Effectiveness of a multidisciplinary intervention in subacute low back pain in the working population

• Register: ISRCTN
• Last refreshed on: 12 February 2013
• Main ID: ISRCTN21392091
• Date of registration: 09/05/2008
• Primary sponsor: La Marató de TV3 Foundation (Fundació La Marató de TV3) (Spain)
• Public title: Effectiveness of a multidisciplinary intervention in subacute low back pain in the working population MILUPA
• Scientific title: Effectiveness of a multidisciplinary intervention in the evolution of non-speficic subacute low back pain in the working population
• Date of first enrolment: Jan 1 2009
• Target sample size: 466 patients per group (total 932) (added 01/02/10)
• Recruitment status: Completed/Not recruiting
• URL: http://isrctn.org/ISRCTN21392091
• Study type: Interventional
• Study design: Multicentrre cluster randomised controlled trial

Countries of recruitment

Spain

Contacts

• Name: Montse Balagué Corbella

Key inclusion & exclusion criteria

Inclusion criteria: Current information as of 01/02/10:
1. Men and women aged between 18 and 65, who present a current episode of non-specific subacute low back pain, occurs suddenly after a period of a minimum of 6months without LBP and lasts between 15 days and 12 weeks (after ruling out the red flag signs for potentially severe illnesses, listed in the exclusion criteria section)
2. Attended during the study recruiting period
3. Who agree to and sign the informed consent
4. Who understand Catalan or Spanish
5. Who can be accessible for at least twelve months.

Initial information at time of registration:
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
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

Added 01/02/10:
9. Patients referred for intensive functional restoration programmes
10. Confirmed diagnosis of fibromialgia

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Subacute low back pain

Intervention(s)

Current information as of 01/02/10:
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 ?Institut Cátala de la Salut. Multidisciplinary Intervention Group: Individual intervention following the recommendations of clinical practice guidelines in addition to a biopsychosocial multidisciplinary intervention consisting of group educational sessions lasting a total of 10 hours and the Educational digital video disc (DVD).

Initial information at time of registration:
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(s)

Current information as of 01/02/10:
1. Disability (Roland Morris Questionnaire)
2. Pain intensity (Questionnaire Spanish version
3. Mc Gill Pain Questionnaire, Melzac, 1975)
4. Quality of Life Questionnaire (SF 12)
5. Duration of the current episode of LBP (pre-study and study duration)
6. Work sick leave (yes or not)
7. Duration in days of work sickleave
8. Percentage of change in pharmacological treatments.
9. Fear Avoidance Beliefs Questionnaire (FAB)
10. Goldberg Scale (Anxiety and Depression) Questionnaire
Outcomes will be measured at baseline, 3 moths, 6 and 12 months

Initial information at time of registration:
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
Outcomes will be measured at baseline, 3 and 12 months

Secondary Outcome(s)

Current information as of 01/02/10:
1. Satisfaction with care
2. Patients assesment of global perceived effect
Outcomes will be measured at baseline, 3, 6 and 12 months

Initial information at time of registration:
Satisfaction with care measured at baseline, 3 and 12 months

Secondary ID(s)

071610

Source(s) of Monetary Support

La Marató de TV3 Foundation (Fundació La Marató de TV3) (Spain)

Secondary Sponsor(s)

N/A