A Phase 2 interventional study of Cannabidiol in Carpal Tunnel Syndrome, sponsored by University of Virginia. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-11.
Sponsored by University of Virginia · Phase 2, Interventional, and Treatment
The Purpose of this study is to assess the safety and efficacy of Cannabidiol on treatment of Carpal Tunnel Syndrome.
Carpal tunnel syndrome (CTS), or compression neuropathy of the median nerve at the wrist, is the most common entrapment neuropathy affecting up to 15% of the general population Non-operative interventions for CTS include night-time splinting, physical therapy, and corticosteroid administration, however only surgery is considered a definitive treatment for CTS. There is an unmet need for novel, effective non-operative options for the treatment of CTS to provide care for patients who cannot undergo surgery for medical reasons or do not feel comfortable proceeding with a surgical option.
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. Pre-clinical data indicates that CBD acts through multiple receptors to modulate central and peripheral neuropathic signaling pathways to alleviate pain - specifically in pre-clinical models of compression neuropathy as in CTS. This pilot trial seeks to investigate whether CBD is a safe, feasible, and effective treatment for CTS in patients with confirmed mild to moderate CTS receiving standardized physiotherapy with primary endpoints assessing feasibility, symptom severity, and/or disability and also highlights the gap in knowledge regarding the clinical utility of cannabinoids
589 studies on the registry are indexed under Carpal Tunnel Syndrome; 139 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive 5mL syringe with Cannabidiol (Investigational drug) in it.
Drug: Cannabidiol
Participants will receive 5mL syringe with Shea Butter cream (Placebo) in it.
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.
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.
Time frame: 2 weeks and then crossover to other cream for 2 more weeks after a 1 week washout period.
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.
The Boston Carpal Tunnel Score is a patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. The Symptom Severity Scale (SSS) with 11 questions is scored on a Likert scale of 1-5 and the Functional Status Scale (FSS) with 8 questions is scored from 1-5 with 1 as no difficulty and 5 as difficult from Baseline and Study Days 14, 21 and 28.
Time frame: 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.
SANE Score: Single Assessment Numerical Evaluation (SANE) is a validated metric for musculoskeletal pain which can be applied to any joint or region of interest. This assessment will be performed at Baseline and Study Days 14, 21 and 28. The physician will ask the subject each question and record the response on the source document.
Time frame: 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.
The PROMIS 10 consists of ten (10) items that measure physical health, physical functioning, general mental health, emotional distress, satisfaction with social activities and relationships, ability to carry out usual social activities and roles, pain, fatigue and overall quality of life.
Time frame: 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.
VAS Scores: The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). It is assessed from baseline and study Days 14, 21 and 28.
Time frame: 2 weeks
Along with efficacy, safety of CBD is measured by performing set of Laboratory tests
Laboratory Testing: At Screening a blood draw will be performed on all female subjects of childbearing age. The following tests will be ordered: * Pregnancy Testing (if applicable) (Screening only) * Urine Pregnancy Test (if applicable) (Screening and Day 0 before dosing only)
Time frame: 2 weeks
Safety of CBD is measured by collecting relevant Medical History as a part of safety assessment.
Medical History: Relevant medical history, including history of mental illness, drug or substance abuse, history of hemp-based product usage and other pertinent history will be recorded in the case report form.
Time frame: 2 weeks
Safety of CBD is measured by performing skin monitoring tests and physical examination.
Investigator will assess the CBD cream site for adverse events at baseline and at every subsequent visit. A score will be given corresponding to the assessment tool. If the score is "0"- No erythema If the score is "1"- Minimal erythema If the score is "2"- Moderate erythema with sharply defined borders If the score is "3"- Intense erythema with or without edema If the score is "4"- Intense erythema with edema and blistering/erosion
Time frame: 2 weeks
No study locations are listed for this record.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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University of Virginia