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Upper Extremity Muscle PainPhase 1NCT06695195

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

A Phase 1 study testing Cannabidiol (CBD) in people with Upper Extremity Muscle Pain and Upper Extremity Bone Pain, run by Brent DeGeorge at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cannabidiol (CBD)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteUnited States
Study dates
Jun 2025to Mar 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
Show all 21Show fewer
  • For females, must be willing to use an approved form of birth control during this study. Acceptable forms of birth control:
  • Norplant
  • Sterilization
  • IUD (intrauterine device)
  • Birth Control Patch
  • Depo-Provera
  • The following may be used if combined with other birth control methods:
  • Condoms
  • Diaphragm
  • Jellies or foam
  • Sponge
  • Cervical cap
  • 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

Who cannot join

  • 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.
Show all 64Show fewer
  • 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.
  • Pre-existing CBD product usage currently (or within the prior 3 months) using recreational or medicinal cannabis, any cannabinoid-based medications, and is unwilling to abstain for the duration of the study.
  • Subject has had a corticosteroid injection ≤ 60 days prior.
  • Subjects who are unwilling to agree to no opioid medications or topical analgesic medications during the study period.
  • Any woman of child bearing potential or male patient's partner unwilling to ensure that they or their partner use effective contraception, for example, hormonal contraception, double barrier, intra-uterine device, during the study and for females, through 30 days thereafter, and for males, three months thereafter.
  • Any male not willing to avoid donating sperm during the duration of the study treatment period and for three months thereafter.
  • Any patient with aberrant liver function as defined by either of the following:
  • ALT >5x ULN or total bilirubin>2×ULN
  • ALT or AST>3 × ULN and total bilirubin>2xULN or INR >1.5
  • 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,
  • Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP2C19:
  • Nootkatone,
  • Ticlopidine,
  • Rifampin,
  • Omeprazole),
  • Subjects taking prescription or non-prescription medication which are substrates of CYP2C8:
  • Montelukast,
  • Quercetin,
  • Phenelzine,
  • Rifampin,
  • Clopidogrel) ,
  • 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
  • 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
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lindsey Wilkin, BS contact

571-225-8756

lm26z@virginia.edu

United States1 site

  • University of Virginia

    Charlottesville, Virginia, 22903

    Lindsey Wilkin, BS, 571-225-8756, lm26z@virginia.edu

    Brent DeGeorge, MD, PhD

Other trials in United States

About this study

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?

Read more

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].

Read the 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.

Being tested
Cannabidiol (CBD), Placebo
Keywords
Wrist Muscular Pain, Forearm Bone Pain, Forearm Muscular Pain, Hand Pain, CBD, oral CBD, Upper Arm Muscular Pain, Upper Arm Bone Pain, Wrist Joint Pain, Wrist Bone Pain, Forearm Joint Pain, Upper Arm Joint Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cannabidiol (CBD)Drug

    Also called Green Valley Nutrition, LLC, Cannabidiol

    25 mg capsule twice daily

  • PlaceboDrug

    25 mg capsule twice daily

Study groups in NCT06695195
Study groupRoleWhat they receive
Oral CBDExperimentalOral CBD 25 mg capsules taken twice each day for 4 weeks.
Receives: Drug: Cannabidiol (CBD)
PlaceboPlacebo comparatorOral placebo capsules taken twice each day for 4 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline and Week 4, Week 6

  2. 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

    Measured: Baseline and Week 4, Week 6

  3. 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)

    Measured: Baseline and Week 4, Week 6

  4. 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)

    Measured: Baseline and Week 4, Week 6

  5. Change from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score

    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)

    Measured: Baseline and Week 4, Week 6

  6. Change from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score - Crossover Condition

    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)

    Measured: Baseline and Week 4, Week 6

  7. Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score

    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)

    Measured: Baseline and Week 4, Week 6

  8. Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score - Crossover Condition

    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)

    Measured: Baseline and Week 4, Week 6

  9. Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Score

    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)

    Measured: Baseline and Week 4, Week 6

  10. Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Score - Crossover Condition

    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)

    Measured: Baseline and Week 4, Week 6

  11. Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index

    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)

    Measured: Baseline and Week 4, Week 6

  12. Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index - Crossover Condition

    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)

    Measured: Baseline and Week 4, Week 6

  13. Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH)

    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)

    Measured: Baseline and Week 4

  14. Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH) - Crossover Condition

    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)

    Measured: Baseline and Week 4

  15. Change from Baseline in perseverance on the Brief Resilience Index (BRI)

    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)

    Measured: Baseline and Week 4, Week 6

  16. Change from Baseline in perseverance on the Brief Resilience Index (BRI) - Crossover Condition

    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)

    Measured: Baseline and Week 4, Week 6

Secondary outcomes (17)

  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

    Measured: Through study completion, an average of 12 weeks

  2. 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

    Measured: Baseline and Week 4

  3. Change from Baseline in Heart Rate

    Heartbeats per minute (BPM) will be assessed by the researchers at baseline and follow-up

    Measured: Baseline and Week 4

  4. 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

    Measured: Week 4 and Week 6

  5. Change from Baseline in Heart Rate

    Heartbeats per minute (BPM) will be assessed by the researchers at baseline and follow-up

    Measured: Week 4 and Week 6

  6. Change from baseline in serum comprehensive metabolic panel (CMP) parameters: glucose, blood urea nitrogen (BUN), Creatinine, Calcium

    Change from baseline in serum comprehensive metabolic panel (CMP) parameters: glucose, BUN, Creatinine, Calcium (mg/dL) at baseline and follow up

    Measured: Through study completion, an average of 12 weeks

  7. Change from baseline in serum liver panel parameters: Alanine transaminase (ALT), Alkaline phosphatase (ALP) and Aspartate aminotransferase (AST)

    Change from baseline in serum liver panel parameters: ALT, ALP and AST (International units per liter) at baseline and follow up

    Measured: Through study completion, an average of 12 weeks

  8. Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Chloride

    Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Chloride (umol/L) at baseline and follow up

    Measured: Through study completion, an average of 12 weeks

  9. Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Sodium, Potassium, Chloride, Carbon Dioxide

    Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Sodium, Potassium, Chloride, Carbon Dioxide (meq/L) at baseline and follow up

    Measured: Through study completion, an average of 12 weeks

  10. Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Bilirubin

    Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Bilirubin (umol/L) at baseline and follow up

    Measured: Through study completion, an average of 12 weeks

  11. Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Prothrombin time- International normalized ratio (PT-INR)

    Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Prothrombin time- International normalized ratio (PT (seconds)-INR) at baseline and follow up

    Measured: Through study completion, an average of 12 weeks

  12. Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Protein, Albumin

    Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Protein, Albumin (g/dL) at baseline and follow up

    Measured: Through study completion, an average of 12 weeks

  13. Change from baseline in serum complete blood count (CBC) parameters: Red Blood Cells (CBC), White Blood Cells (WBC), Platelets

    Change from baseline in serum complete blood count (CBC) parameters: RBC, WBC, Platelets (uL) at baseline and follow up

    Measured: Through study completion, an average of 12 weeks

  14. Change from baseline in serum complete blood count (CBC) parameters: Hemoglobin

    Change from baseline in serum complete blood count (CBC) parameters: Hemoglobin (g.dL) at baseline and follow up

    Measured: Through study completion, an average of 12 weeks

  15. Change from baseline in serum complete blood count (CBC) parameters: Hematocrit

    Change from baseline in serum complete blood count (CBC) parameters: Hematocrit (percentage) at baseline and follow up

    Measured: Through study completion, an average of 12 weeks

  16. Change from baseline in serum complete blood count (CBC) parameters: Mean Corpuscular Volume (MCV)

    Change from baseline in serum complete blood count (CBC) parameters: Mean Corpuscular Volume (MCV) (pg) at baseline and follow up

    Measured: Through study completion, an average of 12 weeks

  17. Change from baseline in serum complete blood count (CBC) parameters: the amount of hemoglobin per red blood cell.(MCH)

    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

    Measured: Through study completion, an average of 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2024
  2. Study startJun 2025 (estimated)
  3. Primary completionMar 2026 (estimated)
  4. Study completionMar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
The study design will be a double-blind, randomized controlled trial with crossover.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06695195
Sponsor's protocol ID
301881
Status last verified
Dec 2024
First submitted
15 Nov 2024
Last updated
9 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Russo E.B., Mathre M.L., Byrne A., Velin R., Bach P.J., Sanchez-Ramos J., et. al.: Chronic cannabis use in the compassionate investigational new drug program: an examination of benefits and adverse effects of legal clinical cannabis. J Cannabis Ther 2002; 2: pp. 3-57.

