The Effect of Theraworx Foam in Carpal Tunnel Syndrome

NCT04017390 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: STUDY19040180
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Carpal Tunnel Syndrome

Keywords

Hand Pain/Numbness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Improvement (decrease) in Boston Carpal Tunnel Questionnaire (BCTQ)

  2 weeks

• Improvement (decrease) in Carpal Tunnel 6 (CTS-6) score

  2 weeks

• Improvement (decrease) in Disabilities of Arm, Shoulder, Hand (DASH) score

  2 weeks

Study Arms (4)

Arm 1: Theraworx Foam alone

EXPERIMENTAL

Theraworx foam only

Drug: Theraworx Foam

Arm 2: Theraworx Foam and night splint

ACTIVE COMPARATOR

Theraworx foam with a night time splint

Other: Theraworx Foam and night splint

Arm 3: Placebo foam alone

PLACEBO COMPARATOR

Placebo foam alone

Drug: Placebo Foam

Arm 4: Placebo foam and night splint

OTHER

Placebo foam with a night time splint

Other: Placebo Foam and night time splint

Interventions

Theraworx Foam DRUG

Apply Theraworx Foam alone

Arm 1: Theraworx Foam alone

Placebo Foam DRUG

Apply placebo foam alone

Arm 3: Placebo foam alone

Theraworx Foam and night splint OTHER

Apply Theraworx Foam and night time splint

Arm 2: Theraworx Foam and night splint

Placebo Foam and night time splint OTHER

Apply placebo foam and night time splint

Arm 4: Placebo foam and night splint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Carpal Tunnel Syndrome
• Age 18 years or older
• Interest in non-surgical treatment of carpal tunnel syndrome

You may not qualify if:

• 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)

Sponsors & Collaborators

• John Fowler: lead
• Avadim Technologies, Inc.: collaborator

Study Sites (2)

Kaufmann Building

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• John Fowler, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor Department of Orthopaedic Surgery

Model Details: 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. 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.

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 12, 2019
• Study Start: January 1, 2022
• Primary Completion: January 3, 2022
• Study Completion: January 3, 2022
• Last Updated: January 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• 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.

Locations

US (2)