The Effect of Theraworx Foam in Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04017390
• Other study ID #: STUDY19040180
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 1, 2022
• Est. completion date: January 3, 2022

Study information

• Verified date: January 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 3, 2022
• Est. primary completion date: January 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Drug:
• Theraworx Foam
Apply Theraworx Foam alone
• Placebo Foam
Apply placebo foam alone

Other:
• Theraworx Foam and night splint
Apply Theraworx Foam and night time splint
• Placebo Foam and night time splint
Apply placebo foam and night time splint

Locations

Country	Name	City	State
United States	Kaufmann Building	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
John Fowler	Avadim Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement (decrease) in size of median nerve at the wrist	Decrease in cross sectional area of median nerve as determined by ultrasound exam	2 weeks
Secondary	Improvement (decrease) in Boston Carpal Tunnel Questionnaire (BCTQ)	Improvement in PRO as indicated by a decreased score on questionnaire indicating improved in function and decreased symptoms	2 weeks
Secondary	Improvement (decrease) in Carpal Tunnel 6 (CTS-6) score	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)	2 weeks
Secondary	Improvement (decrease) in Disabilities of Arm, Shoulder, Hand (DASH) score	Improvement in patient reported outcome (PRO) as determined by decreased DASH score from baseline. Score ranges from 150 (worst) to 30 (best)	2 weeks