A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome.
D W Levine, B P Simmons, M J Koris...
https://pubmed.ncbi.nlm.nih.gov/8245050/Actively Recruiting
Led by Emily Krauss · Updated on 2024-08-23
240
Participants Needed
1
Research Sites
26 weeks
Total Duration
Carpal tunnel syndrome CTS is a common nerve compression condition that causes pain, numbness, and weakness in the hand, affecting many people worldwide. This trial evaluates whether adding oral N-acetylcysteine NAC, a safe antioxidant supplement, to a standard 8-week night splinting treatment can improve symptoms and hand function in people with mild to moderate CTS. The study is a randomized, double-blind, placebo-controlled trial comparing NAC plus splinting to placebo plus splinting. Participants will take either a 500 mg oral NAC tablet or a matching placebo daily while wearing a wrist splint at night for 8 consecutive weeks. Both groups will follow the same splinting and tablet regimen. The study includes an initial treatment period followed by assessments at 8 weeks and a further follow-up at 6 months for those who do not choose surgery after the initial treatment. During the study, participants will complete the Boston Carpal Tunnel Questionnaire BCTQ before treatment, at 8 weeks, and again at 6 months if surgery is deferred. Researchers will monitor symptom severity, hand function, and whether participants decide to undergo carpal tunnel release surgery. Safety, adherence, and side effects will be tracked throughout. The total participation may last up to 6 months including follow-up evaluations.
CONDITIONS
The ACTS Trial: N-acetylcysteine (NAC) and Night-splinting as a Non-operative Treatment for Carpal Tunnel Syndrome
E
Emily M Krauss, MD
A
Anna Duncan, MD
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Emily Krauss
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 8 weeks
Participants take either an oral N-acetylcysteine (NAC) tablet or a placebo daily while wearing a standard wrist splint nightly for 8 weeks to treat mild to moderate carpal tunnel syndrome.
1 baseline visit and 1 follow-up visit at 8 weeks (in-person)
Duration - Up to 6 months after treatment
Participants who do not proceed with surgery after treatment are followed up at 6 months to assess continued symptoms, treatment use, and any decision to have surgery.
1 follow-up visit at 6 months (in-person or remote)
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor