A Randomized Controlled Trial of Topical Cannabidiol for the Treatment of Carpal Tunnel Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- 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.
研究概览
简要总结
The Purpose of this study is to assess the safety and efficacy of Cannabidiol on treatment of Carpal Tunnel Syndrome.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
- •Subjects taking prescription or non-prescription medication which are substrates of CYP3A4 (Itraconazole, Ketoconazole, Azamulin, Troleandomycin, Verapamil, John's wart, Phenobarbital), CYP2C19 (Nootkatone, Ticlopidine, Rifampin, Omeprazole), CYP2C8 (Montelukast, Quercetin, Phenelzine, Rifampin, Clopidogrel) , CYP2C9 (Sulfaphenazole, Tienilic acid, Carbamazepine, Apalutamide, Fluconazole, Celecoxib), CYP1A2 (alpha-Naphthoflavone, Furafylline, Phenytoin, Rifampin, Ritonavir, smoking, Teriflunomide, Ciproflaoxacin, oral contraceptives, Alloprinol) and CYP2B6 (Sertraline, Phencyclidine, Thiotepa, Ticlopidine, Carbamazepine, Efavirenez, Rifampin, Bupropion) within 14 days of the study procedure.
研究组 & 干预措施
Cannabidiol
Participants will receive 5mL syringe with Cannabidiol (Investigational drug) in it.
干预措施: Cannabidiol (Drug)
结局指标
主要结局
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.
时间窗: 2 weeks and then crossover to other cream for 2 more weeks after a 1 week washout period.
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.
次要结局
- 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)
- Along with efficacy, safety of CBD is measured by performing set of Laboratory tests(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)
- Safety of CBD is measured by collecting relevant Medical History as a part of safety assessment.(2 weeks)
- Safety of CBD is measured by performing skin monitoring tests and physical examination.(2 weeks)
研究者
Brent DeGeorge
Plastic Surgeon and Assistant Professor
University of Virginia