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Effectiveness of Nerve Glide Exercises on Cubital Tunnel Syndrome

Primary Purpose

Cubital Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Conservative Treatment
Nerve Gliding Exercises
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cubital Tunnel Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group 1

Group 2

Arm Description

standard conservative treatment

nerve gliding exercises along with the standard conservative treatment.

Outcomes

Primary Outcome Measures

Clinical Scoring
30 item questionnaire used as a clinical scoring system.

Secondary Outcome Measures

Full Information

First Posted
August 9, 2018
Last Updated
September 1, 2022
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03629470
Brief Title
Effectiveness of Nerve Glide Exercises on Cubital Tunnel Syndrome
Official Title
Effectiveness of Nerve Glide Exercises on Cubital Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
November 9, 2020 (Actual)
Primary Completion Date
December 28, 2021 (Actual)
Study Completion Date
December 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
standard conservative treatment
Arm Title
Group 2
Arm Type
Experimental
Arm Description
nerve gliding exercises along with the standard conservative treatment.
Intervention Type
Other
Intervention Name(s)
Standard Conservative Treatment
Intervention Description
Range of motion exercises, medication and activity modification.
Intervention Type
Other
Intervention Name(s)
Nerve Gliding Exercises
Intervention Description
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
Primary Outcome Measure Information:
Title
Clinical Scoring
Description
30 item questionnaire used as a clinical scoring system.
Time Frame
1 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis Catalano, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of Nerve Glide Exercises on Cubital Tunnel Syndrome

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