Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain
1 other identifier
interventional
240
0 countries
N/A
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2005
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFebruary 2, 2010
September 1, 2005
September 13, 2005
February 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Impairment by pain
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Heidelberg Universitylead
- Central Institute of Mental Health, Mannheimcollaborator
- University of Mannheimcollaborator
- Academic City Hospital, Germanycollaborator
- BG Trauma Center Ludwigshafencollaborator
Related Publications (1)
Finnern MM, Kleinbohl D, Flor H, Benrath J, Holzl R. Deconstructing chronicity of musculoskeletal pain: intensity-duration relations, minimal dimensions and clusters of chronicity. Scand J Pain. 2018 Jul 26;18(3):363-377. doi: 10.1515/sjpain-2018-0021.
PMID: 29870396DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Justus Benrath, MD, PhD
Heidelberg University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 15, 2005
Study Start
August 1, 2005
Study Completion
May 1, 2009
Last Updated
February 2, 2010
Record last verified: 2005-09