Cubital Tunnel SyndromeNCT06095011
Posture Correction in Cubital Tunnel Syndrome
A study testing UpRight Go in people with Cubital Tunnel Syndrome, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cubital Tunnel Syndrome
- What is being tested?
- UpRight Go
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2023to 24 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06520
About this study
Official title: Posture Correction for the Treatment of Cubital Tunnel Syndrome (CuTS)
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.
Read the 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.
- Conditions
- Cubital Tunnel Syndrome
- Being tested
- UpRight Go
- Medical subject headings
- Cubital Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UpRight GoDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 6 weeks
Secondary outcomes (9)
Change in The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
The DASH questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. Each item is scored on a 5 point Likert scale. Total score ranges from 0 (no disability) to 100 (most severe disability). Higher scores indicate a greater level of disability and severity.
Measured: Baseline and 6 weeks
Change in strength testing via pinch/grip test
Pinch testing involves the patient pinching a pinchmeter, which measures the strength of the patient's pinch. Grip testing involves the patient gripping a dynamometer. The force that the patient is able to exert on the pinchmeter/dynamometer is measured in lbs/kgs, Newtons, or Pascals, and a higher reading indicates a greater strength. This provides valuable information about how a patient's strength is affected by cubital tunnel syndrome.
Measured: Baseline and 6 weeks
Change in Medical Research Council (MRC) Scale for Muscle Strength
The MRC Scale is a commonly used scale for assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction). This score was defined as the sum of MRC scores from six muscles in the upper and lower limbs on both sides so that the score ranged from 60 (normal) to 0 (quadriplegic). The Criteria requires that each of the six muscle groups listed in the table are examined bilaterally.
Measured: Baseline and 6 weeks
Change in range of motion testing
Patients will be asked to actively move their upper body through a series of movements and postures, testing for flexibility in the neck, shoulders, elbows, and wrists. Limitations in movement are recorded qualitatively, which indicates the potential presence of concomitant pathology in the upper extremities, which could affect a patient's response to treatment.
Measured: Baseline and 6 weeks
Change in two-point discrimination testing
A caliper or two point discriminator is used to apply pressure to a patient's finger tips. The patient is then asked to determine if one or two points of pressure are present, with the distance between the two points changing. The lowest distance between two points that the patient can distinguish is recorded in millimeters. A smaller distance indicates better fine-touch sensation at the finger tips and can indicate the quality of sensory nerves at the distal upper extremity.
Measured: Baseline and 6 weeks
Change in Semmes-Weinstein monofilament testing.
The Semmes-Weinstein monofilament (SWM) testing is one of the clinical tests that measures the response to a touching sensation of the monofilaments using a numerical quantity. The monofilament is a small strand of nylon attached to a plastic base at fixed spacing's from 2mm to 15mm. The provider uses this monofilament to check for loss of feeling on your foot.
Measured: Baseline and 6 weeks
Change in Boston Carpal Tunnel Syndrome (BCTS) questionnaire
The BCTS is a patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. The Symptom Severity Scale (SSS) with 11 questions is scored on a Likert scale of 1-5 and the Functional Status Scale (FSS) with 8 questions is scored from 1-5 with 1 as no difficulty and 5 as difficult. A final score is calculated for each scale (the sum of the individual scores divided by the number of items) and ranges from 1 to 5, with a higher score indicating a more severe handicap.
Measured: Baseline and 6 weeks
Hours per day device was worn
The mean hours per day device was worn
Measured: up to 6 weeks
Time spent with good posture
The mean time spent with good posture while wearing the device
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start15 Dec 2023
- Primary completion24 Jul 2024
- Study completion24 Jul 2024
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cubital Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be recruited through occupational hand therapy clinics throughout the Yale New Haven Hospital system
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elspeth Hill, MBChB, PhD, MRes, MRCS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095011
- Sponsor's protocol ID
- 2000036074
- Other IDs
- 000
- Status last verified
- Sep 2026
- First submitted
- 16 Oct 2023
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posture Correction for the Treatment of Cubital Tunnel Syndrome (CuTS)
- ClinicalTrials.gov ID
- NCT06095011
- Acronym / sponsor ID
- 2000036074
- Conditions
- Cubital Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of funding
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be recruited through occupational hand therapy clinics throughout the Yale New Haven Hospital system
| Arm | Type | Receives |
|---|---|---|
| normal conservative management + posture training | Experimental | Device: UpRight GoParticipants 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. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UpRight GoThe 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. | Device | normal conservative management + posture training |
Primary outcome
Change in pain score for pain using a Visual Analogue Scale (VAS)
Time frame: Baseline and 6 weeks
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.
Change in pain score for numbness using a Visual Analogue Scale (VAS)
Time frame: Baseline and 6 weeks
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.
Change in pain score for weakness using a Visual Analogue Scale (VAS)
Time frame: Baseline and 6 weeks
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.
9 secondary outcomes
Change in The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
Time frame: Baseline and 6 weeks
Change in strength testing via pinch/grip test
Time frame: Baseline and 6 weeks
Change in Medical Research Council (MRC) Scale for Muscle Strength
Time frame: Baseline and 6 weeks
Change in range of motion testing
Time frame: Baseline and 6 weeks
Change in two-point discrimination testing
Time frame: Baseline and 6 weeks
Change in Semmes-Weinstein monofilament testing.
Time frame: Baseline and 6 weeks
Change in Boston Carpal Tunnel Syndrome (BCTS) questionnaire
Time frame: Baseline and 6 weeks
Hours per day device was worn
Time frame: up to 6 weeks
Time spent with good posture
Time frame: up to 6 weeks
Results and safety
The study was stopped early (reason given: lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elspeth Hill, MBChB, PhD, MRes, MRCS principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UpRight Go in people with Cubital Tunnel Syndrome, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain score for pain using a Visual Analogue Scale (VAS) (time frame: Baseline and 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.