  • Stockings E, Zagic D, Campbell G, Weier M, Hall WD, Nielsen S, Herkes GK, Farrell M, Degenhardt L. Evidence for cannabis and cannabinoids for epilepsy: a systematic review of controlled and observational evidence. J Neurol Neurosurg Psychiatry. 2018 Jul;89(7):741-753. doi: 10.1136/jnnp-2017-317168. Epub 2018 Mar 6.

    PubMed 29511052

  • Bruni N, Della Pepa C, Oliaro-Bosso S, Pessione E, Gastaldi D, Dosio F. Cannabinoid Delivery Systems for Pain and Inflammation Treatment. Molecules. 2018 Sep 27;23(10):2478. doi: 10.3390/molecules23102478.

    PubMed 30262735

  • Fader L, Scharf Z, DeGeorge BR Jr. Assessment of Medical Cannabis in Patients With Osteoarthritis of the Thumb Basal Joint. J Hand Surg Am. 2023 Mar;48(3):257-262.e1. doi: 10.1016/j.jhsa.2021.10.018. Epub 2021 Dec 8.

    PubMed 34893392

  • Ware MA, Wang T, Shapiro S, Collet JP; COMPASS study team. Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS). J Pain. 2015 Dec;16(12):1233-1242. doi: 10.1016/j.jpain.2015.07.014. Epub 2015 Sep 16.

    PubMed 26385201

  • Heineman JT, Forster GL, Stephens KL, Cottler PS, Timko MP, DeGeorge BR Jr. A Randomized Controlled Trial of Topical Cannabidiol for the Treatment of Thumb Basal Joint Arthritis. J Hand Surg Am. 2022 Jul;47(7):611-620. doi: 10.1016/j.jhsa.2022.03.002. Epub 2022 May 28.

    PubMed 35637038

  • MacCallum CA, Russo EB. Practical considerations in medical cannabis administration and dosing. Eur J Intern Med. 2018 Mar;49:12-19. doi: 10.1016/j.ejim.2018.01.004. Epub 2018 Jan 4.

    PubMed 29307505

  • Arzimanoglou A, Brandl U, Cross JH, Gil-Nagel A, Lagae L, Landmark CJ, Specchio N, Nabbout R, Thiele EA, Gubbay O, The Cannabinoids International Experts Panel; Collaborators. Epilepsy and cannabidiol: a guide to treatment. Epileptic Disord. 2020 Feb 1;22(1):1-14. doi: 10.1684/epd.2020.1141.

    PubMed 32096470

  • Chen JW, Borgelt LM, Blackmer AB. Cannabidiol: A New Hope for Patients With Dravet or Lennox-Gastaut Syndromes. Ann Pharmacother. 2019 Jun;53(6):603-611. doi: 10.1177/1060028018822124. Epub 2019 Jan 8.

    PubMed 30616356

  • Mechoulam R, Hanus L. Cannabidiol: an overview of some chemical and pharmacological aspects. Part I: chemical aspects. Chem Phys Lipids. 2002 Dec 31;121(1-2):35-43. doi: 10.1016/s0009-3084(02)00144-5.

    PubMed 12505688

  • Baron EP, Lucas P, Eades J, Hogue O. Patterns of medicinal cannabis use, strain analysis, and substitution effect among patients with migraine, headache, arthritis, and chronic pain in a medicinal cannabis cohort. J Headache Pain. 2018 May 24;19(1):37. doi: 10.1186/s10194-018-0862-2.

    PubMed 29797104

  • Brat GA, Agniel D, Beam A, Yorkgitis B, Bicket M, Homer M, Fox KP, Knecht DB, McMahill-Walraven CN, Palmer N, Kohane I. Postsurgical prescriptions for opioid naive patients and association with overdose and misuse: retrospective cohort study. BMJ. 2018 Jan 17;360:j5790. doi: 10.1136/bmj.j5790.

    PubMed 29343479

  • Wolf JM, Atroshi I, Zhou C, Karlsson J, Englund M. Sick Leave After Surgery for Thumb Carpometacarpal Osteoarthritis: A Population-Based Study. J Hand Surg Am. 2018 May;43(5):439-447. doi: 10.1016/j.jhsa.2017.11.019. Epub 2018 Feb 7.

    PubMed 29428245

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cannabidiol (CBD) in people with Upper Extremity Muscle Pain and Upper Extremity Bone Pain, run by Brent DeGeorge at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 64 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lindsey Wilkin, BS (571-225-8756, lm26z@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Pain on the Visual Analog Pain (VAS) Score (time frame: Baseline and Week 4, Week 6). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06695195, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.

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