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The Effect of Theraworx Foam in Carpal Tunnel Syndrome

NCT04017390 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2022-01-21

No results posted yet for this study

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

Interventions

DRUG

Theraworx Foam

Apply Theraworx Foam alone

DRUG

Placebo Foam

Apply placebo foam alone

OTHER

Theraworx Foam and night splint

Apply Theraworx Foam and night time splint

OTHER

Placebo Foam and night time splint

Apply placebo foam and night time splint

Sponsors & Collaborators

  • Avadim Technologies, Inc.

    collaborator INDUSTRY

  • John Fowler

    lead OTHER

Principal Investigators

  • John Fowler, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2022-01-03
Completion
2022-01-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04017390 on ClinicalTrials.gov