Status:
RECRUITING
The ACTS Trial: N-acetylcysteine (NAC) and Night-splinting as a Non-operative Treatment for Carpal Tunnel Syndrome
Lead Sponsor:
Emily Krauss
Conditions:
Carpal Tunnel Syndrome
Hand Injuries and Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ba...
Detailed Description
Introduction: Carpal tunnel syndrome (CTS) is the most prevalent and widely studied peripheral nerve entrapment syndrome, with estimates between 10-20% of the general population having clinical sympto...
Eligibility Criteria
Inclusion
- 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
- Symptoms of CTS must have been present for ≥ 6 weeks
- The patient must be ≥ 18 years of age.
Exclusion
- Any previous carpal tunnel release procedure on the ipsilateral limb
- Any previous corticosteroid injection in the last 6 months on the ipsilateral limb
- 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
- Any known or suspected allergy to NAC
- Any current medications which preclude use of NAC including antibiotics or nitroglycerin
- Breastfeeding patients or patients with nephrolithiasis
- Any history of proximal ipsilateral neck or proximal limb injury
- Secondary CTS related to pregnancy
- Unable for financial reasons to obtain a night splint (i.e. lack of insurance coverage or lack of financial means).
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04460521
Start Date
April 1 2022
End Date
October 1 2026
Last Update
August 23 2024
Active Locations (1)
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1
Queen Elizabeth II Health Sciences Center, Halifax Infirmary Site
Halifax, Nova Scotia, Canada, B3H3A6