Fibromyalgia Clinical Trial
Official title:
A Randomized Double-blinded Placebo Controlled Trial Assessing the Effect of the Oral Cannabinoid Nabilone on Pain and Quality of Life in Patients With Fibromyalgia
Verified date | August 2011 |
Source | Winnipeg Regional Health Authority |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
The purpose of the study is to determine whether or not the drug Nabilone significantly reduces pain and improves quality of life in patients with fibromyalgia.
Status | Completed |
Enrollment | 40 |
Est. completion date | March 2007 |
Est. primary completion date | February 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - The patient meets The American College of Rheumatology (1990) criteria for the classification of fibromyalgia. [5] - 18-70 years old. - Any gender. - The patient has not received benefit from a tricyclic antidepressant, muscle relaxant, acetaminophen or non-steroidal anti-inflammatories for management of their pain. - No previous use of oral cannabinoids for pain management. Exclusion Criteria: - The patient's pain is better explained by a diagnosis other then fibromyalgia. - Abnormalities on routine baseline blood work including electrolytes, urea and creatinine, a complete blood count, and liver function tests (AST ALT GGT, Alk Phos, and LDH). Normal tests taken within 3 months prior to the study will be accepted if there is no history of acute illness since the time the blood was drawn. - Heart disease. (Cannabinoids can reduce heart rate and blood pressure) Patients with heart disease will be excluded based on a history of angina, MI or CHF as well as a clinical exam. - Schizophrenia or other Psychotic disorder - Severe liver dysfunction. (Patients will be excluded if there is an elevation of any of the baseline liver enzymes) - History of untreated non-psychotic emotional disorders. - Cognitive impairment. - Major illness in another body area. - Pregnancy. - Nursing mothers. - Patients less than 18 years old. - History of drug dependency. - A known sensitivity to marijuana or other cannabinoid agents |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Rehabilitation Hospital | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
Winnipeg Regional Health Authority | Valeant Canada Limited |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analogue Scale Pain Scores | Patient is asked to mark their pain from 0 to 10, with 0 = no pain, and 10 = worst pain imaginable | Baseline, then at week 2, 4 and 8 | No |
Primary | Number of Tender Points | Physician examines by digital palpation for pain at each of the 18 characteristic tender points for fibromyalgia. The number of tender points where pain is reported is recorded | At baseline, then at the week 2, 4 and 8 visits | No |
Primary | Average Pain Threshold | Patients are examined for pain at the 18 characteristic tender points. The results of all the sites are added and divided by 18 to give an average pain threshold | At baseline, then at the 2, 4 and 8 week visits | No |
Primary | Fibromyalgia Impact Questionaire | Self-administered questionnaire that evaluates physical function, work status, depression anxiety, sleep, pain, stiffness, fatigue and well-being. | At baseline, then again at weeks 2, 4 and 8. | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05659862 -
Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT03042728 -
Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program
|
N/A | |
Recruiting |
NCT06097091 -
Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia
|
N/A | |
Recruiting |
NCT04554784 -
Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia
|
N/A | |
Completed |
NCT03300635 -
Metabolism, Muscle Function and Psychological Factors in Fibromyalgia
|
N/A | |
Recruiting |
NCT06166563 -
Exercise, Irritable Bowel Syndrome and Fibromyalgia
|
N/A | |
Completed |
NCT03227952 -
Sensory Stimulation in Fibromyalgia
|
N/A | |
Completed |
NCT03166995 -
Postural Exercises in Women With Fibromyalgia
|
N/A | |
Recruiting |
NCT06237595 -
Vagus Nerve Stimulation in Fibromyalgia
|
N/A | |
Completed |
NCT01888640 -
Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)
|
N/A | |
Completed |
NCT03641495 -
Pain Education and Therapeutic Exercise for Fibromyalgia
|
N/A | |
Recruiting |
NCT05581628 -
FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
|
||
Active, not recruiting |
NCT05128162 -
Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia
|
Phase 2 | |
Completed |
NCT04674878 -
Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia
|
N/A | |
Active, not recruiting |
NCT04084795 -
Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia
|
N/A | |
Completed |
NCT03129906 -
Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients
|
N/A | |
Completed |
NCT05058911 -
Exposure-based Cognitive Behavior Therapy vs Traditional Cognitive Behavior Therapy for Fibromyalgia
|
N/A | |
Recruiting |
NCT04571528 -
Effectiveness of VIRTUAL FIBROWALK STUDY
|
N/A | |
Recruiting |
NCT04571853 -
New Educational Tool for FM
|
N/A |