NCT00360802

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

May 28, 2009

Status Verified

May 1, 2009

Enrollment Period

2.8 years

First QC Date

August 4, 2006

Last Update Submit

May 27, 2009

Conditions

Chronic Low Back Pain

Keywords

chronic low back paincognitive-behavioral therapyMindful Based Stress Reductionpain clinicsanxietyquality of lifechronic pain

Outcome Measures

Primary Outcomes (1)

  • Degree of improvement in: anxiety, quality of life

    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

    immediately after therapy, at 3 months, and at 12 months

Study Arms (2)

CBT

ACTIVE COMPARATOR

Cognitive Behavioral Treatment

Behavioral: Cognitive Behavioral Treatment

MBSR

ACTIVE COMPARATOR

Mindfulness Based Stress Reduction

Behavioral: Mindfulness Based Stress Reduction

Interventions

Cognitive Behavioral TreatmentBEHAVIORAL

Behavioral treatment to reduce pain in chronic back pain patients

CBT
Mindfulness Based Stress ReductionBEHAVIORAL

Behavioral treatment to reduce pain in chronic back pain patients

MBSR

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bellaterra, Barcelona, Catalonia, 08193, Spain

Location

Related Publications (4)

  • Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. doi: 10.1056/NEJM200102013440508. No abstract available.

    PMID: 11172169BACKGROUND

  • van Tulder MW, Ostelo R, Vlaeyen JW, Linton SJ, Morley SJ, Assendelft WJ. Behavioral treatment for chronic low back pain: a systematic review within the framework of the Cochrane Back Review Group. Spine (Phila Pa 1976). 2000 Oct 15;25(20):2688-99. doi: 10.1097/00007632-200010150-00024.

    PMID: 11034658BACKGROUND

  • Basler HD, Jakle C, Kroner-Herwig B. Incorporation of cognitive-behavioral treatment into the medical care of chronic low back patients: a controlled randomized study in German pain treatment centers. Patient Educ Couns. 1997 Jun;31(2):113-24. doi: 10.1016/s0738-3991(97)00996-8.

    PMID: 9216352BACKGROUND

  • Moix J, Kovacs FM, Martin A, Plana MN, Royuela A; Spanish Back Pain Research Network. Catastrophizing, state anxiety, anger, and depressive symptoms do not correlate with disability when variations of trait anxiety are taken into account. a study of chronic low back pain patients treated in Spanish pain units [NCT00360802]. Pain Med. 2011 Jul;12(7):1008-17. doi: 10.1111/j.1526-4637.2011.01155.x. Epub 2011 Jun 13.

    PMID: 21668743DERIVED

Related Links

MeSH Terms

Conditions

Anxiety DisordersChronic Pain

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Mental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Francisco M. Kovacs, MD, PhD

    Kovacs Foundation, Palma de Mallorca, 07012, Spain

    STUDY CHAIR

  • Jenny Moix, PhD

    Departamento de Psicología Básica, Universidad Autónoma de Barcelona, Bellaterra, Barcelona 08193, Spain

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 4, 2006

First Posted

August 7, 2006

Study Start

May 1, 2006

Primary Completion

March 1, 2009

Study Completion

May 1, 2009

Last Updated

May 28, 2009

Record last verified: 2009-05

Locations

ES(1)