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

K

Kovacs Foundation

Status and phase

Completed
Phase 2

Conditions

Chronic Low Back Pain

Treatments

Behavioral: Cognitive Behavioral Treatment
Behavioral: Mindfulness Based Stress Reduction

Study type

Interventional

Funder types

Other

Identifiers

NCT00360802
FK-FIS-22

Details and patient eligibility

About

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.

Enrollment

330 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

330 participants in 2 patient groups

CBT
Active Comparator group
Description:
Cognitive Behavioral Treatment
Treatment:
Behavioral: Cognitive Behavioral Treatment
MBSR
Active Comparator group
Description:
Mindfulness Based Stress Reduction
Treatment:
Behavioral: Mindfulness Based Stress Reduction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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