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Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain

This study has been completed.
Sponsor:
Collaborators:
Central Institute of Mental Health, Mannheim
University of Mannheim
Academic City Hospital, Germany
BG Trauma Center Ludwigshafen
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00176163
First received: September 13, 2005
Last updated: February 1, 2010
Last verified: September 2005

September 13, 2005
February 1, 2010
August 2005
Not Provided
Impairment by pain
Same as current
Complete list of historical versions of study NCT00176163 on ClinicalTrials.gov Archive Site
  • Pain intensity
  • physical function and emotional state assessed by questionnaires
  • number of serious adverse events
  • subjective rating of improvement by therapy
  • subjective rating of therapy effectiveness
  • therapy satisfaction rated by patient
Same as current
Not Provided
Not Provided
 
Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain
Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain

It is known, that a so called "pain memory" usually evolves in chronic pain syndromes which both aggravates the disorder and modifies the patients pain perception. Thus, the principal object of pain therapy is to "delete" this dysfunctional pain memory. The combination of medication, physiotherapy and psychological therapy seems to be the most effective treatment. This study investigates the effect of a concomitant Dronabinol medication (Cannabinoid) on the effectiveness of behavioral therapy. It is hypothesized that the combination of behavioral therapy and Dronabinol will be most effective in deleting the pain memory.

This study investigates the combination of operant behavioral treatment and Cannabinoid medication in patients with fibromyalgia and patients with back pain. It is well known that cannabinoids (THC) accelerate learning processes. It is assumed that the combination of both treatments may exert an synergetic effect. A low dose of THC is used, which ist not expected to have direct analgetic effects. The study also investigates genetic determinants of both disorders and the response to treatment, respectively.

The patients will be randomly assigned to one of four groups: Behavioral therapy and Dronabinol, behavioral therapy and placebo, behavioral therapy only, standard medical therapy. Patients will attend 12 weekly group-sessions (6-8 patients) of behavioral therapy. Behavioral therapy sessions will include training in reducing pain behaviour and establishing active and "healthy" behaviour instead. There will be weekly medical safety visits, in which the patients receive medication and undergo a physical examination (blood and urine samples).

Patients will be evaluated before and after behavioral therapy and will be followed for an additional 6- and 12-months phase. The outcome variables will be recorded by the use of interviews and questionnaires.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Fibromyalgia
  • Back Pain
Behavioral: Operant behavioral treatment; Drug: THC
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
May 2009
Not Provided

Inclusion Criteria:

  • Diagnosis of Fibromyalgia meeting ACR-criteria
  • Diagnosis of chronic back pain
  • Pain duration exceeding 3 months
  • Age between 18 and 70 years
  • The patient has been informed about the study, understood the information and signed the informed consent form

Exclusion Criteria:

  • Tumors, fractures and heavy osteoporosis
  • Secondary back pain at arthrosis or degenerative scoliosis
  • Radicular back pain
  • Other pain syndrome is main problem
  • Opiate medication > 60mg morphine per diem
  • Addiction (drugs, alcohol, medicaments)
  • Cardiac insufficiency > NYHA II
  • Exercise induced dyspnea, Angina pectoris A detailed version of exclusion criteria: see study protocol
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00176163
kfg107
Not Provided
Not Provided
Heidelberg University
  • Central Institute of Mental Health, Mannheim
  • University of Mannheim
  • Academic City Hospital, Germany
  • BG Trauma Center Ludwigshafen
Principal Investigator: Justus Benrath, MD, PhD Heidelberg University
Heidelberg University
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP