The Effect of Theraworx Foam in Carpal Tunnel Syndrome

The Effect of Theraworx Foam on the Cross-sectional Area of the Median Nerve in Patients With Carpal Tunnel Syndrome

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.

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.

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.

Improvement in PRO as indicated by a decreased score on questionnaire indicating improved in function and decreased symptoms

Improvement in patient reported outcome (PRO) as determined by a lower CTS-6 score number than at baseline. Score ranges from 26 (worst) to 0 (best)

Improvement in patient reported outcome (PRO) as determined by decreased DASH score from baseline. Score ranges from 150 (worst) to 30 (best)

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)

The ultrasound measurements and PRO questionnaire scores will be shared with the sponsor Avadim Technologies at a minimum of approximately 60 day intervals throughout the study (1 year) and at the discretion of the PI. In addition, final data will be provided within 12 months of completion of last participant

Updated at intervals of approximately 60 days (minimum) and as needed as determined by PI. Final data will be available approximately 12 months after completion of last participant and will be available for 9 to 12 months.