The Effect of Theraworx Foam in Carpal Tunnel Syndrome

  • STATUS
    Recruiting
  • End date
    Oct 18, 2022
  • participants needed
    60
  • sponsor
    John Fowler
Updated on 18 February 2021
non-surgical treatment

Summary

Participation will be for approximately 21 days (3 study visits,1 week apart with allowance for scheduling conflicts). A topical (or placebo) foam alone or with a splint will be used. Demographic and symptom information will be obtained. At each visit 3 questionnaires (BCT, CTS-6, and DASH) will be completed and an ultrasound of the wrist (median nerve) will be done to document any change in symptoms and/or in the size of the nerve. Random assignment will be to one of 4 groups: foam or placebo with or without a night splint. We will provide instruction on how to apply the foam, whether or not and how to wear the splint, and return visits.

Description

The PI will identify potential participants from his clinical practice. Evaluation of symptoms will be by exam, questionnaires, and ultrasound of the median nerve. These will document baseline/change in the size of the median nerve and improvement in function/symptoms. The questionnaires are 1.) Boston Carpal Tunnel (BCT). 2.) Carpal Tunnel-6 (CTS-6); and 3.) Disabilities of the Arm, Shoulder and Hand (DASH). These will be used to document a baseline and change (if any) in nerve size and hand symptoms, over a 2 week time frame, that are common in carpal tunnel syndrome (including numbness, pain, tingling, and/or decreased function).

  1. The Boston Carpal Tunnel is a 19 question tool that assesses function (8 items) and symptom severity (11 items). Score range is from 0 to 95 with a high number indicating more severe/worsening symptoms and lower number less severe/improving symptoms.
  2. The CTS-6 is a six item tool that combines reported symptoms with a physical exam of the hand. Scores range from 0 to 26 with a higher score reflecting increased severity.
  3. The DASH is a 30 item tool with each scored 1 to 5. Scores can range from 0 to 150 and the higher the score the worse the symptoms/disability.

Treatment groups are as follows:1.) Theraworx foam alone; 2.) Theraworx foam with night time splint; 3.) Placebo foam alone; 4.) Placebo foam with night time splint. The active ingredient in Theraworx foam is magnesium sulfate and will not be in the placebo foam. Instructions on how to apply the foam, whether or not and how to wear the splint, and return visits will be provided. If in a group that requires night time splinting, the subject must wear the splint only at night and for a minimum of 8 hours.

Details
Condition Carpal Tunnel Syndrome
Treatment Theraworx Foam, Placebo Foam, Theraworx Foam and night splint, Placebo Foam and night time splint
Clinical Study IdentifierNCT04017390
SponsorJohn Fowler
Last Modified on18 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of Carpal Tunnel Syndrome
Age 18 years or older
Interest in non-surgical treatment of carpal tunnel syndrome

Exclusion Criteria

Prior carpal tunnel release
Non-English speaking
Skin lesions/rashes on hand being treated
Current use of topical anti-inflammatory medication
Other diagnoses that would impact results (determined by PI)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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