A Randomized Controlled Trial of Oral CBD for the Treatment of Upper Extremity Musculoskeletal Pain
Overview
- Phase
- Phase 1
- Intervention
- Cannabidiol (CBD)
- Conditions
- Upper Extremity Muscle Pain
- Sponsor
- Brent DeGeorge
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change from Baseline in Pain on the Visual Analog Pain (VAS) Score
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
The goal of this clinical trial is to learn about the use of cannabidiol (CBD) capsules as a treatment for musculoskeletal pain. CBD is commonly being used as an over-the-counter treatment for musculoskeletal pain. Clinical trials have demonstrated a pain-relief benefit for hand and wrist osteoarthritis with topical CBD, however patients prefer oral CBD and no clinical trial has been performed to establish efficacy of oral CBD in humans for upper extremity musculoskeletal pain. The main questions it aims to answer are:
Is CBD more effective than placebo at relieving pain for upper extremity musculoskeletal pain ? Is CBD safe for participants with upper extremity musculoskeletal pain?
Participants will:
take 4 weeks of daily CBD capsules take 4 weeks of daily placebo capsules answer surveys about how they are feeling and functioning.
Participants will [describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items].
Detailed Description
This randomized controlled trial of CBD will investigate the therapeutic potential of CBD as an oral treatment for the treatment of pain of upper extremity musculoskeletal pain. Rationale: CBD is commonly being used as an over-the-counter treatment for musculoskeletal pain. Clinical trials have demonstrated a pain-relief benefit for hand and wrist osteoarthritis with topical CBD, however patients prefer oral CBD and no clinical trial has been performed to establish efficacy of oral CBD in humans for upper extremity musculoskeletal pain. Hypothesis: CBD is more effective than placebo for relieving pain and improving patient-reported outcomes for upper extremity musculoskeletal pain. Study Design: The study design will be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 4 weeks of the CBD or control and then crossover to the other condition for 4 additional weeks. Patients will take one oral capsule twice daily, once in the morning and once in the evening. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects.
Investigators
Brent DeGeorge
Associate Professor of Plastic Surgery
University of Virginia
Eligibility Criteria
Inclusion Criteria
- •Provision of signed and dated informed consent form.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Male or female, aged 18 years or older.
- •Daily visual analog pain score \>5/10 and \<9/
- •Duration of pain for greater than or equal to 3 months.
- •Presence of physician-diagnosed musculoskeletal pain in the upper extremities, including bone or joint-related pain, tendon or ligament-related pain, muscle-related pain, or fibromyalgia or physician-diagnosed postoperative pain in a discrete body region, limited to upper extremities.
- •For females, must be willing to use an approved form of birth control during this study. Acceptable forms of birth control:
- •Sterilization
- •IUD (intrauterine device)
- •Birth Control Patch
Exclusion Criteria
- •Subject does not speak or read English fluently.
- •Subject is blind.
- •Severe cardiac, pulmonary, liver and /or renal disease, or any other major organ dysfunction.
- •Subject with a history of symptoms (e.g., dizziness, light-headedness, blurred vision, palpitations, weakness, syncope) related to a drop in blood pressure due to postural changes.
- •Coumadin use at time of screening.
- •History of mental illness.
- •Subjects who are incarcerated.
- •Subjects who satisfy any DSM-V criteria for current psychiatric illness such as bipolar disorder, depression, anxiety, schizophrenia, psychosis, substance use disorder or any other psychiatric diagnosis
- •Subjects who have used intra-articular corticosteroids 30 days prior to screening.
- •History of drug or substance abuse.
Arms & Interventions
Oral CBD
Oral CBD 25 mg capsules taken twice each day for 4 weeks.
