Recruiting PHASE4 Carpal Tunnel Syndrome

New treatment option for Carpal Tunnel Syndrome

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

ClinicalTrials.gov ID: NCT04460521

What this study is testing

What is N-Acetyl cysteine?

N-Acetyl cysteine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for carpal tunnel syndrome.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 4: studies an already-approved treatment
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older. Healthy volunteers may be eligible.

You may be able to join if

  • The patient has a confirmed diagnosis of mild to moderate idiopathic unilateral or bilateral CTS as determined by both clinical exam findings and...
  • Symptoms of CTS must have been present for ≥ 6 weeks
  • The patient must be ≥ 18 years of age.

You likely can't join if

  • 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...
  • 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
See the full eligibility criteria
Who can join
  • 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...
  • Symptoms of CTS must have been present for ≥ 6 weeks
  • The patient must be ≥ 18 years of age.
What rules you out
  • 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).

The study team makes the final eligibility decision.

Where it's taking place

  • Halifax, Nova Scotia, Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Halifax, Nova Scotia, Canada. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.