Theraworx Foam for Carpal Tunnel Syndrome

No longer recruiting at 1 trial location

Overseen By Karen Wasil, BSN

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: John Fowler

Must not be taking: Topical anti-inflammatories

Disqualifiers: Prior carpal tunnel release, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a foam treatment called Theraworx for individuals with carpal tunnel syndrome, a condition causing pain and numbness in the hand. Participants will join one of four groups: using Theraworx foam alone, Theraworx foam with a night splint, a placebo foam, or a placebo foam with a night splint. The trial aims to determine if the foam reduces symptoms and whether the splint adds any benefit. Ideal candidates for this trial are those diagnosed with carpal tunnel syndrome seeking non-surgical treatment options. Participants will attend three study visits over approximately three weeks. As a Phase 4 trial, this research helps to understand how the already FDA-approved Theraworx benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using topical anti-inflammatory medication.

What is the safety track record for these treatments?

Research has shown that Theraworx Foam is generally safe to use. It meets safety standards and poses no danger. The foam's ingredients are non-toxic and safe for daily use. Users have found it helpful for muscle cramps and spasms without major issues. It works on the applied area and does not affect the rest of the body.

Although the foam is safe, avoid contact with eyes and do not ingest it. If irritation occurs, discontinue use and consult a doctor. As this treatment is in a late-phase trial, strong evidence supports its safety for people. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike typical treatments for carpal tunnel syndrome, which often involve oral medications, steroid injections, or surgery, Theraworx Foam offers a topical alternative that could provide relief without the need for invasive procedures. Researchers are excited about Theraworx Foam because it is designed to be applied directly to the skin, potentially reducing inflammation and discomfort with fewer side effects. Additionally, when combined with a night splint, it may provide enhanced support and symptom relief during sleep, which is a common time for carpal tunnel symptoms to worsen. This approach could offer a more convenient and accessible option for many patients.

What evidence suggests that this trial's treatments could be effective for wrist symptoms?

Research has shown that Theraworx Foam, which participants in this trial may receive, might help reduce muscle cramps and spasms. In studies, about 60% of people noticed improvements in these symptoms. This trial will also evaluate night splints, which have been shown to help with carpal tunnel syndrome in the short term by keeping the wrist straight and relieving pressure on the median nerve. While Theraworx Foam is already used for muscle cramps, its ability to reduce swelling and pain makes it a promising option for carpal tunnel syndrome. Participants in this trial may receive Theraworx Foam alone, in combination with a night splint, or placebo treatments. ^{6 7 8 9 10}

Who Is on the Research Team?

John Fowler, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

Inclusion Criteria

Diagnosis of Carpal Tunnel Syndrome

Interest in non-surgical treatment of carpal tunnel syndrome

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive Theraworx foam or placebo, with or without a night splint, for carpal tunnel syndrome

2 weeks

3 visits (in-person, 1 week apart)

Follow-up

Participants are monitored for changes in symptoms and median nerve size using questionnaires and ultrasound

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Placebo Foam
• Placebo Foam and night time splint
• Theraworx Foam
• Theraworx Foam and night splint

How Is the Trial Designed?

Group I: Arm 4: Placebo foam and night splint Experimental Treatment 1 Intervention

Placebo foam with a night time splint

Group II: Arm 1: Theraworx Foam alone Experimental Treatment 1 Intervention

Theraworx foam only

Group III: Arm 2: Theraworx Foam and night splint Active Control 1 Intervention

Theraworx foam with a night time splint

Group IV: Arm 3: Placebo foam alone Placebo Group 1 Intervention

Placebo foam alone

Who Is Running the Clinical Trial?

John Fowler

Lead Sponsor

Trials

3

Recruited

80+

Avadim Technologies, Inc.

Industry Sponsor

Trials

4

Recruited

1,600+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03159260

Effect of Theraworx/[pH]Uel on Night-time Leg Cramps and ...

The purpose of this study is to determine the effect of Theraworx/[pH]uel on the frequency and severity of night-time cramps and spasms symptoms, ...

2.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/60/NCT03159260/Prot_SAP_001.pdf

The Effect of Theraworx/[pH]uel on night-time cramps and ...

During this final visit subjects again completed the same measures of sleep quality, quality of life and depression that they completed during their Baseline ...

3.

theraworxpro.com

theraworxpro.com/clinical-studies/

Clinical Studies

A pilot to evaluate a silver based bathing product to reduce central line-associated bloodstream infections.

4.

health.harvard.edu

health.harvard.edu/blog/harvard-health-ad-watch-aches-pains-and-muscle-cramps-do-well-advertised-remedies-actually-work-202105192456

Harvard Health Ad Watch: Aches, pains, and muscle cramps

Theraworks Relief for Muscle Cramps and Spasms: Two studies mentioned in an ad show improvement in muscle cramps and spasms in 60% of 84 ...

5.

trials.arthritis.org

trials.arthritis.org/trials/NCT03770091

Impact of TheraWorx Foam on Symptom Relief in Thumb Arthritis

Novel treatment of inflammation can potentially reduce inflammation and pain associated with progressing osteoarthritis. Theraworx Relief is an FDA registered ...

6.

imgcdn.mckesson.com

imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_AVADIM_BATHING_SYSTEM_THERAWORX_ADVHYGIENE_BARRIER_SYS_8_PK_30PK.pdf

SAFETY DATA SHEET

This chemical is not considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200). Page 2. Theraworx Fragrance Free ...

7.

punchout.medline.com

punchout.medline.com/media/catalog/Docs/MSDS/MSD_SDSD721962.pdf

SAFETY DATA SHEET

Do not scatter spilled material with high pressure water streams. Specific hazards arising from the chemical. No information available.

8.

theraworx.com

theraworx.com/product/muscle-cramps-foam/

Muscle Cramp Relief Foam

... Safe to use daily. Ingredients. Magnesium Sulfate (Magnesia sulphurica) 6X 0.05% HPUS, Aqua (Water), Cocamidopropyl Betaine, Aloe Barbadensis Leaf Juice ...

9.

shop.nysid.org

shop.nysid.org/mpattachments/file/download/id/141/product_id/39817/

SAFETY DATA SHEET

Serious eye damage/eye irritation No information available. Page 7. 1593187 - Theraworx Protect Advanced Hygiene for. Hand and T-Zone defense.

10.

theraworxpro.com

theraworxpro.com/safety/

Safety

The primary safety benefit of the Theraworx range of products is to the patient. The reference documents include results of cytotoxicity, irritant and ...