Subacute low back pain Musculoskeletal Diseases Low back pain
Conditions
Interventions
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 o
Sponsors
La Marató de TV3 Foundation (Fundació La Marató de TV3) (Spain)
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Spain
Outcome results
None listed