Chronic Low Back Pain: A Multidisciplinary Approach (CLBP-HUVH)

Vall d'Hebron University Hospital (HUVH)

Status: Completed

Conditions: Chronic Pain

Treatments: Other: Intervention 1; Other: Physiotherapy; Behavioral: Intervention 2

Study type: Interventional

Funder types: Other

Identifiers

NCT01993355

CLBP-PT_ATR_274-2012

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 3 patient groups

TAU

Active Comparator group

Description:

Control group. Treatment as usual (TAU): Physiotherapy program for CLBP.

Treatment:

Other: Physiotherapy

Intervention 1 Relaxation techniques-sophrology

Experimental group

Description:

Intervention group 1: TAU + relaxation techniques-sophrology program.

Treatment:

Other: Physiotherapy

Other: Intervention 1

Intervention 2 Cognitive-behavioral therapy

Experimental group

Description:

Intervention group 2: TAU + cognitive-behavioral therapy.

Treatment:

Behavioral: Intervention 2

Other: Physiotherapy