Chronic Low Back Pain: A Multidisciplinary Approach

Study Overview
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Brief Summary
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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.

Official Title
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A Multidisciplinary Approach to Treat and Rehabilitate Patients With Chronic Low Back Pain

Conditions
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Chronic Pain

Intervention / Treatment
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* Other: Physiotherapy
* Other: Intervention 1
* Behavioral: Intervention 2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAU<br>Control group. Treatment as usual (TAU): Physiotherapy program for CLBP. | Other: Physiotherapy<br>* Physical therapy exercise program for CLBP patients. Its goal is to reduce pain and improve patients' health-related quality of life, functional capacity and well-being.<br>* Other names: Treatment as usual (TAU);|
| Experimental: Intervention 1 Relaxation techniques-sophrology<br>Intervention group 1: TAU + relaxation techniques-sophrology program. | Other: Physiotherapy<br>* Physical therapy exercise program for CLBP patients. Its goal is to reduce pain and improve patients' health-related quality of life, functional capacity and well-being.<br>* Other names: Treatment as usual (TAU);Other: Intervention 1<br>* Relaxation techniques-sophrology consists of a set of physical and relaxation exercises that include breathing methods, visualization, modification of states of consciousness, etc. with the goal to enhance balance between body and mind to improve health-related quality of life, reduce pain and foster patients' well-being.<br>* Other names: Relaxation techniques-sophrology;|
| Experimental: Intervention 2 Cognitive-behavioral therapy<br>Intervention group 2: TAU + cognitive-behavioral therapy. | Other: Physiotherapy<br>* Physical therapy exercise program for CLBP patients. Its goal is to reduce pain and improve patients' health-related quality of life, functional capacity and well-being.<br>* Other names: Treatment as usual (TAU);Behavioral: Intervention 2<br>* Cognitive-behavioral therapy (in combination with motivational interviewing principles) is aimed to facilitate psychological adjustment and self-management of CLBP with the ultimate goal of increasing patients' health-related quality of life and well-being.<br>* Other names: CBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The SF-12v2 Health Status Questionnaire (change is being assessed) | The SF-12 measures health-related quality of life including items from various domains both physical and psychological. | Baseline, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS for Self-perceived Pain | Visual Analogue Scale to rate self-perceived pain. Recall period: last 4 weeks. | Baseline, 6 and 12 months | 
| Oswestry-15 Disability Index | The Oswestry Disability Index (aka: Oswestry Low Back Pain Disability Questionnaire) is a time-tested outcome assessment tool that is used to measure a patient's impairment and quality of life (i.e., how badly the pain has affected their life). | Baseline, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-specific chronic low back pain,, health-related quality of life,, physioterapy,, sophrology,, cognitive-behavioral therapy,, motivational interviewing