Posture Correction Device for Cubital Tunnel Syndrome

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

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Spinal surgery, Carpal tunnel, T2DM, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

40 Participants Needed

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. ^{1 2 3 4 5}

Research Team

Elspeth Hill, MBChB, PhD, MRes, MRCS

Principal Investigator

Yale University

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 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.

I can wear a posture trainer daily and use its app and questionnaire.

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.

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

Treatment Details

Interventions

• UpRight Go

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Findings from Research

Cubital tunnel syndrome (CTS) is a common condition caused by ulnar nerve compression, leading to symptoms like numbness, tingling, and potential muscle weakness in the hand.

Treatment options for CTS include both nonsurgical methods and various surgical procedures, but the effectiveness and indications for each approach remain debated, highlighting the need for further research to establish a standardized treatment protocol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Progress of treatment of cubital tunnel syndrome]. Yu, S., Liu, S., Fan, C.[2018]

In a study of 12 patients with acute exacerbation of cubital tunnel syndrome, it was found that cysts compressing the ulnar nerve were a significant cause of their symptoms, highlighting the importance of identifying this issue.

Surgical intervention, which included nerve decompression and cyst resection, successfully relieved symptoms in all patients, with follow-up results showing 2 'Excellent', 8 'Good', and 2 'Acceptable' outcomes, indicating effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Characteristic and treatment of acute aggravating cubital tunnel syndrome]. Chen, R., Kan, S., Li, J.[2018]

In a study of 19 patients with mild to moderate cubital tunnel syndrome, 88% of treated extremities improved without the need for surgery after a 3-month regimen of rigid night splinting and activity modifications.

Significant improvements were observed in patient-reported outcomes, including a reduction in disability scores and increased grip strength, indicating that this treatment is both effective and well-tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of rigid night splinting and activity modification in the treatment of cubital tunnel syndrome. Shah, CM., Calfee, RP., Gelberman, RH., et al.[2021]

Ulnar nerve strain significantly increases during elbow flexion, with measurements showing that both normal and cubitus valgus deformities resulted in similar strain levels, indicating that these deformities do not exacerbate strain at the nerve.

In contrast, cubitus varus deformities led to a relaxation of the ulnar nerve during elbow extension, but this effect diminished with elbow flexion, suggesting that the type of elbow deformity can influence nerve strain differently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cadaveric study of ulnar nerve strain at the elbow associated with cubitus valgus/varus deformity. Nagashima, M., Omokawa, S., Nakanishi, Y., et al.[2022]

In a case series of 7 patients with mild to moderate cubital tunnel syndrome (CTS), conservative treatment including nerve mobilization techniques led to significant improvements in pain levels, grip strength, and overall functional status over an 8-week rehabilitation program and at a 12-month follow-up.

The use of neurodynamic mobilizations, which enhance ulnar nerve gliding, was effective in reducing symptoms and improving patient outcomes, suggesting that this approach can be beneficial for managing CTS in selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurodynamic mobilization in the conservative treatment of cubital tunnel syndrome: long-term follow-up of 7 cases. Oskay, D., Meriç, A., Kirdi, N., et al.[2022]

References

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

[Progress of treatment of cubital tunnel syndrome]. [2018]

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

[Characteristic and treatment of acute aggravating cubital tunnel syndrome]. [2018]

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

Outcomes of rigid night splinting and activity modification in the treatment of cubital tunnel syndrome. [2021]

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

A cadaveric study of ulnar nerve strain at the elbow associated with cubitus valgus/varus deformity. [2022]

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]