Topical Cannabidiol for Treating Carpal Tunnel Syndrome

NCT06108349 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: HSR230375
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Purpose of this study is to assess the safety and efficacy of Cannabidiol on treatment of Carpal Tunnel Syndrome.

Conditions

Carpal Tunnel Syndrome

Keywords

Distal median nerve compression; Entrapment neuropathy

Outcome Measures

Primary Outcomes (1)

• Feasibility of CBD as a topical treatment for CTS is determined by the investigator by evaluating the Recruitment Rate, medication compliance rate and retention rate.

  1. The Study PI uses recruitment materials and participant materials for enrolling the subjects. study participants will be randomized to either the treatment group or placebo group (1:1 ratio) once consent is signed and inclusion/exclusion criteria are satisfied. Recruitment rate is calculated by comparing number of patients with CTS willing to undergo randomization compared to patients offered enrollment in the trial. 2. Study medication will be dispensed to the subjects by the study team and are returned to the study team at the next visit. study drug accountability will be maintained by the research team. 3. Retention Rate will be calculated by number of patients completing the follow up visit. The investigator or designee will make every effort to regain contact with the participant.

  2 weeks and then crossover to other cream for 2 more weeks after a 1 week washout period.

Secondary Outcomes (7)

• The efficacy of CBD as a topical treatment for carpal tunnel syndrome is measured by a. Change in symptom severity as reported with the Boston Carpal Tunnel Symptom Severity Scale from baseline and study Days 14, 21 and 28.

  2 weeks

• The efficacy of CBD as a topical treatment for carpal tunnel syndrome is measured by change in patient reported outcomes measured by SANE scores from baseline and study Days 14, 21 and 28.

  2 weeks

• The efficacy of CBD as a topical treatment for carpal tunnel syndrome is measured by change in Patient reported outcomes measurement information system from baseline and study Days 14, 21 and 28.

  2 weeks

• The efficacy of CBD as a topical treatment for carpal tunnel syndrome is measured by change in VAS scores from baseline and study Days 14, 21 and 28.

  2 weeks

• Along with efficacy, safety of CBD is measured by performing set of Laboratory tests

  2 weeks

Study Arms (2)

Cannabidiol

EXPERIMENTAL

Participants will receive 5mL syringe with Cannabidiol (Investigational drug) in it.

Drug: Cannabidiol

Placebo

NO INTERVENTION

Participants will receive 5mL syringe with Shea Butter cream (Placebo) in it.

Interventions

Cannabidiol DRUG

Cannabidiol (CBD) is a non-psychoactive minor cannabinoid component of Cannabis sativa that is emerging as a treatment to mitigate pain, numbness, and tingling associated with peripheral neuropathy. CBD acts through multiple receptors to modulate central and peripheral neuropathic signaling pathways to alleviate pain.

Cannabidiol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Females of childbearing potential must have a negative urine and blood pregnancy test at Screening and a negative urine pregnancy test before study drug is administered. Females must abstain from sex or use a highly effective method of contraception during the period from Screening to administration of study drug and for 30 days after the last dose of study medication. Standard acceptable methods include abstinence or the use of a highly effective method of contraception, including; hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom with spermicide, vasectomy, intrauterine device. If females are of non-child bearing potential, they must be post-menopausal defined as: age \> 55 with no menses within the past 12 months, or history of hysterectomy, or history of bilateral oophorectomy, or bilateral tubal ligation.
• Males must consent to use a medically acceptable method of contraception throughout the entire study period and for 90 days after their last study drug application. They must agree to not donate sperm for 90 days after their last study drug application.
• Presence of clinical diagnosis of carpal tunnel syndrome with a CTS-6 score greater than 12 who have undergone electrodiagnostic testing with mild to moderate carpal tunnel syndrome

You may not qualify if:

• Subject does not speak English.
• Subject is blind.
• Severe cardiac, pulmonary, liver and /or renal disease.
• Coumadin use at time of screening.
• History of mental illness.
• Subjects who are incarcerated.
• History of drug or substance abuse.
• Pre-existing CBD or hemp based product usage.
• Prior carpal tunnel release surgery or carpal tunnel corticosteroid injection ≤ 6 months prior.
• History of constant, unremitting numbness or tingling.
• History of thenar atrophy.
• Patients with severe changes on electrodiagnostic testing.
• Patients with a concomitant diagnosis of cervical radiculopathy, peripheral neuropathy, cubital tunnel syndrome, fibromyalgia, chronic regional pain syndrome, or other upper extremity neuropathy
• Females who are pregnant, nursing or planning a pregnancy; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from Screening to the first dose of study medication and for 30 days after the last dose of study medication. Standard acceptable methods include abstinence or the use of a highly effective method of contraception, including; hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom with spermicide, vasectomy, intrauterine device.
• Any skin disease or condition, including eczema, psoriasis, melanoma, acne or contact dermatitis, scarring, imperfections, lesions, tattoos or discoloration that may affect treatment application, application site assessments, or affect absorption of the study drug.

Sponsors & Collaborators

• University of Virginia: lead

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Median Neuropathy; Charcot-Marie-Tooth Disease

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Plastic Surgeon and Assistant Professor

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 31, 2023
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 11, 2025

Record last verified: 2025-04