Effectiveness of Nerve Glide Exercises on Cubital Tunnel Syndrome
1 other identifier
interventional
2
1 country
1
Brief Summary
The objective of this study is to determine if nerve glide exercises in patients with cubital tunnel syndrome can improve pain, paraesthesias and reduce the need for future surgery. Cubital tunnel syndrome is a common form of peripheral neuropathy caused by compression of the ulnar nerve at the elbow. Surgical intervention is typically reserved for those with severe symptoms, but many cases can be treated with non-operative measures. This study will look at the efficacy of nerve glide exercises in the management of cubital tunnel syndrome. 70 subjects with cubital tunnel syndrome will be enrolled and randomized into groups receiving either standard conservative measures or standard measures in addition to nerve glide exercises. Outcomes will be measured 6 months after initiation of treatment with questionnaires on clinical symptoms and function to see if there is a difference between the two groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2018
CompletedFirst Posted
Study publicly available on registry
August 14, 2018
CompletedStudy Start
First participant enrolled
November 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2021
CompletedSeptember 7, 2022
September 1, 2022
1.1 years
August 9, 2018
September 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Scoring
30 item questionnaire used as a clinical scoring system.
1 Month
Study Arms (2)
Group 1
ACTIVE COMPARATORstandard conservative treatment
Group 2
EXPERIMENTALnerve gliding exercises along with the standard conservative treatment.
Interventions
Range of motion exercises, medication and activity modification.
Taught by occupational therapist. These exercises involve motions of the wrist, arm and neck. Subjects will be instructed to perform exercises regularly following the occupational therapists' protocol
Eligibility Criteria
You may qualify if:
- Patients diagnosed with cubital tunnel syndrome on physical exam
You may not qualify if:
- Patients with diagnosed or self-reported cognitive dysfunction
- Patients who are unable to understand or follow commands
- Any patient that the investigators feel unsafe or cannot comply with all study related procedures
- Patients who had previous ulnar nerve release at the elbow
- Patients with documented cervical spine pathology
- Patients with clinical signs of other nerve pathology
- Patients with palpable subluxation of the ulnar nerve at the elbow
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University School of Medicine
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Louis Catalano, MD
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2018
First Posted
August 14, 2018
Study Start
November 9, 2020
Primary Completion
December 28, 2021
Study Completion
December 28, 2021
Last Updated
September 7, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share