Chronic Low Back Pain: A Multidisciplinary Approach

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Other: Physiotherapy; Behavioral: Intervention 2; Other: Intervention 1

• Registration Number: NCT01993355
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-11-11
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-25
• Primary Completion: 2014-11
• Study Completion: 2015-01
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-15
• Last Update Posted: 2015-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention 2 Cognitive-behavioral therapy	Physiotherapy	Intervention group 2: TAU + cognitive-behavioral therapy.
Intervention 1 Relaxation techniques-sophrology	Physiotherapy	Intervention group 1: TAU + relaxation techniques-sophrology program.
Intervention 2 Cognitive-behavioral therapy	Intervention 2	Intervention group 2: TAU + cognitive-behavioral therapy.
TAU	Physiotherapy	Control group. Treatment as usual (TAU): Physiotherapy program for CLBP.
Intervention 1 Relaxation techniques-sophrology	Intervention 1	Intervention group 1: TAU + relaxation techniques-sophrology program.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Oswestry-15 Disability Index	Baseline, 6 and 12 months	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).
VAS for Self-perceived Pain	Baseline, 6 and 12 months	Visual Analogue Scale to rate self-perceived pain. Recall period: last 4 weeks.

Trial Locations

Locations (1)

Hospital Universitari Vall d'Hebron Institut de Recerca Vall d'Hebron; 🇪🇸 Barcelona, Spain