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11 February 2012
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| [ Print-friendly version ] |
| Function After Spinal Treatment, Exercise and Rehabilitation: Improving the functional outcome of spinal surgery |
| ISRCTN | ISRCTN46782945 |
| ClinicalTrials.gov identifier | |
| Public title | Function After Spinal Treatment, Exercise and Rehabilitation: Improving the functional outcome of spinal surgery |
| Scientific title | |
| Acronym | FASTER |
| Serial number at source | M0671 |
| Study hypothesis |
Added as of 26/06/2008:
The primary aim of this study is to determine if the long-term functional outcome of spinal surgery and patient satisfaction can be improved via either a systematic programme of post-operative rehabilitation or an educational booklet, and whether a combination of both is even more effective. The chief secondary objective is to assess whether such approaches are cost-effective. Please note that as of 26/06/2008, the trial information held in this record was updated, and information was added to fields previously empty. Details of all these additions and corrections can be found in the relevant field, under the update date of 26/06/2008. Please also note that as of 26/06/2008 the anticipated end date of this trial was extended as the trial was still actively recruiting. The previous anticipated end date of this trial was 30/04/2008. |
| Lay summary | |
| Ethics approval |
Added as of 26/06/2008:
Ethics approval received from the Hammersmith & Queen Charlotte’s & Chelsea Research Ethics Committee (ref: 04/Q0406/49). |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Spinal lateral root stenosis and discectomy |
| Participants - inclusion criteria |
Current inclusion criteria as of 26/06/2008:
Eligible patients at participating hospitals are those currently on the waiting list for spinal surgery with either: 1. Signs, symptoms and radiological evidence of lateral nerve root compression, that is, patients presenting with radicular pain with an associated neurological deficit or with neurogenic claudication (pain in the buttock, thigh or leg that improves with rest), or 2. Lumbar disc prolapse, that is, patients with root symptoms and signs and magnetic resonance imaging (MRI) confirmation of lumbar disc herniation Previous inclusion criteria: People with low back and leg pain |
| Participants - exclusion criteria |
Added as of 26/06/2008:
1. Any condition where either the intervention or the rehabilitation may have an adverse effect on the individual 2. Previous spinal surgery 3. Spinal surgery where a fusion procedure is planned due to the unknown hazards of the activity programme for this type of surgery 4. Pregnant women 5. Inadequate ability to complete the trial assessment forms 6. Any patient who is unable to attend the rehabilitation or the reviews or who is unsuitable for rehabilitation classes 7. Unable to complete outcome measures |
| Anticipated start date | 01/04/2005 |
| Anticipated end date | 01/03/2010 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 344 |
| Interventions |
Current interventions as of 26/06/2008:
Rehabilitation Programme: Patients randomised to the rehabilitation arms of the study will commence the programme 6 to 8 weeks following surgery. The programme will run for 6 weeks with subjects attending for 1 hour twice a week. Classes will be held first thing in the morning or at the end of the working day to accommodate, where possible, those who have returned to work. The classes will be run by an experienced physiotherapist, who will encourage patients individually to progress at their own pace. This structure allows new patients to join the programme at any time rather than in ‘batches’. There will be a maximum of ten patients per class. As previously stated, attempts will be made to keep the patients randomised to the rehabilitation-only group in separate classes from those randomised to the rehabilitation-plus-booklet group. Educational Booklet: Therefore a ‘post-operative back book’ that has been developed, will be provided to those patients allocated to either the booklet-only group or the rehabilitation-plus-booklet group at discharge from hospital following their surgery. This resource was constructed with the aim of developing a patient centred, evidence-based booklet that spinal surgeons may give to their patients to reduce uncertainty and facilitate post-surgical management and recovery. The booklet thus aims to provide carefully selected messages that will lead to a positive shift in beliefs and behaviours concerning pain, rehabilitation and self-management during the post-surgical period. Usual care: Patients randomised to the usual care control group will be managed routinely in the post-operative period, according to the relevant surgeon’s usual practice. This is likely to consist of a follow-up outpatient appointment some weeks after surgery plus general advice about progressively increasing the range and demands of physical activity, but no systematic programme of assessment and rehabilitation. The post-operative regimes of each surgeon will be quantified to define the usual post-operative care strategy and patients will be questioned via a self-completed questionnaire regarding any interventions or advice sought. Previous interventions: Post-operative rehabilitation programme versus usual post-operative review by the operating surgeon at 6 weeks. |
| Primary outcome measure(s) |
Added as of 26/06/2008:
Oswestry Disability Index. |
| Secondary outcome measure(s) |
Added as of 26/06/2008:
1. An economic analysis based on costs and EQ-5D (a validated, global measure of quality of life) 2. Visual analogue scales of back and leg pain 3. Measures of patient expectations and satisfaction 4. Return to work 5. Frequency of re-operation 6. Hospital Anxiety and Depression Scale (HADS) 7. Physical activity scale of the Fear Avoidance Beliefs Questionnaire |
| Sources of funding | Arthritis Research Campaign (ARC) (UK) (ref: M0671) |
| Trial website | |
| Publications | |
| Contact name | Dr Alison Hazel McGregor |
| Address |
Musculoskeletal Surgery
Imperial College London Charing Cross Campus |
| City/town | London |
| Zip/Postcode | W6 8RF |
| Country | United Kingdom |
| Sponsor | Arthritis Research Campaign (ARC) (UK) |
| Address |
Copeman House
St Mary's Court St Mary's Gate Chesterfield |
| City/town | Derby |
| Zip/Postcode | S41 7TD |
| Country | United Kingdom |
| Tel | +44 (0)1246 558033 |
| Fax | +44 (0)1246 558007 |
| info@arc.org.uk | |
| Sponsor website: | http://www.arc.org.uk/ |
| Date applied | 26/08/2004 |
| Last edited | 26/06/2008 |
| Date ISRCTN assigned | 21/01/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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