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NCT Number: NCT01993355

Chronic Low Back Pain: A Multidisciplinary Approach

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Vall d'Hebron Institut de Recerca Vall d'Hebron

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiotherapy

Other

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.

Other names: Treatment as usual (TAU)

Intervention 1

Other

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.

Other names: Relaxation techniques-sophrology

Intervention 2

Behavioral

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.

Other names: CBT

Primary outcomes

  1. 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

  1. VAS for Self-perceived Pain

    Time frame: Baseline, 6 and 12 months

    Visual Analogue Scale to rate self-perceived pain. Recall period: last 4 weeks.

  2. Oswestry-15 Disability Index

    Time frame: 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).

Other outcomes

  1. LISAT-8

    Time frame: Baseline, 6 and 12 months

    The LISAT is a domain-specific measure of life satisfaction, which corresponds to Box E (subjective evaluations and reactions; life satisfaction) of Dijker's Model.

  2. STAI

    Time frame: Baseline, 6 and 12 months

    The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to screen anxiety and to distinguish it from depressive syndromes.

  3. BDI-13

    Time frame: Baseline, 6 and 12 months

    The Beck Depression Inventory (BDI) is a 13-item (short-form), self-report rating inventory that measures characteristic attitudes and symptoms of depression.

  4. PSQI

    Time frame: Baseline, 6 and 12 months

    The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality during the previous month.

  5. CAD

    Time frame: Baseline and 12 months

    The CAD (Cuestionario para el Afrontamiento al Dolor) is a coping questionnaire to chronic pain developed in a Spanish sample.

  6. TAS-20

    Time frame: Baseline and 12 months

    The Toronto Alexithymia Scale (TAS) 20-item is one of the most commonly used measures of alexithymia (people who have trouble identifying and describing emotions and who tend to minimise emotional experience and focus attention externally).

  7. PSS-14

    Time frame: Baseline and 12 months

    The Perceived Stress Scale (PSS) is a 14-item questionnaire that measures the degree to which life events are considered stressful.

  8. DUKE-11

    Time frame: Baseline and 12 months

    The DUKE 11-item social support questionnaire measures an individual's perception of the amount and type of personal social support. The original instrument included 14 items, grouped into 4 subscales: Quantity of Support, Confidant Support, Affective Support, and Instrumental Support.

  9. VAS for patient satisfaction with treatment received

    Time frame: Baseline, 6 and 12 months

    Visual Analogue Scale to rate patients' satisfaction with treatment, attention received and outcomes.

  10. Medical and demographics

    Time frame: Baseline

    Medical (medical and psychopathological history, physical exploration of LBP and possible substance abuse or other toxic habits such as alcohol or tobacco) and demographics (age, gender, immediate family network, education, job and SES) of patients are collected according to standard procedures.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

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

Acronym: CLBP-HUVH

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Nov 25, 2013
Registry last updated
Jun 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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