The Effect of Theraworx Foam in Carpal Tunnel Syndrome

NCT ID: NCT04017390

Last Updated: 2022-01-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-01-03

Brief 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.

Detailed 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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1: Theraworx Foam alone

Theraworx foam only

Group Type: EXPERIMENTAL

Theraworx Foam

Intervention Type: DRUG

Apply Theraworx Foam alone

Arm 2: Theraworx Foam and night splint

Theraworx foam with a night time splint

Group Type: ACTIVE_COMPARATOR

Theraworx Foam and night splint

Intervention Type: OTHER

Apply Theraworx Foam and night time splint

Arm 3: Placebo foam alone

Placebo foam alone

Group Type: PLACEBO_COMPARATOR

Placebo Foam

Intervention Type: DRUG

Apply placebo foam alone

Arm 4: Placebo foam and night splint

Placebo foam with a night time splint

Group Type: OTHER

Placebo Foam and night time splint

Intervention Type: OTHER

Apply placebo foam and night time splint

Interventions

Theraworx Foam

Apply Theraworx Foam alone

Intervention Type: DRUG

Placebo Foam

Apply placebo foam alone

Intervention Type: DRUG

Theraworx Foam and night splint

Apply Theraworx Foam and night time splint

Intervention Type: OTHER

Placebo Foam and night time splint

Apply placebo foam and night time splint

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avadim Technologies, Inc.

INDUSTRY

Sponsor Role: collaborator

John Fowler

OTHER

Sponsor Role: lead

Responsible Party

John Fowler

Assistant Professor Department of Orthopaedic Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

John Fowler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Kaufmann Building

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY19040180

Identifier Type: -

Identifier Source: org_study_id