The cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in non-specific sub-acute low back pain in the working population in Catalonia

Not Applicable

Completed

• Conditions: Sub acute low back pain; Musculoskeletal Diseases; Low back pain

• Registration Number: ISRCTN58719694
• Lead Sponsor: TV3 Marathon Foundation (Fundació La Marató de TV3) (Spain)

Brief Summary

2011 protocol in https://pubmed.ncbi.nlm.nih.gov/21859489/ (added 17/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-04
• Study Completion: 2013-12-15
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 932

Inclusion Criteria

1. The current episode of LBP occurs suddenly after at least 6 months without LBP and lasts between 15 days and 12 weeks
2. Do not fulfil any of the exclusion criteria
3. Furthermore, patients must be between 18 and 65 years old
4. Can understand Catalan or Spanish
4. Available to participate for at least 12 months

Exclusion Criteria

1. They are unwilling to participate in the multidisciplinary intervention trial
2. LBP coexists with cognitive impairment, severe psychiatric disorders such as psychosis, or severe major depression
3. Any other cause of disability impedes answering the various questionnaires
4. They are pregnant or breast-feeding
5. They might have anti-inflammatory intolerance or allergy
6. Treatment has been received for physical problems in the preceding 3 months
7. They have been referred for intensive functional restoration programmes
8. Tthey have a confirmed diagnosis of fibromyalgia
9. Furthermore, the general practioner has to ensure that the patient has no red flag signs or symptoms that are frequently associated with specific LBP or potentially severe illnesses

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. The primary effectiveness measures of the study consist of Roland Morris Disability Questionnaire (RDQ) (scale 0-24; lower score indicates lower disability), Mc Gill Pain Questionnaire (including VAS 1-10; lower score indicates less pain), and Goldberg questionnaire on anxiety and depression<br> 2. Duration of days of pain, the reduction of days off work, the reduction of prescription, the duration of pharmacological treatments and recurrent episodes of LBP and the incidence of chronic LBP at 12 months will be measured<br> 3. The primary utility measure of the study is quality adjusted life years (QALYs), and will be calculated from the SF-12 scores (scale 0-100; lower score indicates poorer quality of life)<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Inadequate behaviour and work factors assessed by Fear Avoidance Beliefs Questionnaire (FAB) (scale 0-24; lower score indicates lower fear-avoidance belief), and the Goldberg questionnaire of anxiety and depression (each scale 0-9; lower scores indicates less anxiety or depression)<br> 2. All these questionnaires are validated in Spanish<br> 3. Patient?s assessment of global perceived effect on health will be measured by self-assessment with a Likert 7-point scale<br>