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

• ClinicalTrials.gov Identifier: NCT00176163
• Recruitment Status: Completed
• First Posted: September 15, 2005
• Last Update Posted: February 2, 2010
• Sponsor: Heidelberg University
• Collaborators: Central Institute of Mental Health, Mannheim; University of Mannheim; Academic City Hospital, Germany; BG Trauma Center Ludwigshafen
• Information provided by: Heidelberg University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia; Back Pain	Behavioral: Operant behavioral treatment; Drug: THC	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain
• Study Start Date: August 2005
• Study Completion Date: May 2009

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Impairment by pain

Secondary Outcome Measures :

1. Pain intensity
2. physical function and emotional state assessed by questionnaires
3. number of serious adverse events
4. subjective rating of improvement by therapy
5. subjective rating of therapy effectiveness
6. therapy satisfaction rated by patient

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Sponsors and Collaborators

Heidelberg University

Central Institute of Mental Health, Mannheim

University of Mannheim

Academic City Hospital, Germany

BG Trauma Center Ludwigshafen

Investigators

• Principal Investigator: Justus Benrath, MD, PhD; Heidelberg University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Finnern MM, Kleinböhl D, Flor H, Benrath J, Hölzl 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.

• ClinicalTrials.gov Identifier: NCT00176163
• Other Study ID Numbers: kfg107
• First Posted: September 15, 2005
• Last Update Posted: February 2, 2010
• Last Verified: September 2005

Keywords provided by Heidelberg University:

Fibromyalgia; Back pain; Behavior Therapy; Operant learning; Tetrahydrocannabinol

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Back Pain; Pain; Neurologic Manifestations; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases