Cannabidiol (CBD)
25 mg capsule twice daily
Green Valley Nutrition, LLC · CannabidiolLoading study record…
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 \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2025-04-09
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
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.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Research network
Interventions
25 mg capsule twice daily
Green Valley Nutrition, LLC · Cannabidiol25 mg capsule twice daily
Eligibility
primary outcomes
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
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
Time frame: Through study completion, an average of 12 weeks
Treatment-related adverse events will be reported throughout the study by self-report and clinician-driven questions at each visit
Time frame: Baseline and Week 4
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 4
Heartbeats per minute (BPM) will be assessed by the researchers at baseline and follow-up
Time frame: Week 4 and Week 6
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 6
Heartbeats per minute (BPM) will be assessed by the researchers at baseline and follow-up
Time frame: Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: glucose, BUN, Creatinine, Calcium (mg/dL) at baseline and follow up
Time frame: Through study completion, an average of 12 weeks
Change from baseline in serum liver panel parameters: ALT, ALP and AST (International units per liter) at baseline and follow up
Time frame: Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Chloride (umol/L) at baseline and follow up
Time frame: Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Sodium, Potassium, Chloride, Carbon Dioxide (meq/L) at baseline and follow up
Time frame: Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Bilirubin (umol/L) at baseline and follow up
Time frame: Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Prothrombin time- International normalized ratio (PT (seconds)-INR) at baseline and follow up
Time frame: Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Protein, Albumin (g/dL) at baseline and follow up
Time frame: Through study completion, an average of 12 weeks
Change from baseline in serum complete blood count (CBC) parameters: RBC, WBC, Platelets (uL) at baseline and follow up
Time frame: Through study completion, an average of 12 weeks
Change from baseline in serum complete blood count (CBC) parameters: Hemoglobin (g.dL) at baseline and follow up
Time frame: Through study completion, an average of 12 weeks
Change from baseline in serum complete blood count (CBC) parameters: Hematocrit (percentage) at baseline and follow up
Time frame: Through study completion, an average of 12 weeks
Change from baseline in serum complete blood count (CBC) parameters: Mean Corpuscular Volume (MCV) (pg) at baseline and follow up
Time frame: 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) (pg) at baseline and follow up
Publications