#Foam core tunnel pro
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. Individual Participant Data (IPD) Sharing Statement: John Fowler, Assistant Professor Department of Orthopaedic Surgery, University of Pittsburgh The Effect of Theraworx Foam on the Cross-sectional Area of the Median Nerve in Patients With Carpal Tunnel Syndrome 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. 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. Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information 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.
#Foam core tunnel how to
Instructions on how to apply the foam, whether or not and how to wear the splint, and return visits will be provided. The active ingredient in Theraworx foam is magnesium sulfate and will not be in the placebo foam. 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. Scores can range from 0 to 150 and the higher the score the worse the symptoms/disability. The DASH is a 30 item tool with each scored 1 to 5.Scores range from 0 to 26 with a higher score reflecting increased severity. The CTS-6 is a six item tool that combines reported symptoms with a physical exam of the hand.Score range is from 0 to 95 with a high number indicating more severe/worsening symptoms and lower number less severe/improving symptoms. The Boston Carpal Tunnel is a 19 question tool that assesses function (8 items) and symptom severity (11 items).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). 2.) Carpal Tunnel-6 (CTS-6) and 3.) Disabilities of the Arm, Shoulder and Hand (DASH). The questionnaires are 1.) Boston Carpal Tunnel (BCT). These will document baseline/change in the size of the median nerve and improvement in function/symptoms. Evaluation of symptoms will be by exam, questionnaires, and ultrasound of the median nerve. The PI will identify potential participants from his clinical practice. Why Should I Register and Submit Results?.
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