Posture Correction in Cubital Tunnel Syndrome

NCT06095011 | Suspended

• 2 other identifiers: 2000036074000
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cubital Tunnel Syndrome

Outcome Measures

Primary Outcomes (3)

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

  Pain score assessed using a linear VAS: a straight horizontal line of fixed length (100mm) on which participants will mark the point on the line that they feel represents their perception of their current state. The VAS score is determined by measuring, in millimeters, from the left hand end of the line to the point that the patient marks. The scale ranges from "no pain" to "severe pain". The longer the distance on the line, the more pain.

  Baseline and 6 weeks

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

  Pain score for numbness assessed using a linear VAS: a straight horizontal line of fixed length (100mm) on which participants will mark the point on the line that they feel represents their perception of their current state. The VAS score is determined by measuring, in millimeters, from the left hand end of the line to the point that the patient marks. The scale ranges from "no pain" to "severe pain". The longer the distance on the line, the more pain.

  Baseline and 6 weeks

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

  Pain score for weakness assessed using a linear VAS: a straight horizontal line of fixed length (100mm) on which participants will mark the point on the line that they feel represents their perception of their current state. The VAS score is determined by measuring, in millimeters, from the left hand end of the line to the point that the patient marks. The scale ranges from "no pain" to "severe pain". The longer the distance on the line, the more pain.

  Baseline and 6 weeks

Secondary Outcomes (9)

• Change in The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire

  Baseline and 6 weeks

• Change in strength testing via pinch/grip test

  Baseline and 6 weeks

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

  Baseline and 6 weeks

• Change in range of motion testing

  Baseline and 6 weeks

• Change in two-point discrimination testing

  Baseline and 6 weeks

Study Arms (2)

normal conservative management + posture training

EXPERIMENTAL

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.

Device: UpRight Go

normal conservative management only (standard of care)

NO INTERVENTION

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

Interventions

UpRight Go DEVICE

The UpRight Go posture trainer is a commercially available biofeedback sensor that externally attaches to the wearer via a necklace or silicon adhesive. It vibrates when it senses that the wearer is slouching and connects to a smartphone application which sets daily goals, tracks usage, and provides assistance and support. It complies with International Electrotechnical Commission (IEC) standards.

normal conservative management + posture training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Adult patients, between 18 and 99 years old
• 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.
• Nerve conduction study, electromyography, MRI or ultrasound results consistent with the diagnosis of cubital tunnel syndrome
• Ability to wear a posture trainer daily and manage the associated smartphone application and questionnaire

You may not qualify if:

• History of spinal surgery, hand surgery or hand/wrist fracture
• History of cubital tunnel release surgery or carpal tunnel syndrome
• Pregnancy or lactation
• Known allergic reactions to silicon
• Long-standing history of T2DM, documented neuropathic pain

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Cubital Tunnel Syndrome

Condition Hierarchy (Ancestors)

Ulnar Neuropathies; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Ulnar Nerve Compression Syndromes; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Elspeth Hill, MBChB, PhD, MRes, MRCS

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be recruited through occupational hand therapy clinics throughout the Yale New Haven Hospital system

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: December 15, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)