Clinical trial NCT00360802: Effectiveness of Cognitive Behavioral Treatment and Mindfulness Based Stress Reduction (MBSR) for Chronic Low Back Pain
Official title: The Effectiveness of Cognitive Behavioral Treatment and Mindfulness Based Stress Reduction for Chronic Low Back Pain Treated in Pain Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Kovacs Foundation
Sponsor class: OTHER
Collaborators: name: Spanish Back Pain Research Network (REIDE)
name: Fondo de Investigacion Sanitaria
name: Universitat Autonoma de Barcelona
First posted: 2006-08-07
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Degree of improvement in: anxiety, quality of life
timeFrame: immediately after therapy, at 3 months, and at 12 months
Secondary outcomes:
measure: Degree of improvement in: pain, disability, catastrophizing, depression, anger, analgesic medication, satisfaction with treatment received
timeFrame: immediately after therapy, at 3 months, and at 12 months
Other outcomes:
Locations:
city: Bellaterra, Barcelona
country: Spain
facility: Universidad Autónoma de Barcelona, Dept. Psicología Básica, Evolutiva y de la Educación
state: Cataluña
Study officials:
affiliation: Kovacs Foundation, Palma de Mallorca, 07012, Spain
name: Francisco M. Kovacs, MD, PhD
role: STUDY_CHAIR
affiliation: Departamento de Psicología Básica, Universidad Autónoma de Barcelona, Bellaterra, Barcelona 08193, Spain
name: Jenny Moix, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Mutua de Terrasa, Terrasa 08221, Spain
name: María José Martín
role: STUDY_DIRECTOR
affiliation: Hospital General y Universitario de Alicante, Alicante 03010, Spain
name: María Angeles Pastor
role: STUDY_DIRECTOR
affiliation: Hospital 12 de Octubre, Madrid 28041, Soain
name: María Isabel Casado, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario Marqués de Valdecilla, Santander 39008, Spain
name: Carlos Peña, PhD
role: STUDY_DIRECTOR
affiliation: Hospital de Son Llatzer, Palma de Mallorca 07198, Spain
name: Andrés Martín, BS
role: STUDY_DIRECTOR
affiliation: Hospital Severo Ochoa, Leganés, Madrid 28911, Spain
name: Gema Rodríguez
role: STUDY_DIRECTOR
affiliation: Hospital Universitario Virgen del Rocío, Sevilla 41013, Spain
name: Francisco Javier Cano, PhD
role: STUDY_DIRECTOR
affiliation: Fundación Hospital Alcorcón, Madrid 28922, Spain
name: Milena Gobbo, BS
role: STUDY_DIRECTOR
affiliation: Fundación Hospital Alcorcón, Madrid 28922, Spain
name: Almudena Mateos, BS
role: STUDY_DIRECTOR
affiliation: Hospital de Figueres, Figueres 17600, Spain
name: Carla Casals, BS
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.