Clinical trial NCT06095011: Posture Correction in Cubital Tunnel Syndrome
Official title: Posture Correction for the Treatment of Cubital Tunnel Syndrome (CuTS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cubital Tunnel Syndrome
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be recruited through occupational hand therapy clinics throughout the Yale New Haven Hospital system
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain score for pain using a Visual Analogue Scale (VAS)
timeFrame: Baseline and 6 weeks
measure: Change in pain score for numbness using a Visual Analogue Scale (VAS)
timeFrame: Baseline and 6 weeks
measure: Change in pain score for weakness using a Visual Analogue Scale (VAS)
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change in The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
timeFrame: Baseline and 6 weeks
measure: Change in strength testing via pinch/grip test
timeFrame: Baseline and 6 weeks
measure: Change in Medical Research Council (MRC) Scale for Muscle Strength
timeFrame: Baseline and 6 weeks
measure: Change in range of motion testing
timeFrame: Baseline and 6 weeks
measure: Change in two-point discrimination testing
timeFrame: Baseline and 6 weeks
measure: Change in Semmes-Weinstein monofilament testing.
timeFrame: Baseline and 6 weeks
measure: Change in Boston Carpal Tunnel Syndrome (BCTS) questionnaire
timeFrame: Baseline and 6 weeks
measure: Hours per day device was worn
timeFrame: up to 6 weeks
measure: Time spent with good posture
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Elspeth Hill, MBChB, PhD, MRes, MRCS
role: PRINCIPAL_INVESTIGATOR
References: