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
| ISRCTN | ISRCTN58719694 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58719694 |
| Secondary identifying numbers | 1 |
- Submission date
- 28/06/2011
- Registration date
- 04/08/2011
- Last edited
- 17/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Lower back pain is one of the main reasons for consulting a GP. It has an important impact on patients’ quality of life and their ability to perform daily tasks. When lower back pain is diagnosed early intervention is necessary to avoid it becoming chronic (long-term). Psychological and social factors should be considered because they could affect the level of pain and increase the risk of chronic lower back pain. Given that the guidelines consider a range of interventions to be effective, it is important to assess the effectiveness of treatments compared with the current intervention. The aim of this study is to assess the cost-effectiveness and cost-utility of a educational group intervention in comparison with the usual care for lower back pain.
Who can participate?
Patients aged 18 to 65 with lower back pain
What does the study involve?
Participants are randomly allocated to one of two groups. Participants allocated to the control group receive usual clinical care and individual intervention. In addition to the same individual intervention as the control group, participants allocated to the intervention group also receive an educational booklet and an educational group intervention carried out by a GP, a nurse, a psychologist and a physiotherapist. The intervention consists of 2 sessions of 4 hours duration each and 1 session of 2 hours duration, including up to 12 participants. The effectiveness and costs of both interventions are measured.
What are the possible benefits and risks of participating?
Not provided at time of registration
When does the study take place?
July 2011 to December 2012
Where is the study run from?
38 Catalan primary health care centres (Spain)
Who is funding the study?
Fundació La Marató de TV3 (Spain)
Who is the main contact?
Dr Concepció Violan Fors
Contact information
Scientific
Gran Via Corts Catalanes
587 àtic
Barcelona
080007
Spain
Study information
| Study design | Cluster randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Study protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population in Catalonia: cluster randomised trial |
| Study objectives | The multidisciplinary biopsychosocial educational group intervention (MBEGI) is cost-effectiveness and cost-utility in comparison with the usual care of non-specific sub-acute low back pain (LBP) in the working population recruited in Barcelona and its surrounding Primary Health Care Centres (PHCC) since May 2009. |
| Ethics approval(s) | IDIAP Jordi Gol Ethics Committee, 27/04/2011 |
| Health condition(s) or problem(s) studied | Sub acute low back pain |
| Intervention | Patients allocated to the control group will receive usual clinical care, and individual intervention based on the application of the Clinical Practice Guidelines in the Pathology of the Lumbar Spine in Adults. These recommendations are published by the Catalan Institute of Health (Institut Català de la Salut). In addition to the same individual intervention as the control group, patients allocated to the intervention group will receive an educational booklet The Back Manual (a transculturally adapted Spanish version of the Back Book) and a biopsychosocial multidisciplinary group intervention. The group intervention will be carried out by a GP, a nurse, a psychologist and a physiotherapist. The programme consists of 2 sessions of 4 hours duration each and 1 session of 2 hours duration. Each group includes up to 12 participants. To guarantee the standardisation of the group sessions, only one qualified psychologist and one physiotherapist, both of them with extensive expertise in development of training groups, will apply the intervention in all PHCCs. |
| Intervention type | Other |
| Primary outcome measure | 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 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 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) |
| Secondary outcome measures | 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) 2. All these questionnaires are validated in Spanish 3. Patients assessment of global perceived effect on health will be measured by self-assessment with a Likert 7-point scale |
| Overall study start date | 15/07/2011 |
| Completion date | 15/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 932 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/07/2011 |
| Date of final enrolment | 15/12/2013 |
Locations
Countries of recruitment
- Spain
Study participating centre
080007
Spain
Sponsor information
Charity
Carrer de la TV3
s/n 08970 Sant Joan Despí
Barcelona
08970
Spain
| Website | http://www.tv3.cat/marato |
|---|---|
"ROR" |
https://ror.org/00t5xc355 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 22/08/2011 | 17/12/2020 | Yes | No |
Editorial Notes
17/12/2020: Publication reference added.
04/08/2016: Plain English summary added.
