Fibromyalgia Clinical Trial
— CANNFIBOfficial title:
Cannabidiol for Fibromyalgia -The CANNFIB Trial Protocol for a Randomized, Double-blind, Placebo-controlled, Parallel-group, Single-center Trial
Verified date | March 2024 |
Source | Frederiksberg University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Fibromyalgia is serious chronic pain condition which is often accompanied by sleep disturbances, fatigue and disability and reduced quality of life. There is no cure and treatments are based on reliving symptoms and maintaining function. The currently available medical treatments are not helping many patients, and many get side-effects. Medical cannabis is sought after among patients and many use this medication un-licenced, although it is not properly documented if it works or is safe. Therefore, it is necessary to investigate the effects and safety of medical cannabis in a properly designed randomized trial. The aim of the study is to investigate if cannabidiol (CBD) can improve pain, sleep, function and quality of life in patients with fibromyalgia. The study will include 200 patients, who will receive either cannabidiol or placebo over a period of 24 weeks. Participants will be closely looked after for improvements in their condition and for potential side-effects to ensure safety.
Status | Completed |
Enrollment | 200 |
Est. completion date | February 14, 2024 |
Est. primary completion date | February 14, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Informed consent obtained - Clinical diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) 1990 criteria - Average pain intensity = 4 on a Numeric Rating Scale - No use of medical cannabis (THC/CBD) within the last six months - Proficiency in spoken Danish language and able to read and write in Danish Exclusion Criteria: - On-going participation in other medical trials for pain management of fibromyalgia - Diagnosis of Rheumatoid Arthritis or other inflammatory diseases - Diagnosis of other serious chronic diseases - Impaired liver and kidney function - Pregnancy or insufficient anti-conception therapy for fertile female participants - Planning pregnancy or insufficient anti-conception use in fertile female partners of male participants - Breast feeding - Surgery scheduled for the trial period or within 3 months prior to enrollment - History of or current diagnosis of cancer - History of or current epilepsy and seizures - History of or major depressive disorder - History of a suicide attempt or any suicidal behavior - A mental state that may impede compliance with the program - History of severe psychiatric disorders - History of or current cannabis abuse - History of or current drug abuse - History of or current alcohol abuse - Severe personality disorder - Current use of opioids, opioid antagonists (LDN) or similar strong analgesics - Allergic reactions to the active ingredients in cannabidiol |
Country | Name | City | State |
---|---|---|---|
Denmark | The Parker Institute, Frederiksberg Hospital | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Marius Henriksen |
Denmark,
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* Note: There are 63 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Sleep latency | Change in sleep latency, measured with the Pittsburgh Sleep Quality Index; sleep latency domain, scored on an 0-3 interval scale, on which 0 is indicating more problems with sleep latency and higher score less problems with sleep latency. | From baseline to week 24 and from baseline to week 36 | |
Other | Pain self-efficacy | Change in pain self-efficacy, measured with the Pain Self-Efficacy Questionnaire, consisting of 10 items from 0 to 6 yielding a total score from 0 to 60. Lower scores are indicating lower levels of pain self-efficacy and higher scores are indicating higher levels of pain self-efficacy. | From baseline to week 24 and from baseline to week 36 | |
Other | Stiffness | Change in stiffness, measured with the Fibromyalgia Impact Questionnaire Revised; stiffness subscale, which is an 11- point numieric rating scale of 0-10, with 10 being the worst outcome indicating the highest level of stiffness, and lower scores indicating less stiffness. | From baseline to week 24 and from baseline to week 36 | |
Other | Energy level | Change in energy, measured with the Fibromyalgia Impact Questionnaire Revised; energy subscale, which is an 11- point numeric rating scale of 0-10, with10 being the worst outcome, indicating the lowest level of energy, and lower scores indicating higher levels of energy. | From baseline to week 24 and from baseline to week 36 | |
Other | Objectively measured physical activity | Change in objectively measured physical activity, measured with the Sens triaxial accelerometer device; MOTION® activity and sleep measurement system, in which the number of minutes of physical activity are calculated during a week of measurement. | From baseline to week 24 | |
Other | Feeling rested | Change in feeling rested, measured with the Fibromyalgia Impact Questionnaire Revised; rested subscale, which is an 11- point numeric rating scale of 0-10, with 10 being the worst outcome indicating not feeling rested, and lower scores indicating feeling more rested. | From baseline to week 24 and from baseline to week 36 | |
