book (Roland et al, 1997). Validated disease specific and generic outcomes were collected at baseline, 8, 36, and 52 weeks. A blinded data analysis is currently being undertaken. Methodological difficulties included slow recruitment, taking three years to recruit 287 patients. The trial uptake was approximately 50%, and using the design and costing model adopted, recruitment rates were determined by the capacity of National Health Service departments to treat patients. High staff turnover and vacancies were problematic. The highly transient population of Oxford
complicated follow-up, which was 82%, 67% and 70% at eight weeks, six months and 12 months respectively. This required the development of an intensive tracking and follow-up system. We used pre-defined criteria to identify the target population (mean age 41 years (SD 14.2) 53% women, 47% men). Over 90% were referred from general practitioners. The median duration of symptoms was more than six but less than 12 months. Low back and buttock pain were the most commonly reported symptoms, and 27% of people reported sensory symptoms in the leg. Half of them had sought treatment previously, most often from a general practitioner. The profile of baseline scores suggested pain to be the primary concern. Disability severity was low, but all participants reported some disability. In the physiotherapy group, exercise and mobilisation were the most commonly used treatments. Challenges in analysis will be developing methods to enable a full intention-to-treat analysis. The validity of secondary analysis to suggest successful treatment combinations is considered. Acknowledgement The Arthritis Research Campaign funded this study. H F is the principal investigator. Reference Roland, M, Waddell, G, Klaber-Moffett, J, Burton, K, Main, C and Cantrell, E (1997). The Back Book, The Stationery Office Ltd, Norwich.
Efficacy of Lumbar Traction in the Management of Low Back Pain Systematic review A Harte, G D Baxter, J H Gracey University of Ulster The Royal College of General Practitioners guidelines (Waddell et al, 1999) state that ‘traction does not appear to be effective for low back pain or radiculopathy’. These guidelines are based on the systematic review by van der Heijdan et al (1995) but he concluded that ‘due to the poor methodological quality of the studies, it is not possible to formulate a strong and valid judgement about lumbar traction’. Hence controversy continues. This review included only papers published up to 1992, underscoring the need for a new review focusing on the efficacy of traction in low back pain. A computer-aided search of Medline, Cinahl, AMED and the Cochrane Collaboration was conducted for randomised controlled trials in the English language, 1966-2001. The key words were back pain, traction, lumbar traction, autotraction, manual traction, gravitational traction,
physiotherapy, physical therapy, randomised trial, clinical trial. Key words were combined. Scores were assigned for quality of methods (based on patient selection, interventions, outcomes and statistics) as recommended by the Cochrane Back Review Group. Stage 2 of the review included the setting of criteria for adequate treatment procedures and doses (weights, duration and frequency of traction), as inadequacies in these areas may lead to serious performance bias. The review included 13 papers, nine studies from the original review and four new papers. One paper scored 9 points (maximum score 10 points) the other 12 papers scored between 0-3 points, indicating that most were of poor quality. Nine studies reported negative findings but only one of these was of a high quality. Three studies reported positive findings and one study was inconclusive. In stage 2 of the review only four trials, all of low Physiotherapy July 2002/vol 88/no 7
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methodological quality, were included: two studies reported negative and two positive findings. In conclusion, despite the addition of four new trials, the evidence for the use of traction in low back pain remains inconclusive. This is due to the continued lack of methodological rigour and to limited application of clinical parameters as used in clinical practice. Further trials which give attention to these areas are needed before any firm conclusions and recommendations may be made.
References van der Heijdan, G J M G, Beurskens, A J H M, Koes, B W, Assendelft, W J J, de Vet, H C W and Bouter, L M (1995). ‘The efficacy of traction for back and neck pain: A systematic, blinded review of randomised clinical trial methods’, Physical Therapy, 75, 93-104. Waddell, G, McIntosh, A, Hutchinson, A, Feder, G and Lewis, M (1999). Low Back Pain Evidence Review, Royal College of General Practitioners, London.
Randomised Controlled Trial of Physiotherapy in the Early Period after Arthroscopic Partial Meniscectomy P C Goodwin, M C Morrissey, M A Klarneta, D Morrissey King’s College London
occurred at five and fifty days after surgery. The major outcome measures were:
J Ratcliffe Research Triangle Institute, Manchester
■ Hughston Clinic self-assessed knee questionnaire. ■ SF-36 and EuroQol quality of life questionnaires.
R Omar University College London J B King Royal London Hospital T B McAuliffe, P Knight, M Brown Whipps Cross University Hospital, London K Southall Holly House Hospital, Buckhurst Hill, Essex Introduction Knee arthroscopic partial meniscectomy often leads to knee pain and muscle weakness (Matthews and St Pierre, 1996) leading to decreased function (Durand et al, 1993) and possibly decreased quality of life. Despite this knowledge, whether or not to use rehabilitation is not consistent among National Health Service or private hospitals. Few studies have looked at the possible benefits of an intensive course of outpatient physiotherapy immediately after this surgery. Our aim is to present the results of a randomised controlled trial examining the benefits of early intensive physiotherapy following this very common type of surgery.
■ Number of days taken to return to work after surgery. ■ Factor Occupational Rating System (FORS) assessment of stressfulness of work to the knee. ■ Kinematic analysis of knee function during level walking and stair use. ■ Horizontal and vertical single-leg jumps. Between tests, subjects trained in either formal physical therapy sessions or in an unsupervised home exercise programme. Regression analyses were per formed to examine differences in outcomes in the two groups. Results No significant differences (p > 0.05) between the intervention and control groups were found for the: Hughston Clinic score, SF-36 score, EuroQol score, number of days taken to return to work after surgery divided by the FORS score, knee sagittal plane kinematic function during stance phase whilst ascending stairs, and injured /uninjured vertical jump ratio. Conclusions Formal physiotherapy as used in this study is not indicated for patients in the early period after uncomplicated arthroscopic partial meniscectomy surgery. Acknowledgement
Subjects Eighty-six patients recovering from knee arthroscopic partial meniscectomy surgery (74 men, 12 women; ages 18 to 60, mean 38 years) were included. Subjects underwent an uncomplicated arthroscopic partial meniscectomy. Subjects were excluded if they had any other current injuries to their contralateral lower limb that required medical attention, or any neural disorders affecting their lower limbs, or were expecting surgery within six months following their arthroscopy.
Matthews, P and St Pierre, D M M (1996). ‘Recovery of muscle strength following arthroscopic meniscectomy’, Journal of Orthopaedic Sports Physical Therapy, 23, 18-26.
Method This study was approved by the East London and City Health Authority Ethics Committee. Test sessions
Durand, A, Richards, C L, Moulin, F and Bravo, G (1993). ‘Motor recovery after arthroscopic partial meniscectomy’, Journal of Bone and Joint Surgery, 75-A, 202-214.
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The authors acknowledge grant support from the National Health Service Executive, London Regional Office, Responsive Funding Programme. References