Back to resultsPosture Correction in Cubital Tunnel Syndrome
Primary Purpose
Cubital Tunnel Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
UpRight Go
Sponsored by
About this trial
This is an interventional supportive care trial for Cubital Tunnel Syndrome
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
Sites / Locations
- Yale New Haven Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
normal conservative management + posture training
normal conservative management only (standard of care)
Arm 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.
Participants will receive conservative management.only: standard of care for initial treatment of cubital tunnel syndrome
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Hours per day device was worn
The mean hours per day device was worn
Time spent with good posture
The mean time spent with good posture while wearing the device
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06095011
Brief Title
Posture Correction in Cubital Tunnel Syndrome
Official Title
Posture Correction for the Treatment of Cubital Tunnel Syndrome (CuTS)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cubital Tunnel Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be recruited through occupational hand therapy clinics throughout the Yale New Haven Hospital system
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
normal conservative management + posture training
Arm Type
Experimental
Arm 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.
Arm Title
normal conservative management only (standard of care)
Arm Type
No Intervention
Arm Description
Participants will receive conservative management.only: standard of care for initial treatment of cubital tunnel syndrome
Intervention Type
Device
Intervention Name(s)
UpRight Go
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in pain score for pain using a Visual Analogue Scale (VAS)
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change in pain score for numbness using a Visual Analogue Scale (VAS)
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change in pain score for weakness using a Visual Analogue Scale (VAS)
Description
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.
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Change in The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change in strength testing via pinch/grip test
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change in Medical Research Council (MRC) Scale for Muscle Strength
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change in range of motion testing
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change in two-point discrimination testing
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change in Semmes-Weinstein monofilament testing.
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change in Boston Carpal Tunnel Syndrome (BCTS) questionnaire
Description
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.
Time Frame
Baseline and 6 weeks
Title
Hours per day device was worn
Description
The mean hours per day device was worn
Time Frame
up to 6 weeks
Title
Time spent with good posture
Description
The mean time spent with good posture while wearing the device
Time Frame
up to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elspeth Hill, MBChB, PhD, MRes, MRCS
Phone
314-827-7307
Email
elspeth.hill@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elspeth Hill, MBChB, PhD, MRes, MRCS
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Posture Correction in Cubital Tunnel Syndrome
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