Other | Depression | Change in depression, measured with the Fibromyalgia Impact Questionnaire Revised; depression subscale, which is an 11- point numeric rating scale of 0-10, with 10 being the worst outcome indicating depression, and lower scores indicating less depression, and the Depression, Anxiety, Stress Scale (DASS), depression subscales, which include 7 items scored from 0 to 3 to a maximum of 21 indicating the worst outcome as higher scores indicate more depression and lower scores less depression. | From baseline to week 24 and from baseline to week 36 | |
Other | Anxiety | Change in anxiety, measured with the Fibromyalgia Impact Questionnaire Revised; anxiety subscale, which is an 11- point numeric rating scale of 0-10, with 10 being the worst outcome indicating more anxiety, and lower scores indicating less anxiety, and the Depression, Anxiety, Stress Scale (DASS), anxiety subscales, which include 7 items scored from 0 to 3 to a maximum of 21 indicating the worst outcome as higher scores indicate more anxiety and lower scores less anxiety. | From baseline to week 24 and from baseline to week 36 | |
Other | Perceived stress | Change in perceived stress, measured with the Fibromyalgia Impact Questionnaire Revised; stress subscale, which is an 11- point numeric rating scale of 0-10, with 10 being the worst outcome indicating more stress, and lower scores indicating less stress, and the Depression, Anxiety, Stress Scale (DASS), stress subscales, which include 7 items scored from 0 to 3 to a maximum of 21 indicating the worst outcome as higher scores indicate more stress and lower scores less stress. | From baseline to week 24 and from baseline to week 36 | |
Other | Cortisol concentration in hair | Change in cortisol concentration in hair, with hair clipping analysis as a biomarker for prolonged stress. Higher cortisol concentration in hair is indicating higher stress levels. | From baseline to week 24 | |
Other | Memory problems | Change in memory problems, measured with the Fibromyalgia Impact Questionnaire Revised; memory subscale, which is an 11- point numeric rating scale of 0-10, with 10 being the worst outcome indicating more memory problems, and lower scores indicating less memory problems. | From baseline to week 24 and from baseline to week 36 | |
Other | Tenderness level | Change in tenderness level, measured with the Fibromyalgia Impact Questionnaire Revised; tenderness subscale, which is an 11- point numeric rating scale of 0-10, with 10 being the worst outcome indicating more tenderness, and lower scores indicating less tenderness. | From baseline to week 24 and from baseline to week 36 | |
Other | Balance problems | Change in balance problems, measured with the Fibromyalgia Impact Questionnaire Revised; balance subscale, which is an 11- point numeric rating scale of 0-10, with 10 being the worst outcome indicating more balance problems, and lower scores indicating less balance problems. | From baseline to week 24 and from baseline to week 36 | |
Other | Environmental sensitivity | Change in environmental sensitivity, measured with the Fibromyalgia Impact Questionnaire Revised; environmental sensitivity subscale, which is an 11- point numeric rating scale of 0-10, with 10 being the worst outcome indicating more environmental sensitivity, and lower scores indicating less environmental sensitivity, and the Fibromyalgia Sensory Hypersensitivity Scale, which is 9 item scale ranging from 0-3 with the maximum score of 27 being the worst outcome indicating the highest level of environmental sensitivity and lower levels indicating less environmental sensitivity. | From baseline to week 24 and from baseline to week 36 | |
Other | Pressure pain threshold and tolerance | Change in pressure pain threshold and tolerance, measured with computerized cuff pressure algometry. Pain threshold is defined as the pressure of the cuff at the subjects first sensation of pain when applying constantly rising pressure. Pain tolerance is defined as the worst tolerable pain caused by the pressure stimulation and the pressure is switched off by the patient. Lower pressures indicates low pressure pain threshold and tolerance, and higher pressures indicates higher pain threshold and tolerance. | From baseline to week 24 | |
Other | Muscle fatiguability | Change in muscle fatiguability, measured with a static muscle exhaustion test performed during which surface electromyography is recorded. The more muscle exhaustion detected, the more muscle fatiguability. | From baseline to week 24 | |
Other | Appetite | Change in appetite, measured with the Simplified Nutritional Appetite Questionnaire, which is a 5 item scale each ranging from 1 to 5, yielding a maximun score of 25. Higher scores are indicating a greater appetite and lower scores are indicating reduced appetite. | From baseline to week 24 and from baseline to week 36 | |
Other | Body weight | Change in body weight, measured using an electronic scale. | From baseline to week 24 and from baseline to week 36 | |
Other | Body composition | Change in body composition, measured by the bioimpedance measurement conducted using the device named Impedimed model Sfb7, which measures impedance (resistance) through weak electric current flowing through body tissues over a spectrum of frequencies, to detect different body compositions such as body fat and muscle mass, total body water and fat free body mass. | From baseline to week 24 | |
