Effectiveness of Nerve Glide Exercises on Cubital Tunnel Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Cubital Tunnel Syndrome
• Intervention / Treatment: Other: Standard Conservative Treatment; Other: Nerve Gliding Exercises

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; standard conservative treatment	Other: Standard Conservative Treatment; Range of motion exercises, medication and activity modification.
Experimental: Group 2; nerve gliding exercises along with the standard conservative treatment.	Other: Standard Conservative Treatment; Range of motion exercises, medication and activity modification.; Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Scoring	30 item questionnaire used as a clinical scoring system.	1 Month

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Louis Catalano, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Actual): December 28, 2021
• Study Completion (Actual): December 28, 2021

Study Registration Dates

• First Submitted: August 9, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Ulnar Nerve Compression Syndromes; Ulnar Neuropathies; Syndrome; Cubital Tunnel Syndrome
• Other Study ID Numbers: 17-01734

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No