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The ACTS Trial: N-acetylcysteine (NAC) and Night-splinting as a Non-operative Treatment for Carpal Tunnel Syndrome
Sponsor: Emily Krauss
Summary
Carpal tunnel syndrome (CTS) is the most common nerve compression syndrome worldwide, causing significant chronic pain, functional impairment, and lowered quality of life for individuals of various backgrounds. CTS is caused by chronic compression of the median nerve in the carpal tunnel of the wrist, causing numbness and pain in the palm, thumb, index, and middle fingers and eventual weakness of the hand. Many different treatments for CTS have been proposed and studied, including but not limited to non-operative treatments such as wrist splinting, steroid injections, and lifestyle modifications as well as operative treatments, such as surgical carpal tunnel release (CTR). To date, very few oral medications have been shown to be effective as conservative treatments for CTS. In this study the investigators will examine whether there is any benefit to using oral N-acetylcysteine (NAC) as an adjunctive treatment for mild to moderate CTS in addition to a standard 8-week trial of night splinting. NAC has been used in humans for various purposes, is extremely safe and has very few side effects, and has been shown to have anti-inflammation properties which may help treat CTS. The investigators will study this by performing a randomized controlled trial, comparing patients receiving oral NAC and standard night splinting to patients receiving an identical placebo and standard night splinting. Both patient groups will be assessed using a questionnaire to assess for severity of their CTS symptoms both before and after the 8-week treatment. The primary objective will be to determine whether supplementation with oral NAC in addition to night splinting has any significant impact on patient-reported symptoms and functional impairment when compared to night splinting alone. The investigators will also measure secondary outcomes including whether patients decide to have surgery for their CTS after treatment and/or continued use of other treatments. This study has the potential to have a significant positive impact on patients by identifying a safe, inexpensive, accessible, and well tolerated conservative treatment for mild to moderate carpal tunnel syndrome, and potentially preventing the need for additional, more invasive treatments such as surgery.
Official title: The Use of N-acetylcysteine Supplementation in Addition to Night Splinting for Treatment of Mild to Moderate Carpal Tunnel Syndrome: A Randomized, Double-blind, Placebo-controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2022-04-01
Completion Date
2026-10-01
Last Updated
2024-08-23
Healthy Volunteers
Yes
Conditions
Interventions
N-Acetyl cysteine
In addition to splinting, both groups will receive an oral tablet to take daily for 8 weeks. Participants assigned to the experimental group will receive oral NAC (500 mg PO daily for eight weeks; based on recommended daily dose for use as an antioxidant and dosing in previous human clinical trials and animal studies), and those assigned to the control group will be given a similar looking placebo with identical instructions. Tablets will be provided in a blister pack to assist with compliance.
Wrist Splint
Participants in both arms will be given a standard prescription for a prefabricated night splint which keeps the wrist in a neutral position and instructed on proper use and the importance of consistent use. To limit splint variability, we will ensure that splint prescriptions are written such that a MedSpec Wrist Lacer II splint is obtained from the patient's pharmacy. This is the most commonly available brand locally and meets the criteria for wrist, metacarpophalangeal, and interphalangeal joint positioning. They will be advised to wear the splint consistently during sleeping hours on their affected wrist for eight weeks, as is the standard of practice.
Locations (1)
Queen Elizabeth II Health Sciences Center, Halifax Infirmary Site
Halifax, Nova Scotia, Canada