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Trial record 95 of 337 for:    Charcot Marie Tooth

Effectiveness of Nerve Glide Exercises on Cubital Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT03629470
Recruitment Status : Not yet recruiting
First Posted : August 14, 2018
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Cubital Tunnel Syndrome Other: Standard Conservative Treatment Other: Nerve Gliding Exercises Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Nerve Glide Exercises on Cubital Tunnel Syndrome
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019


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




Primary Outcome Measures :
  1. Clinical Scoring [ Time Frame: 1 Month ]
    30 item questionnaire used as a clinical scoring system.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629470


Contacts
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Contact: Steven Glickel 212 658 1122 steven.glickel@nyumc.org

Locations
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United States, New York
New York University School of Medicine Not yet recruiting
New York, New York, United States, 10016
Contact: Steven Glickel    212-658-1122    steven.glickel@nyumc.org   
Principal Investigator: Louis Catalano, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Louis Catalano, MD NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03629470     History of Changes
Other Study ID Numbers: 17-01734
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ulnar Nerve Compression Syndromes
Nerve Compression Syndromes
Cubital Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Ulnar Neuropathies
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries