Oral CBD for Upper Extremity Musculoskeletal Pain

This study is testing if oral cannabidiol (CBD) capsules can help reduce musculoskeletal pain in your upper body (arms, shoulders, hands). Many people use CBD for pain, but there isn't much research on how well oral CBD works for this specific type of pain. This trial aims to see if taking 25 mg CBD capsules twice daily is more effective than a placebo (an inactive capsule) and if it's safe. You might be able to join if you are 18 or older, have had upper extremity pain for at least 3 months, and your pain level is consistently between 5 and 9 out of 10. The study is currently recruiting about 100 participants.

Study design
This is a randomized, double-blind study with a crossover design, meaning you will receive either CBD or a placebo for 4 weeks, then switch to the other for another 4 weeks. Neither you nor the study staff will know which treatment you are receiving at any given time.
What's involved
You will take one oral capsule twice daily for a total of 8 weeks. Your pain and normal function will be measured at the start, at 4 weeks, and at 6 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your pain and function will be measured up to 6 weeks into the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06695195

A Randomized Controlled Trial of Oral CBD for the Treatment of Upper Extremity Musculoskeletal Pain

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
Brent DeGeorge
~100 participants
Updated 2025-04-09 on ClinicalTrials.gov
What's tested:Cannabidiol (CBD)Placebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in Pain on the Visual Analog Pain (VAS) Score
Measured over Baseline and Week 4, Week 6
+15 more outcomes measured
Upper Extremity Muscle Pain
Upper Extremity Bone Pain
Upper Extremity Pain
1 sites across 1 states
Virginia1
  • Brent DeGeorge, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Virginia Department of Plastic Surgery

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Eligibility criteria

Inclusion

Norplant
Sterilization
IUD (intrauterine device)
Birth Control Patch
Depo-Provera
Condoms
Diaphragm
Jellies or foam
Sponge
Cervical cap 8. For males, must be willing to not father a baby for the duration of the study and for 90 days after the last dose of study drug, or donate to a sperm bank during this time. Must be willing to use an approved form of birth control during this time. Acceptable forms of birth control:
Condoms
Sterilization

Exclusion

ALT \>5x ULN or total bilirubin\>2×ULN
ALT or AST\>3 × ULN and total bilirubin\>2xULN or INR \>1.5 17. Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP3A4 :
Itraconazole,
Ketoconazole,
Azamulin,
Troleandomycin,
Verapamil,
John's wart,
Phenobarbital, 18. Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP2C19:
Nootkatone,
Ticlopidine,
Rifampin,
Omeprazole), 19. Subjects taking prescription or non-prescription medication which are substrates of CYP2C8:
Montelukast,
Quercetin,
Phenelzine,
Rifampin,
Clopidogrel) , 20. Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates ofCYP2C9:
Sulfaphenazole,
Tienilic acid,
Carbamazepine,
Apalutamide,
Fluconazole,
Celecoxib 21. Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP1A2:
alpha-Naphthoflavone,
Furafylline,
Phenytoin,
Rifampin,
Ritonavir,
smoking,
Teriflunomide,
Ciproflaoxacin,
oral contraceptives,
Allopurinol 22. Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP2B6:
Sertraline,
Phencyclidine,
Thiotepa,
Ticlopidine,
Carbamazepine,
Efavirenez,
Rifampin,
Bupropion.
  • Change from Baseline in Pain on the Visual Analog Pain (VAS) ScoreBaseline 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 Pain on the Visual Analog Pain (VAS) Score - Crossover ConditionBaseline 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) ScoreBaseline 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 Normal Function on the Single Assessment Numerical Evaluation (SANE) Score - Crossover ConditionBaseline 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 ScoreBaseline 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 Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score - Crossover ConditionBaseline 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 ScoreBaseline 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 ConditionBaseline 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) ScoreBaseline 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 ConditionBaseline 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) IndexBaseline 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 ConditionBaseline 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)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 ConditionBaseline 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)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 ConditionBaseline 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)