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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00360802
Enrollment
330
Registered
2006-08-07
Start date
2006-05-31
Completion date
2009-05-31
Last updated
2009-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain

Keywords

chronic low back pain, cognitive-behavioral therapy, Mindful Based Stress Reduction, pain clinics, anxiety, quality of life, chronic pain

Brief summary

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.

Interventions

Behavioral treatment to reduce pain in chronic back pain patients

BEHAVIORALMindfulness Based Stress Reduction

Behavioral treatment to reduce pain in chronic back pain patients

Sponsors

Spanish Back Pain Research Network (REIDE)
CollaboratorOTHER
Fondo de Investigacion Sanitaria
CollaboratorOTHER
Universitat Autonoma de Barcelona
CollaboratorOTHER
Kovacs Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Degree of improvement in: anxiety, quality of lifeimmediately after therapy, at 3 months, and at 12 months

Secondary

MeasureTime frame
Degree of improvement in: pain, disability, catastrophizing, depression, anger, analgesic medication, satisfaction with treatment receivedimmediately after therapy, at 3 months, and at 12 months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026