Status:
COMPLETED
Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain
Lead Sponsor:
Heidelberg University
Collaborating Sponsors:
Central Institute of Mental Health, Mannheim
University of Mannheim
Conditions:
Fibromyalgia
Back Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 t...
Detailed Description
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) a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00176163
Start Date
August 1 2005
End Date
May 1 2009
Last Update
February 2 2010
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