Effectiveness of Cognitive Behavioral Treatment and Mindfulness Based Stress Reduction (MBSR) for Chronic Low Back Pain

May 27, 2009 updated by: Kovacs Foundation

The Effectiveness of Cognitive Behavioral Treatment and Mindfulness Based Stress Reduction for Chronic Low Back Pain Treated in Pain Clinics

The primary purpose of this study is to determine the effectiveness of two psychological techniques in chronic low back pain patients treated in hospital pain clinics. The techniques are: cognitive behavioral treatment and mindfulness based stress reduction (MBSR). This is a multiple site project in which patients come from 16 different pain clinics throughout Spain. The control group is formed by patients under usual medical treatment at pain clinics. The two intervention groups also receive usual medical treatment at pain clinics plus one psychological therapy treatment. The sample size is 330 subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

330

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Cataluña
      • Bellaterra, Barcelona, Cataluña, Spain, 08193
        • Universidad Autónoma de Barcelona, Dept. Psicología Básica, Evolutiva y de la Educación

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic low back pain and failed back surgery patients
  • With or without referred or radiated pain
  • Who are between 18 and 70 years of age (inclusive)

Exclusion Criteria:

  • Patients with red flags for systemic disease or criteria for surgery
  • With intolerable intensity of pain despite 6 weeks or more of non-surgical treatment
  • With pain that appears only on walking and disappears with sitting, persists after 6 months of conservative treatment, and is a possible spinal stenosis
  • Under psychological or psychiatric treatment
  • Unable to fill out the questionnaires
  • Have received cognitive behavioral treatment in the past
  • Have ongoing work litigation or are in the process of obtaining permanent disability.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CBT
Cognitive Behavioral Treatment
Behavioral: Cognitive Behavioral Treatment
Behavioral treatment to reduce pain in chronic back pain patients
Active Comparator: MBSR
Mindfulness Based Stress Reduction
Behavioral: Mindfulness Based Stress Reduction
Behavioral treatment to reduce pain in chronic back pain patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Degree of improvement in: anxiety, quality of life
Time Frame: immediately after therapy, at 3 months, and at 12 months
immediately after therapy, at 3 months, and at 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Degree of improvement in: pain, disability, catastrophizing, depression, anger, analgesic medication, satisfaction with treatment received
Time Frame: immediately after therapy, at 3 months, and at 12 months
immediately after therapy, at 3 months, and at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kovacs Foundation

Collaborators

Fondo de Investigacion Sanitaria
Universitat Autonoma de Barcelona
Spanish Back Pain Research Network (REIDE)

Investigators

  • Study Chair: Francisco M. Kovacs, MD, PhD, Kovacs Foundation, Palma de Mallorca, 07012, Spain
  • Principal Investigator: Jenny Moix, PhD, Departamento de Psicología Básica, Universidad Autónoma de Barcelona, Bellaterra, Barcelona 08193, Spain
  • Study Director: María José Martín, Hospital Mutua de Terrasa, Terrasa 08221, Spain
  • Study Director: María Angeles Pastor, Hospital General y Universitario de Alicante, Alicante 03010, Spain
  • Study Director: María Isabel Casado, PhD, Hospital 12 de Octubre, Madrid 28041, Soain
  • Study Director: Carlos Peña, PhD, Hospital Universitario Marqués de Valdecilla, Santander 39008, Spain
  • Study Director: Andrés Martín, BS, Hospital de Son Llatzer, Palma de Mallorca 07198, Spain
  • Study Director: Gema Rodríguez, Hospital Severo Ochoa, Leganés, Madrid 28911, Spain
  • Study Director: Francisco Javier Cano, PhD, Hospital Universitario Virgen del Rocío, Sevilla 41013, Spain
  • Study Director: Milena Gobbo, BS, Fundación Hospital Alcorcón, Madrid 28922, Spain
  • Study Director: Almudena Mateos, BS, Fundación Hospital Alcorcón, Madrid 28922, Spain
  • Study Director: Carla Casals, BS, Hospital de Figueres, Figueres 17600, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

August 4, 2006

First Submitted That Met QC Criteria

August 4, 2006

First Posted (Estimate)

August 7, 2006

Study Record Updates

Last Update Posted (Estimate)

May 28, 2009

Last Update Submitted That Met QC Criteria

May 27, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FK-FIS-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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