Biggest ever low back pain trial finds non-surgical treatment is best
by University of Oxford
23 May 2005
The largest ever clinical trial of surgery versus exercise treatments for chronic low back pain has found that patients may obtain as much benefit from an intense exercise and therapy programme as from spinal surgery. The results of the nine-year MRC Spine Stabilisation Trial, led by Oxford, were just published online by the British Medical Journal. The study should help doctors make decisions about the management of back pain.
Chronic low back pain is one of the most common ailments that GPs and consultants treat. The condition is painful for patients and treatment is costly for the NHS and the UK economy: direct costs have been estimated at around £1.6 billion, and the condition is estimated to account for close to 120 million work days lost per year.
For nearly 90 years the same method of spinal surgery has been used to treat low back pain. There has, however, been little evidence to support the assumption that surgery is more effective than the best exercise treatments.
The trial, led by Jeremy Fairbank, Consultant Orthopaedic Surgeon at the Nuffield Orthopaedic Centre, involved 349 chronic back pain patients. 176 were assigned to spinal fusion surgery and 173 to a three-week intensive programme of rehabilitation, involving daily exercises and cognitive behavioural therapy. The rehabilition aimed not only to address physical aspects, but to help patients overcome fear of pain, overcome fear of exercise, learn to cope with the psychological effects of pain, and learn to relax.
There appeared to be a slight advantage to surgical treatment, but the difference only just reached the defined minimum level of clinical significance, and is outweighed by the financial costs. A concurrent study of the economics of the two treatment programmes, directed by Dr Alistair Gray of the Institute of Health Sciences, suggests that a strategy of intensive rehabilitation is half the price of a surgical strategy.
Mr Fairbank concluded: "There was no clear evidence from our trial that primary spinal fusion surgery was more beneficial than intensive rehabilitation. Our results suggest that patients eligible for surgery should be offered a rehabilitation programme first. We believe it is safer and cheaper than using surgery as the first line of treatment."
Trial: Jeremy Fairbank, Consultant Orthopaedic Surgeon, Nuffield, Orthopaedic Centre, Oxford, UK
Cost analysis: Helen Campbell, Research Officer, Health Economics Research Centre, Department of Public Health, University of Oxford, UK
Notes to Editors
- The full paper, "Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial" by Jeremy Fairbank, Helen Frost, James Wilson-MacDonald, Ly-Mee Yu, Karen Barker, and Rory Collins, can be read online at www.bmj.com. [A LINK TO ITS PDF VERSION IS AT THE END OF THIS PAGE]
- In the first instance, patients were given a questionnaire, The Oswestry Disability Index (ODI), designed to assess the limitations of various daily activities. They then undertook The Shuttle Walking Test (SWT), used to assess the physical abilities of the patient. The SWT is based on how long the patient can keep walking until pain or fatigue adjourns them or when the patient fails to complete the distance in the given time. The patients then had to complete two other questionnaires, The Short Form-36 General Health Questionnaire (SF-36) used as a general health questionnaire and The EuroQol (EQ-5D) which is divided into two sections is aimed at assessing mobility self-care, usual activity, pain/discomfort and anxiety/depression. The latter part assesses general health on a scale of 100 to 0; 100 being best imaginable health state and 0 worst imaginable health state. These questionnaires and assessment were used at regular intervals to a minimum of two years follow-up.
- The overall philosophy of the rehabilitation programme was to encourage patients to adopt an active and positive approach to their own treatment.
- The aims of the rehabilitation programme were: to decrease functional disability; to increase the patient?s confidence to carry out normal activities of daily living despite pain; to improve general health, to overcome fear of pain, to improve psychological well being; and to increase physical endurance.
- The rehabilitation programme consisted of a daily outpatient programme of education and exercise, running for 5 days over three weeks for approximately 6 hours per day. Patients were either treated as outpatients or stayed in bed and breakfast accommodation nearby to avoid hospital admission and long periods each day travelling. Each programme included 4-8 subjects depending on space and resources in each centre. Subjects spent at least 2 hours engaged in some form of activity and 3 hours in educational sessions each day. Most centres offered at least 75 hours' intervention (range 60-110 hours). Follow-up sessions were offered for one day only at 1, 3, 6 and 12 months after treatment. The aim of these sessions was to monitor progress and discuss setbacks or any problems that may have arisen.
- The rehabilitation programmes were led by physiotherapists, but included clinical psychologists and medical support. In four out of the 15 collaborating centres rehabilitation programmes were already established for more severely disabled patients and adapted for the trial patients. The remaining centres either set up a programme based on the trial protocol or referred to another centre with an established programme.
- Daily exercise was individually tailored to the patients' ability. The exercises consisted of stretching exercises, general muscle strengthening, spine stabilisation exercises aiming to exercise the deep abdominal muscles, endurance, and low impact aerobic exercise. All exercise was paced, setting baseline activities at 80 per cent less than the patient's pre-treatment scores, and progressed slowly to avoid over-activity. Exercise included step-ups, walking on a treadmill, cycling on a static ergometer, bridging, static and dynamic abdominal and extensor work, abdominal exercises using a gym ball, and upper limb strengthening. Spine stabilisation exercises were taught in all centres.
- All but one centre included daily sessions of hydrotherapy.
- The educational topics within the rehabilitation programme included: relaxation techniques; basic biomechanics of the spine; goal setting; activity pacing; importance of exercise and overcoming fear of exercise; ergonomics; understanding and coping with pain; the process of healing structures including joints and muscle; detrimental effects of rest and general deconditioning; set-back planning; maintenance of progress and stress management; and information regarding the physical, psychological and social impact of back pain on the individual.
- Individual sessions with the psychologist were scheduled for those who had particular psychological problems affecting their rehabilitation. Patients were given praise, encouragement and reinforcement to recognise their own achievements and work on their own personal goals and reinforcement. Cognitive behavioural principles were used to identify and overcome fears and unhelpful beliefs that many patients develop when in pain. Video recordings were made of patients in some centres carrying out normal activities of daily living to increase awareness of quality of movement and illness behaviour. Relaxation methods were practiced daily.
- Subjects were encouraged to continue all exercises and relaxation techniques at home.
For the original article click here...
Click here for the trial paper in PDF version