Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain
Information source: University of Heidelberg
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fibromyalgia; Back Pain
Intervention: Operant behavioral treatment; Drug: THC (Behavioral)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Heidelberg Official(s) and/or principal investigator(s):
Christoph Konrad, MD, PhD, Study Director, Affiliation: University of Heidelberg
Overall contact:
Christoph Konrad, MD, PhD, Phone: 0049 621 383 2608, Email: christoph.konrad@anaes.ma.uni-heidelberg.de
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.
Clinical Details
Official title: Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
Primary outcome: Impairment by pain
Secondary outcome: Pain intensityphysical 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
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) 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Christoph Konrad, MD, PhD, Phone: 0049 621 383 2608, Email: christoph.konrad@anaes.ma.uni-heidelberg.de
University Hospital, Mannheim, BaWü 68167, Germany; Recruiting
Christoph Konrad, MD, PhD, Phone: 0049 621 383 2608, Email: christoph.konrad@anaes.ma.uni-heidelberg.de
Christoph Konrad, MD, PhD, Principal Investigator
Additional Information
Starting date: August 2005
Ending date: August 2008
Last updated: September 13, 2005
|
