A Randomized Controlled Trial of Oral CBD for the Treatment of Upper Extremity Musculoskeletal Pain
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrent DeGeorge
About this trial
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 \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 <9/10.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Cannabidiol (CBD)
Drug25 mg capsule twice daily
Placebo
Drug25 mg capsule twice daily
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Oral CBDExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in Pain on the Visual Analog Pain (VAS) Score
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
Time frame
Baseline and Week 4, Week 62
Change from Baseline in Pain on the Visual Analog Pain (VAS) Score - Crossover Condition
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
Time frame
Baseline and Week 4, Week 63
Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score
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)
Time frame
Baseline and Week 4, Week 64
Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score - Crossover Condition
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)
Time frame
Baseline and Week 4, Week 6Secondary outcomes
1
Number of Participants With Treatment-Related Adverse Events
Treatment-related adverse events will be reported throughout the study by self-report and clinician-driven questions at each visit
Time frame
Through study completion, an average of 12 weeks2
Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure
Blood pressure (SBP and DBP) in mmHg using Sphygmomanometer will be assessed by the researchers at baseline and follow-up
Time frame
Baseline and Week 43
Change from Baseline in Heart Rate
Heartbeats per minute (BPM) will be assessed by the researchers at baseline and follow-up
Time frame
Baseline and Week 44
Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure
Blood pressure (SBP and DBP) in mmHg using Sphygmomanometer will be assessed by the researchers at baseline and follow-up
Time frame
Week 4 and Week 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Brent DeGeorge
Lead sponsor
University of Virginia
Sponsor institution
The Plastic Surgery Foundation
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: