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.

Study Overview

• Status: Withdrawn
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Drug: Theraworx Foam; Other: Theraworx Foam and night splint; Drug: Placebo Foam; Other: Placebo Foam and night time splint

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • Kaufmann Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Theraworx Foam alone; Theraworx foam only	Drug: Theraworx Foam; Apply Theraworx Foam alone
Active Comparator: Arm 2: Theraworx Foam and night splint; Theraworx foam with a night time splint	Other: Theraworx Foam and night splint; Apply Theraworx Foam and night time splint
Placebo Comparator: Arm 3: Placebo foam alone; Placebo foam alone	Drug: Placebo Foam; Apply placebo foam alone
Other: Arm 4: Placebo foam and night splint; Placebo foam with a night time splint	Other: Placebo Foam and night time splint; Apply placebo foam and night time splint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: John Fowler
• Collaborators: Avadim Technologies, Inc.
• Investigators: Principal Investigator: John Fowler, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Actual): January 3, 2022
• Study Completion (Actual): January 3, 2022

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Hand Pain/Numbness
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: STUDY19040180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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
• IPD Sharing Time Frame: 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.
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No