The Effect of Theraworx Foam in Carpal Tunnel Syndrome
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Carpal Tunnel Syndrome
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomization will be to one of four groups: 1.) Theraworx foam alone; 2.) Theraworx foam plus night time splint; 3.) Placebo foam alone; 4.) Placebo foam plus night time splint. Theraworx Foam is an FDA registered (NDC 61594-001-02) topical agent (active ingredient: magnesium sulfate superficia 6 x 0.05% HPUS) for muscle cramp and spasm relief.Masking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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.) Bos...
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). 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. 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. 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.
Tracking Information
- NCT #
- NCT04017390
- Collaborators
- Avadim Technologies, Inc.
- Investigators
- Principal Investigator: John Fowler, MD University of Pittsburgh
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