Posture Correction Device for Cubital Tunnel Syndrome

Recruiting in Palo Alto (17 mi)

Overseen by Elspeth Hill, MBChB, PhD, MRes, MRCS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Yale University

Disqualifiers: Spinal surgery, Carpal tunnel, T2DM, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to determine whether the UpRight Go posture trainer reduces the symptoms of cubital tunnel syndrome in patients who have not had corrective surgery, as determined by improvements in VAS scores for pain, numbness, and weakness.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the UpRight Go treatment different from other treatments for cubital tunnel syndrome?

The UpRight Go treatment is unique because it focuses on posture correction, which is not a standard approach for cubital tunnel syndrome. Traditional treatments often involve splinting or nerve mobilization, but UpRight Go aims to improve posture to reduce strain on the ulnar nerve at the elbow.

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Eligibility Criteria

This trial is for adults aged 18-99 with symptoms of cubital tunnel syndrome, such as pain or numbness in the arm and weak grip. Participants must be able to wear a posture trainer device daily and use an app. Those with past hand surgeries, spinal surgery, pregnancy, silicone allergies, or certain chronic conditions like diabetes cannot join.

Inclusion Criteria

I am between 18 and 99 years old.

I am willing and able to follow all study rules and attend all appointments.

I experience pain, numbness, or weakness in my hand and fingers, suggesting cubital tunnel syndrome.

Exclusion Criteria

Pregnancy or lactation

I have had surgery for cubital tunnel syndrome or have carpal tunnel syndrome.

You have had allergic reactions to silicon.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard of care treatment alone or standard of care with posture training using the UpRight Go posture trainer for 6 weeks

6 weeks

1 visit (in-person) at baseline, 1 visit (in-person) at 6 weeks

Follow-up

Participants are monitored for symptom improvement or resolution after treatment

4 weeks

Participant Groups

The study tests if the UpRight Go posture trainer can reduce symptoms of cubital tunnel syndrome in patients who haven't had surgery for it. Success is measured by improvements in pain, numbness, and weakness using VAS scores.

Group I: normal conservative management + posture training Experimental Treatment 1 Intervention

Participants will receive normal conservative management as well as posture training via the UpRight Go posture trainer. The device will be provided to participants with all supplies and instructions that come from the original manufacturer and will be walked through how to install and use the necessary smartphone application as well as wear the posture trainer. Participants will be asked to wear the device daily for six weeks with goals for the amount of time spent wearing the sensor each day provided by the smartphone app. Participants will return to clinic in six weeks to return the device and submit usage data, or will mail back the device. Devices will be cleaned with disinfectant wipes before use by future participants.

Group II: normal conservative management only (standard of care) Active Control 1 Intervention

Participants will receive conservative management.only: standard of care for initial treatment of cubital tunnel syndrome

UpRight Go is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as UpRight Go for:

• Posture correction
• Cubital tunnel syndrome symptom management

🇺🇸 Approved in United States as UpRight Go for:

• Posture correction
• Cubital tunnel syndrome symptom management

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Yale New Haven Hospital New Haven, CT

Who Is Running the Clinical Trial?

Yale University Lead Sponsor

References

1. China pubmed.ncbi.nlm.nih.gov

[Progress of treatment of cubital tunnel syndrome]. [2018] To review the current progress of treatment of cubital tunnel syndrome (CTS).

2. China pubmed.ncbi.nlm.nih.gov

[Characteristic and treatment of acute aggravating cubital tunnel syndrome]. [2018] To investigate the causes and the characteristics of acute aggravating cubital tunnel syndrome.

3. United States pubmed.ncbi.nlm.nih.gov

Outcomes of rigid night splinting and activity modification in the treatment of cubital tunnel syndrome. [2021] To prospectively analyze, using validated outcome measures, symptom improvement in patients with mild to moderate cubital tunnel syndrome treated with rigid night splinting and activity modifications.

4. England pubmed.ncbi.nlm.nih.gov

A cadaveric study of ulnar nerve strain at the elbow associated with cubitus valgus/varus deformity. [2022] Cubital tunnel syndrome can be caused by overtraction and dynamic compression in elbow deformities. The extent to which elbow deformities contribute to ulnar nerve strain is unknown. Here, we investigated ulnar nerve strain caused by cubitus valgus/varus deformity using fresh-frozen cadavers.

5. United States pubmed.ncbi.nlm.nih.gov

Neurodynamic mobilization in the conservative treatment of cubital tunnel syndrome: long-term follow-up of 7 cases. [2022] The aim of this case series is to describe the effect of nerve mobilization techniques in the standard conservative management of cubital tunnel syndrome (CTS).