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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabidiol | Experimental | Participants will receive 5mL syringe with Cannabidiol (Investigational drug) in it. |
|
| Placebo | No Intervention | Participants will receive 5mL syringe with Shea Butter cream (Placebo) in it. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 2 weeks and then crossover to other cream for 2 more weeks after a 1 week washout period. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| D020423 | Median Neuropathy |
| D002607 | Charcot-Marie-Tooth Disease |
| ID | Term |
|---|---|
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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|
| 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. | 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. | 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. | 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:
| 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. | 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 | 2 weeks |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D015417 | Hereditary Sensory and Motor Neuropathy |
| D009421 | Nervous System Malformations |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |