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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the UpRight Go posture trainer can reduce symptoms of cubital tunnel syndrome, a condition causing pain and numbness in the arm and hand. Participants will be divided into two groups: one receiving standard care and the other receiving both standard care and posture training with the device. The study seeks individuals with symptoms like arm pain or numbness who have not undergone surgery for it. As an unphased trial, this study provides a unique opportunity for participants to explore innovative treatment options that could enhance their quality of life.

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.

What prior data suggests that this posture correction device is safe for cubital tunnel syndrome?

Research shows that the UpRight Go posture trainer is generally easy to use. This small device attaches to the back with skin-friendly adhesives. It improves posture by gently vibrating when the user slouches, serving as a reminder to sit or stand up straight. These features can help strengthen back and core muscles and improve posture in just a few weeks.

No specific reports of problems have emerged from using the UpRight Go. Since it focuses on correcting posture rather than involving medicine or surgery, it usually presents fewer safety concerns. Overall, the UpRight Go appears to be a safe choice for those looking to improve their posture and, in this study, its role in helping with symptoms of cubital tunnel syndrome. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for cubital tunnel syndrome, which often involve rest, splinting, or physical therapy, the UpRight Go posture trainer introduces a new method by focusing on posture correction. This device provides real-time feedback on posture through a smartphone app, encouraging consistent and correct posture throughout the day. Researchers are excited because this approach could offer a non-invasive way to alleviate symptoms by targeting one of the underlying issues—poor posture—potentially reducing reliance on more invasive options like surgery.

What evidence suggests that the UpRight Go posture trainer is effective for cubital tunnel syndrome?

Research shows that the UpRight Go posture trainer can improve posture and reduce pain. One study found that people using the device reported 54% less pain and felt 46% more comfortable while sitting. They also experienced an 86% improvement in overall posture. In this trial, some participants will receive normal conservative management along with posture training using the UpRight Go device. The device helps users maintain good posture, which can be especially beneficial for conditions like cubital tunnel syndrome. By improving posture, it may reduce pressure on the affected nerve, potentially easing symptoms like pain, numbness, and weakness. ^{4 6 7 8 9}

Who Is on the Research Team?

Elspeth Hill, MBChB, PhD, MRes, MRCS

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

Citations

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This study aims to establish whether the use of a wearable posture device can improve the operating time spent in suboptimal, high-risk postures.

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46% Improved sitting discomfort · 54% Pain reduction · 86% Posture improvement.

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The Upright GO 2 is a posture corrector that improves posture in 2 weeks, strengthens back and core muscles, and has training and tracking modes.

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Commercial Postural Devices: A Review - PMC

Upright Go is a wearable posture trainer that is attached to the back via hypoallergenic adhesives which can be reused up to 10 times. The ...