Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
071610
Study information
Scientific title
Effectiveness of a multidisciplinary intervention in the evolution of non-speficic subacute low back pain in the working population
Acronym
MILUPA
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
Added 01/02/10:
The study will be a randomised controlled clinical trial with Primary Health Care Centers randomly allocated to a multidisciplinary intervention or to usual clinical care
Please note that as of 01/02/10 this record has been extensively updated. All updates can be found in the relevant field with the above update date. Please also note that the number of participants has increased from 696 to 932 in total between both arms and the anticipated end date has been extended from 31/12/2010 to 31/12/2011.
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
Multicentrre cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request the educational leaflet,Handbook of your back (validated), or an educational DVD
Condition
Subacute low back pain
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 measures
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
Overall trial start date
01/01/2009
Overall trial end date
31/12/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
466 patients per group (total 932) (added 01/02/10)
Participant 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
Recruitment start date
01/01/2009
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Spain
Trial participating centre
lInstitut dInvestigació i Recerca en Atenció Primària (IDIAP)
Barcelona
08007
Spain
Sponsor information
Organisation
La Marató de TV3 Foundation (Fundació La Marató de TV3) (Spain)
Sponsor details
Ganduxer
117
Barcelona
08022
Spain
+34 93 444 48 30
idiap@idiapjgol.org
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
La Marató de TV3 Foundation (Fundació La Marató de TV3) (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20067619
Publication citations
-
Protocol
Rodriguez-Blanco T, Fernández-San-Martin I, Balagué-Corbella M, Berenguera A, Moix J, Montiel-Morillo E, Núñez-Juárez E, González-Moneo MJ, Pie-Oncins M, Martín-Peñacoba R, Roura-Olivan M, Núñez-Juárez M, Pujol-Ribera E, Study protocol of effectiveness of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial., BMC Health Serv Res, 2010, 10, 12, doi: 10.1186/1472-6963-10-12.