Actively Recruiting

Phase 4
Age: 18Years +
All Genders
Healthy Volunteers
NCT04460521

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

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

240

Participants Needed

1

Research Sites

234 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 backgrounds. CTS is caused by chronic compression of the median nerve in the carpal tunnel of the wrist, causing numbness and pain in the palm, thumb, index, and middle fingers and eventual weakness of the hand. Many different treatments for CTS have been proposed and studied, including but not limited to non-operative treatments such as wrist splinting, steroid injections, and lifestyle modifications as well as operative treatments, such as surgical carpal tunnel release (CTR). To date, very few oral medications have been shown to be effective as conservative treatments for CTS. In this study the investigators will examine whether there is any benefit to using oral N-acetylcysteine (NAC) as an adjunctive treatment for mild to moderate CTS in addition to a standard 8-week trial of night splinting. NAC has been used in humans for various purposes, is extremely safe and has very few side effects, and has been shown to have anti-inflammation properties which may help treat CTS. The investigators will study this by performing a randomized controlled trial, comparing patients receiving oral NAC and standard night splinting to patients receiving an identical placebo and standard night splinting. Both patient groups will be assessed using a questionnaire to assess for severity of their CTS symptoms both before and after the 8-week treatment. The primary objective will be to determine whether supplementation with oral NAC in addition to night splinting has any significant impact on patient-reported symptoms and functional impairment when compared to night splinting alone. The investigators will also measure secondary outcomes including whether patients decide to have surgery for their CTS after treatment and/or continued use of other treatments. This study has the potential to have a significant positive impact on patients by identifying a safe, inexpensive, accessible, and well tolerated conservative treatment for mild to moderate carpal tunnel syndrome, and potentially preventing the need for additional, more invasive treatments such as surgery.

CONDITIONS

Official 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 carpal tunnel syndrome by clinical exam and nerve conduction studies within the past year
  • Symptoms of carpal tunnel syndrome present for at least 6 weeks
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Previous carpal tunnel release surgery on the affected 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 affected hand
  • Known or suspected allergy to N-acetylcysteine
  • Current use of medications that prevent NAC use, including antibiotics or nitroglycerin
  • Breastfeeding or having kidney stones
  • History of injury to the neck or limb on the affected side
  • Carpal tunnel syndrome caused by pregnancy
  • Unable to afford a night splint due to financial reasons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

A

Anna Duncan, MD

CONTACT

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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