The Effect of Theraworx Foam in Carpal Tunnel Syndrome

John Fowler

Status and phase: Withdrawn; Phase 4

Conditions: Carpal Tunnel Syndrome

Treatments: Other: Theraworx Foam and night splint; Other: Placebo Foam and night time splint; Drug: Placebo Foam; Drug: Theraworx Foam

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04017390

STUDY19040180

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 4 patient groups, including a placebo group

Arm 1: Theraworx Foam alone

Experimental group

Description:

Theraworx foam only

Treatment:

Drug: Theraworx Foam

Arm 2: Theraworx Foam and night splint

Active Comparator group

Description:

Theraworx foam with a night time splint

Treatment:

Other: Theraworx Foam and night splint

Arm 3: Placebo foam alone

Placebo Comparator group

Description:

Placebo foam alone

Treatment:

Drug: Placebo Foam

Arm 4: Placebo foam and night splint

Other group

Description:

Placebo foam with a night time splint

Treatment:

Other: Placebo Foam and night time splint