← Back to Search

Behavioural Intervention

Posture Correction Device for Cubital Tunnel Syndrome

N/A

Recruiting

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

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Exhibiting signs and symptoms consistent with cubital tunnel syndrome including but not limited to pain, numbness, or paresthesia in an ulnar distribution, loss of grip strength, or loss of fine motor control of the fingers

Be older than 18 years old

Must not have

History of cubital tunnel release surgery or carpal tunnel syndrome

History of spinal surgery, hand surgery or hand/wrist fracture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a device to reduce symptoms of cubital tunnel syndrome without surgery, by measuring pain, numbness & weakness.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly stated here, potential side effects may include skin irritation from wearing the device or discomfort due to posture adjustment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have had surgery on my spine or hand, or I've had a hand/wrist fracture.

Select...

I have had type 2 diabetes for a long time and suffer from nerve pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in pain score for numbness using a Visual Analogue Scale (VAS)

Change in pain score for pain using a Visual Analogue Scale (VAS)

Change in pain score for weakness using a Visual Analogue Scale (VAS)

Secondary study objectives

Change in Boston Carpal Tunnel Syndrome (BCTS) questionnaire

Change in Medical Research Council (MRC) Scale for Muscle Strength

Change in Semmes-Weinstein monofilament testing.

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: normal conservative management + posture trainingExperimental Treatment1 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 Control1 Intervention

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

0 / 4Eligibility criteria met