Actively Recruiting

Phase 4
Age: 18Years +
All Genders
Healthy Volunteers
ID04460521

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

Led by Emily Krauss · Updated on 2024-08-23

240

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of mild to moderate idiopathic unilateral or bilateral carpal tunnel syndrome based on clinical exam and nerve conduction studies within the past year
  • Symptoms must have been present for 6 weeks or more
  • Patient must be 18 years of age or older
Not Eligible

You will not qualify if you...

  • Previous carpal tunnel release surgery on the same limb
  • Corticosteroid injection in the affected limb within the last 6 months
  • Severe carpal tunnel syndrome with constant pain, constant numbness, or muscle wasting in the hand
  • Known or suspected allergy to N-acetylcysteine (NAC)
  • Current use of medications that prevent NAC use, including certain antibiotics or nitroglycerin
  • Breastfeeding patients or patients with kidney stones
  • History of injury to the neck or limb on the affected side
  • Carpal tunnel syndrome related to pregnancy
  • Unable to afford night splint due to financial reasons such as lack of insurance coverage

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

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)

Follow-up

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)

Trial Site Locations

Total: 1 location

1

Queen Elizabeth II Health Sciences Center, Halifax Infirmary Site

Halifax, Nova Scotia, Canada, B3H3A6

Actively Recruiting

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Research Team

E

Emily M Krauss, MD

A

Anna Duncan, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial.

Linda S Chesterton, Milica Blagojevic-Bucknall, Claire Burton...

https://pubmed.ncbi.nlm.nih.gov/30343858

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

Carpal tunnel syndrome: hand surgeons, hand therapists, and physical medicine and rehabilitation physicians agree on a multidisciplinary treatment guideline—results from the European HANDGUIDE Study.

Bionka M Huisstede, Jan Fridén, J Henk Coert...

https://pubmed.ncbi.nlm.nih.gov/25127999