NCT03629470

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
2.2 years until next milestone

Study Start

First participant enrolled

November 9, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2021

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

1.1 years

First QC Date

August 9, 2018

Last Update Submit

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 COMPARATOR

standard conservative treatment

Other: Standard Conservative Treatment

Group 2

EXPERIMENTAL

nerve gliding exercises along with the standard conservative treatment.

Other: Standard Conservative TreatmentOther: Nerve Gliding Exercises

Interventions

Range of motion exercises, medication and activity modification.

Group 1Group 2

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

Group 2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Cubital Tunnel Syndrome

Condition Hierarchy (Ancestors)

Ulnar NeuropathiesMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesUlnar Nerve Compression SyndromesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Officials

  • Louis Catalano, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

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

Locations