The ACTS Trial: N-acetylcysteine (NAC) and Night-splinting as a Non-operative Treatment for Carpal Tunnel Syndrome

Phase 4

Recruiting

• Conditions: Carpal Tunnel Syndrome; Hand Injuries and Disorders; Nerve Compression; Splints; Carpal Tunnel; Carpal Tunnel Release

• Registration Number: NCT04460521
• Lead Sponsor: Emily Krauss

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-6-17
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. The patient has a confirmed diagnosis of mild to moderate idiopathic unilateral or<br> bilateral CTS as determined by both clinical exam findings and electrodiagnostic<br> nerve conduction studies (median nerve distal motor latency = 4.3 milliseconds<br> and/or median nerve sensory distal latency = 3.5 milliseconds at the wrist)<br> performed within the preceding year prior to enrollment<br><br> 2. Symptoms of CTS must have been present for = 6 weeks<br><br> 3. The patient must be = 18 years of age.<br><br>Exclusion Criteria:<br><br> 1. Any previous carpal tunnel release procedure on the ipsilateral limb<br><br> 2. Any previous corticosteroid injection in the last 6 months on the ipsilateral limb<br><br> 3. Severe CTS/signs of median nerve denervation with axonal loss determined by constant<br> wrist or hand pain, constant parasthesias in the median nerve distribution, or<br> thenar muscle atrophy in the ipsilateral limb<br><br> 4. Any known or suspected allergy to NAC<br><br> 5. Any current medications which preclude use of NAC including antibiotics or<br> nitroglycerin<br><br> 6. Breastfeeding patients or patients with nephrolithiasis<br><br> 7. Any history of proximal ipsilateral neck or proximal limb injury<br><br> 8. Secondary CTS related to pregnancy<br><br> 9. Unable for financial reasons to obtain a night splint (i.e. lack of insurance<br> coverage or lack of financial means).

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline Boston Carpal Tunnel Questionnaire (BCTQ) at 8 weeks

Secondary Outcome Measures

Name	Time	Method
Number of participants who elect to have surgical carpal tunnel decompression after 8 weeks;Number of participants who elect to have surgical carpal tunnel decompression after 6 months;Change from baseline Boston Carpal Tunnel Questionnaire (BCTQ) at 6 months