Posture Correction in Cubital Tunnel Syndrome

Yale University

Status: Suspended

Conditions: Cubital Tunnel Syndrome

Treatments: Device: UpRight Go

Study type: Interventional

Funder types: Other

Identifiers

NCT06095011

2000036074

000

Details and patient eligibility

About

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.

Full description

This is a randomized controlled, non-blinded trial. All patients who are eligible to participate and who consent to participate will be randomized to either receive standard of care treatment alone, or standard of care treatment with the additional intervention of posture training. The nature of the intervention prevents blinding. All patients will be followed for 6 weeks and evaluated for symptom improvement or resolution.

All patients aged 18 and older who present to clinic with cubital tunnel syndrome of any severity and who have not previously undergone surgical intervention for this condition will be eligible to participate in this study. All participants must be amenable to conservative management of CuTS, wearing a posture training device daily, completing the accompanying questionnaires throughout the study, and returning for follow-up.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

normal conservative management + posture training

Experimental group

Description:

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.

Treatment:

Device: UpRight Go

normal conservative management only (standard of care)

No Intervention group

Description:

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