Intervention: Cannabidiol (CBD)
Placebo
Oral placebo capsules taken twice each day for 4 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
Change from Baseline in Pain on the Visual Analog Pain (VAS) Score
Time Frame: Baseline and Week 4, Week 6
The Visual Analog Pain (VAS) Score is a validated, self-reported subjective measure for measuring acute and chronic pain. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change = (Week (4 or 6) Score - Baseline Score).a validated, self-report
Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score - Crossover Condition
Time Frame: Baseline and Week 4, Week 6
The SANE Score is a self-reported subjective measure for measuring percentage of normal function. Possible scores range from 0 (most abnormal) to 100 (normal). Change = (Week (4 or 6) Score - Baseline Score)
Change from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score - Crossover Condition
Time Frame: Baseline and Week 4, Week 6
The PROMIS Global Health-10 is a validated, self-reported subjective measure for measuring generic health related quality of life. Possible scores range from 0 (most severe impairment) to 20 (best health). Change = (Week (4 or 6) Score - Baseline Score)
Change from Baseline in Pain on the Visual Analog Pain (VAS) Score - Crossover Condition
Time Frame: Baseline and Week 4, Week 6
The Visual Analog Pain (VAS) Score is a validated, self-reported subjective measure for measuring acute and chronic pain. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change = (Week (4 or 6) Score - Baseline Score).a validated, self-report
Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score
Time Frame: Baseline and Week 4, Week 6
The SANE Score is a self-reported subjective measure for measuring percentage of normal function. Possible scores range from 0 (most abnormal) to 100 (normal). Change = (Week (4 or 6) Score - Baseline Score)
Change from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score
Time Frame: Baseline and Week 4, Week 6
The PROMIS Global Health-10 is a validated, self-reported subjective measure for measuring generic health related quality of life. Possible scores range from 0 (most severe impairment) to 20 (best health). Change = (Week (4 or 6) Score - Baseline Score)
Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score
Time Frame: Baseline and Week 4, Week 6
The PROMIS Pain Interference is a validated, self-reported subjective measure for measuring generic health related quality of life. Possible scores range from 0 (does not interfere) to 10 (completely interferes). Change = (Week (4, 6) Score - Baseline Score)
Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score - Crossover Condition
Time Frame: Baseline and Week 4, Week 6
The PROMIS Pain Interference is a validated, self-reported subjective measure for measuring generic health related quality of life. Possible scores range from 0 (does not interfere) to 10 (completely interferes). Change = (Week (4, 6) Score - Baseline Score)
Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Score
Time Frame: Baseline and Week 4, Week 6
The PROMIS UE computer adaptive test is a validated computer adaptive test to assess upper extremity functional status. Change = (Week (4, 6) Score - Baseline Score)
Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Score - Crossover Condition
Time Frame: Baseline and Week 4, Week 6
The PROMIS UE computer adaptive test is a validated computer adaptive test to assess upper extremity functional status. Change = (Week (4, 6) Score - Baseline Score)
Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index
Time Frame: Baseline and Week 4, Week 6
The AUSCAN Index is a 15-item scale measuring pain (5 items), stiffness (1 item) and function (9 items) during the preceding 48 hours. Possible scores range from 0 (none) to 4 (extreme). Change = (Week (4, 6) Score - Baseline Score)
Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index - Crossover Condition
Time Frame: Baseline and Week 4, Week 6
The AUSCAN Index is a 15-item scale measuring pain (5 items), stiffness (1 item) and function (9 items) during the preceding 48 hours. Possible scores range from 0 (none) to 4 (extreme). Change = (Week (4, 6) Score - Baseline Score)
Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH)
Time Frame: Baseline and Week 4
The QuickDASH is a validated, self-reported 11-item scale measuring disability. Possible scores range from 0 (no disability) to 100 (most severe disability. Change = (Week 4 Score - Baseline Score)
Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH) - Crossover Condition
Time Frame: Baseline and Week 4
The QuickDASH is a validated, self-reported 11-item scale measuring disability. Possible scores range from 0 (no disability) to 100 (most severe disability. Change = (Week 4 Score - Baseline Score)
Change from Baseline in perseverance on the Brief Resilience Index (BRI)
Time Frame: Baseline and Week 4, Week 6
The BRI is a validated, self-reported 6-item validated tool to assess for resilience. Possible scores range from 1 (low resilience) to 5 (high resilience). Change = (Week (4, 6) Score - Baseline Score)
Change from Baseline in perseverance on the Brief Resilience Index (BRI) - Crossover Condition
Time Frame: Baseline and Week 4, Week 6
The BRI is a validated, self-reported 6-item validated tool to assess for resilience. Possible scores range from 1 (low resilience) to 5 (high resilience). Change = (Week (4, 6) Score - Baseline Score)
Secondary Outcomes
- Number of Participants With Treatment-Related Adverse Events(Through study completion, an average of 12 weeks)
- Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure(Week 4 and Week 6)
- Change from Baseline in Heart Rate(Week 4 and Week 6)
- Change from baseline in serum comprehensive metabolic panel (CMP) parameters: glucose, blood urea nitrogen (BUN), Creatinine, Calcium(Through study completion, an average of 12 weeks)
- Change from baseline in serum liver panel parameters: Alanine transaminase (ALT), Alkaline phosphatase (ALP) and Aspartate aminotransferase (AST)(Through study completion, an average of 12 weeks)
- Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Chloride(Through study completion, an average of 12 weeks)
- Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Sodium, Potassium, Chloride, Carbon Dioxide(Through study completion, an average of 12 weeks)
- Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Bilirubin(Through study completion, an average of 12 weeks)
- Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Prothrombin time- International normalized ratio (PT-INR)(Through study completion, an average of 12 weeks)
- Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Protein, Albumin(Through study completion, an average of 12 weeks)
- Change from baseline in serum complete blood count (CBC) parameters: Red Blood Cells (CBC), White Blood Cells (WBC), Platelets(Through study completion, an average of 12 weeks)
- Change from baseline in serum complete blood count (CBC) parameters: Hemoglobin(Through study completion, an average of 12 weeks)
- Change from baseline in serum complete blood count (CBC) parameters: Hematocrit(Through study completion, an average of 12 weeks)
- Change from baseline in serum complete blood count (CBC) parameters: Mean Corpuscular Volume (MCV)(Through study completion, an average of 12 weeks)
- Change from baseline in serum complete blood count (CBC) parameters: the amount of hemoglobin per red blood cell.(MCH)(Through study completion, an average of 12 weeks)