Skip to main content
OpenTrials
Completed

NCT Number: NCT00360802

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Low Back Pain Anxiety Disorders Chronic Pain Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universidad Autónoma de Barcelona, Dept. Psicología Básica, Evolutiva y de la Educación

Bellaterra, Barcelona, Catalonia, 08193, Spain

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Cognitive Behavioral Treatment

Behavioral

Behavioral treatment to reduce pain in chronic back pain patients

Mindfulness Based Stress Reduction

Behavioral

Behavioral treatment to reduce pain in chronic back pain patients

Primary outcomes

  1. Degree of improvement in: anxiety, quality of life

    Time frame: immediately after therapy, at 3 months, and at 12 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Kovacs Foundation

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Aug 7, 2006
Registry last updated
May 28, 2009

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.