← 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,853 Previous Clinical Trials

2,738,521 Total Patients Enrolled

Elspeth Hill, MBChB, PhD, MRes, MRCSPrincipal InvestigatorYale University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts for this clinical exploration still ongoing?

"According to the information on clinicaltrials.gov, this medical study is no longer recruiting participants. The trial was first advertised on October 1st 2023 and had it's last update sixteen days later. Fortunately, 1485 other trials are still taking in enrollees at this moment in time."

Answered by AI

What goals has this research endeavor been designed to accomplish?

"The primary outcome of this clinical trial which is monitored over Baseline and 6 weeks will be the alteration in numbness-related pain assessed via Visual Analogue Scale (VAS). Secondary objectives include a shift in strength testing through pinch/grip test, an adjustment to Medical Research Council (MRC) Scale for Muscle Strength, and changes documented during range of motion testing. Pinch testing entails using a pinchmeter to measure the patient's grip whereas Grip assessment requires utilizing a dynamometer that measures force exerted on it with higher readings implying greater power. MRC rating ranges from Grade 5 representing normalcy all the way down to 0 suggesting quad"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Posture Correction in Cubital Tunnel Syndrome

2023. "Posture Correction in Cubital Tunnel Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06095011.

All > Orthopedic