N-acetylcysteine and night splinting for treating carpal tunnel syndrome
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
This study is testing if taking N-acetylcysteine along with wearing a night splint can help people with mild to moderate carpal tunnel syndrome feel better without needing surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nova Scotia Health Authority Academic / other |
| Locations | 1 site (Halifax, Nova Scotia) |
| Trial ID | NCT04460521 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of N-acetylcysteine (NAC) combined with night splinting as a non-operative treatment for mild to moderate carpal tunnel syndrome (CTS). Participants will undergo an 8-week trial of wrist splinting while also receiving oral NAC to assess any improvements in symptoms such as pain, numbness, and functional impairment. The study aims to provide a safer alternative to surgical interventions for patients who do not respond to traditional conservative treatments. The trial will include patients with confirmed diagnoses of CTS based on clinical and electrodiagnostic criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of mild to moderate idiopathic unilateral or bilateral carpal tunnel syndrome.
Not a fit: Patients with severe carpal tunnel syndrome or those who have undergone previous surgical interventions on the affected limb may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a non-invasive treatment option that alleviates symptoms of carpal tunnel syndrome and reduces the need for surgery.
How similar studies have performed: While there is a growing body of research on non-operative treatments for CTS, the specific combination of NAC and night splinting has not been extensively tested, making this a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The patient has a confirmed diagnosis of mild to moderate idiopathic unilateral or bilateral CTS as determined by both clinical exam findings and electrodiagnostic nerve conduction studies (median nerve distal motor latency ≥ 4.3 milliseconds and/or median nerve sensory distal latency ≥ 3.5 milliseconds at the wrist) performed within the preceding year prior to enrollment 2. Symptoms of CTS must have been present for ≥ 6 weeks 3. The patient must be ≥ 18 years of age. Exclusion Criteria: 1. Any previous carpal tunnel release procedure on the ipsilateral limb 2. Any previous corticosteroid injection in the last 6 months on the ipsilateral limb 3. Severe CTS/signs of median nerve denervation with axonal loss determined by constant wrist or hand pain, constant parasthesias in the median nerve distribution, or thenar muscle atrophy in the ipsilateral limb 4. Any known or suspected allergy to NAC 5. Any current medications which preclude use of NAC including antibiotics or nitroglycerin 6. Breastfeeding patients or patients with nephrolithiasis 7. Any history of proximal ipsilateral neck or proximal limb injury 8. Secondary CTS related to pregnancy 9. Unable for financial reasons to obtain a night splint (i.e. lack of insurance coverage or lack of financial means).
Where this trial is running
Halifax, Nova Scotia
- Queen Elizabeth II Health Sciences Center, Halifax Infirmary Site — Halifax, Nova Scotia, Canada (Recruiting)
Study contacts
- Study coordinator: Emily M Krauss, MD
- Email: emilymkrauss@gmail.com
- Phone: 902-473-7887
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.