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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03629470
Other study ID # 17-01734
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 9, 2020
Est. completion date December 28, 2021

Study information

Verified date September 2022
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date December 28, 2021
Est. primary completion date December 28, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patients diagnosed with cubital tunnel syndrome on physical exam Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Standard Conservative Treatment
Range of motion exercises, medication and activity modification.
Nerve Gliding Exercises
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

Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Scoring 30 item questionnaire used as a clinical scoring system. 1 Month
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