Other | Waist circumference | Change in waist circumference, will be measured using a tape measure to the nearest 0.1 cm. as a measure of body fat distribution. | From baseline to week 24 | |
Other | Hip circumference | Change in hip circumference, will be measured using a tape measure to the nearest 0.1 cm. as a measure of body fat distribution. | From baseline to week 24 | |
Other | Pain intensity | Change in pain intensity, measured with the 0-10 pain Numeric Rating Scale (NRS) item from the Fibromyalgia Impact Questionnaire Revised. The minimum value is 0, which is the best outcome, indicating no pain. The maximum value is 10, which is the worst outcome, indicating the worst possible pain. | From baseline to week 36 | |
Other | Sleep quality | Change in sleep quality, measured with the Pittsburgh Sleep Quality Index; total score to measure overall sleep quality. Scores are ranging from 0 to 21, with lower scores indictating a better sleep quality and higher scores a worse sleep quality. | From baseline to week 36 | |
Other | Sleep duration | Change in sleep duration, measured with the Pittsburgh Sleep Quality Index; sleep duration domain, with number of hours of actual sleep during the night. | From baseline to week 36 | |
Other | Activities of daily living | Change in activities of daily living, measured with the Activities of Daily Living Questionnaire, in which items are rated on a 4 point Likert scale from 0= no problem to 3=no longer able to complete the task. Scores are calculated for total and subscale scores and expressed as a percentage from 0 to 100%. A lower scores percentage indicates a higher level of ADL, and higher percentage indicates a lower level of ADL. | From baseline to week 36 | |
Other | Health-related quality of life | Change in quality of life, measured with the EuroQol Self-Rated Health Questionnaire, developed by the EuroQual group and international network of multidisciplinary researchers.The scores goes from 0 -100, with 0 indicating the worst possible health condition and 100 indicating the best possible health condition. | From baseline to week 36 | |
Primary | Pain intensity | The primary endpoint is change in pain intensity, measured with the 0-10 pain numeric rating scale, from the Fibromyalgia Impact Questionnaire Revised. The minimum value is 0, which is the best outcome, indicating no pain. The maximum value is 10, which is the worst outcome, indicating the worst possible pain. | From baseline to week 24 | |
Secondary | Sleep quality | The first of six key secondary outcomes is change in sleep quality, measured with the Pittsburgh Sleep Quality Index; total score of overall sleep quality. Scores are ranging from 0 to 21, with lower scores indicating better sleep quality and higher scores indicating worse sleep quality. | From baseline to week 24 | |
Secondary | Sleep duration | The second of six key secondary outcomes is change in sleep duration, measured with the Pittsburgh Sleep Quality Index; sleep duration domain, with number of hours of actual sleep during the night. | From baseline to week 24 | |
Secondary | Objectively measured sleep duration | The third of six key secondary outcomes is change in objectively measured sleep duration, with number of hours of nightly sleep, measured with the Sens triaxial accelerometer device; MOTION® activity and sleep measurement system. | From baseline to week 24 | |
Secondary | Objectively measured sleep patterns | The fourth of six key secondary outcomes is change in objectively measured sleep patterns, measured with the Sens triaxial accelerometer device; MOTION® activity and sleep measurement system, in which the different sleep phases during the night are indicated. | From baseline to week 24 | |
Secondary | Activities of daily living | The fifth of six key secondary outcomes is change in Activities of Daily Living (ADL), measured with the Assessment of Motor and process skills (AMPS) test, which is an observation-based, standardized evaluation of the individual's ability to perform and complete activities of daily living. The measure is based on 16 ADL motor skills and 20 ADL process skills. Scores range from 0 to 4 on an ordinal scale, with 0 indicating the lowest level of ADL and 4 indicating the highest ADL level. Activities of daily living is also measured with the Activities of Daily Living Questionnaire, in which items are rated on a 4 point Likert scale from 0= no problem to 3=no longer able to complete the task. Scores are calculated for total and subscale scores and expressed as a percentage from 0 to 100%. Lower percentage indicates a higher ADL level, and higher percentage indicates a lower ADL level. | From baseline to week 24 | |
Secondary | Health-related quality of life | The sixth of six key secondary outcomes is change in quality of life, measured with the EuroQol Self-Rated Health Questionnaire, developed by the EuroQual group and international network of multidisciplinary researchers.The scores goes from 0 -100, with 0 indicating the worst possible health condition and 100 indicating the best possible health condition. | From baseline to week 24 |
Status | Clinical Trial | Phase | |
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Active, not recruiting |
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