A Multidisciplinary Approach to Treat and Rehabilitate Patients With Chronic Low Back Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- The SF-12v2 Health Status Questionnaire (change is being assessed)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
Introduction: Non-specific chronic low back pain (CLBP) is one of the most frequent causes for patient disability and a general recurrent cause for medical consultation with high costs to public health. From rehabilitative medicine, physiotherapy is commonly offered. Although this treatment is aimed to reduce disability, pain severity and pain-related anxiety-depressive symptoms, many patients report partial improvement and recurrent intensive and disabling pain episodes. Therefore, a new approach in the treatment and rehabilitation of this pathology that takes into account psychosocial aspects that might be modulating pain is necessary.
Material and methods: This project aims to assess the efficacy of two complementary interventions to standard physical therapy, such as relaxation techniques and cognitive-behavioral intervention, to improve health-related quality of life (HRQoL) among patients with CLBP. It is hypothesized that groups receiving these complementary interventions will significantly improve their adherence to physiotherapy and the control of their pain and, ultimately, these aspects will facilitate a decreasing of pain intensity and better HRQoL.
For these purposes, a pre-post longitudinal design will be carried out, with follow-up assessments at 6 and 12 months in a sample of 66 participants. This sample will be divided into: control group (physiotherapy), intervention group 1 (physiotherapy and relaxation techniques-sophrology) and intervention group 2 (physiotherapy and cognitive-behavioral intervention).
Expected impact: Study results are not available yet. However, if working hypotheses are confirmed, a multidisciplinary model of care for CLBP will be empirically justified. This approach is expected to benefit HRQoL among these patients implying a significant short-mid term reduction of public health costs.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Non-specific chronic (\> 6 months of evolution) low back pain diagnosis
- •Ability to read and speak in Spanish
Exclusion Criteria
- •Addictive behaviors (DAST-10 \> 3, alcoholism, drug addiction or other drug abuse)
- •Psychiatric contraindications (BDI \> 15 or other severe psychiatric disorder not stabilized)
- •Neurological impairment
- •No mental competence (MEC \< 23)
- •Fibromyalgia and/or chronic fatigue
Outcomes
Primary Outcomes
The SF-12v2 Health Status Questionnaire (change is being assessed)
Time Frame: Baseline, 6 and 12 months
The SF-12 measures health-related quality of life including items from various domains both physical and psychological.
Secondary Outcomes
- Oswestry-15 Disability Index(Baseline, 6 and 12 months)
- VAS for Self-perceived Pain(Baseline, 6 and 12 months)