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13 May 2008
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| [ Print-friendly version ] |
| Effectiveness of a multidisciplinary intervention in subacute low back pain in the working population |
| ISRCTN | ISRCTN21392091 |
| ClinicalTrials.gov identifier | |
| Public title | Effectiveness of a multidisciplinary intervention in subacute low back pain in the working population |
| Scientific title | Effectiveness of a multidisciplinary intervention in the evolution of non-speficic subacute low back pain in the working population |
| Acronym | MILUPA |
| Serial number at source | 071610 |
| Study hypothesis |
1. A multidisciplinary intervention (including physical, psychological, educational and pharmacological aspects), reduces intensity of pain, improves functional status and quality of life and diminishes progression towards chronicity in patients with non-specific subacute low back pain, compared to standard clinical practice
2. The multidisciplinary approach manages to reduce both the period of sick leave and duration of pharmacological treatment, compared to standard clinical practice 3. Patient satisfaction is higher with the multidisciplinary approach than that obtained with standard clinical care 4. Differences exist among individual features of those patients that develop non-specific chronic low-back pain and of those who recover |
| Ethics approval | Research Ethics Committee of the Jordi Gol i Gurina Primary Care Research Institute (IDIAP), Barcelona Date of approval: 04/04/2007 (ref: P07/25) |
| Study design | Multicentric randomised controlled trial. |
| Countries of recruitment | Spain |
| Disease/condition/study domain | Subacute low back pain |
| Participants - inclusion criteria |
1. Men and women
2. Aged between 18 and 65 3. Those who present a current episode of non-specific subacute low back pain, the duration of which should last from 15 days to less than 12 weeks (after ruling out the red flag signs for potentially severe illnesses, listed in the exclusion criteria section) 4. Attended during the study recruiting period 5. Who agree to and sign the informed consent 6. Who understand Catalan or Spanish 7. Who remain at the same address for at least six months |
| Participants - exclusion criteria |
1. Unwillingness to participate in the multidisciplinary intervention trial
2. Pregnancy or breast-feeding mothers 3. Concomitant drug or other substances abuse 4. Anti-inflammatory intolerance or allergy 5. Patients who had treatment for physical problems in the preceding three months and those referred for intensive functional restoration programmes 6. Coexisting cognitive impairment or any other cause of inability to answer the various questionnaires 7. Severe psychiatric disorders: Psychosis, major depression, etc. 8. Presence of red flag signs for potentially severe illnesses |
| Anticipated start date | 01/01/2009 |
| Anticipated end date | 31/12/2010 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 348 patients per group (total 696) |
| Interventions |
Control group (Standard clinical practice):
Individual intervention based on the application of the "Clinical Practice Guidelines in the Pathology of the Lumbar Spine in Adults" recommendations, published by the Catalan Institute of Health (Institut Cátala de la Salut). Multidisciplinary intervention group: Individual intervention following the recommendations of the clinical practice guidelines plus educational group intervention plus educational DVD. Educational group intervention: Intervention will consist of 4 sessions over 1 month, 2 hours per session. The first 50 min of the session will be theoretical and the rest practical. There will be 2 sessions about physical measures to prevent back pain and 2 sessions on psychological aspects to control back pain. They will be given by a nurse trained by an expert psychologist and an expert physiotherapist. Educational DVD: Educational DVD will cover general aspects of back pain and physical and psychological aspects to prevent it in usual life. It will also give answers to the most frequently asked questions about back pain. |
| Primary outcome measure(s) |
The following will be measured at baseline, 3 and 12 months:
1. Pain intensity, assessed by the Spanish version of the Mc Gill Pain Questionnaire (Melzac, 1975) 2. Disability, assessed by the Roland Morris Questionnaire 3. Quality of Life, assessed by the 36-item Short Form health survey (SF-36) 4. Duration of the current episode of low back pain (pre-study and during the study) 5. Work sick leave (yes or no) 6. Duration in days of work sick leave 7. Percentage of change in pharmacological treatments |
| Secondary outcome measure(s) | Satisfaction with care measured at baseline, 3 and 12 months. |
| Sources of funding | La Marató de TV3 Foundation (Fundació La Marató de TV3) (Spain) |
| Trial website | |
| Publications | |
| Contact name | Dr Montse Balagué Corbella |
| Address |
l’Institut d’Investigació i Recerca en Atenció Primària (IDIAP)
Av. Gran Via de les Corts Catalanes, 587 Atic |
| City/town | Barcelona |
| Zip/Postcode | 08007 |
| Country | Spain |
| Sponsor | La Marató de TV3 Foundation (Fundació La Marató de TV3) (Spain) |
| Address | Ganduxer, 117 |
| City/town | Barcelona |
| Zip/Postcode | 08022 |
| Country | Spain |
| Tel | +34 93 444 48 30 |
| Fax | +34 93 444 48 32 |
| idiap@idiapjgol.org | |
| Sponsor website: | http://www.fundaciomaratotv3.cat |
| Date applied | 17/04/2008 |
| Last edited | 09/05/2008 |
| Date ISRCTN assigned | 09/05/2008 |
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