Physical Therapy on Non-structural Medial Elbow Pain

November 20, 2023 updated by: Timothy Uhl

Effect of Regional Interdepence Physical Therapy Approach on Non-structural Medial Elbow Pain

This study is investigating the effect of using a regional interdependence approach of managing non-structural elbow pain with physical therapy.

Study Overview

Detailed Description

Potential patients will be referred for physical therapy with elbow nerve pain arising from a non-structural lesion. We believe by addressing spine and trunk posture and mobility we can relieve elbow pain associated with a nerve compression with physical therapy.

Patients will be put on a staged exercise program to regain spinal mobility and strengthen proximal core musculature and scapular musculature. Manual therapy to facilitate mobility will be incorporated. Patients will undergo standard physical therapy by an unblinded therapist until resolution of symptoms.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Tim L Uhl, PhD
  • Phone Number: 859-218-0858
  • Email: tluhl2@uky.edu

Study Locations

    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Bluegrass Orthopaedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The patient presents with elbow pain that is not exacerbated with resisted wrist flexion, extension, supination, or pronation.
  • The patient presents with elbow pain that is not exacerbated with passive wrist flexion or extension.
  • The patient presents with three of the four positive cervical radicular signs
  • Patient presents with peripheral paresthesia

Exclusion Criteria:

  • The patient reports a surgical history involving the elbow.
  • The patient has an MRI that is positive for structural deficits within the upper extremity.
  • The patient self-reports a diagnosis of rheumatoid arthritis or other neurological systemic diseases such as Parkinson's disease, cerebrovascular accident, multiple sclerosis, or similar conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regional Interdepence Intervention for the upper quarter
Physical therapist will perform interventions to the entire uppper extremity and spine to treat elbow pain. Physical therapy intervention will include manual therapy and soft-tissue massage to the shoulder, cervical, and thoracic spine. Participants will be prescribed specific exercises using a phased approach.

A licensed Physical Therapist will provide manual therapy to help restore spinal and scapular mobility. In association with this patients will be prescribed home exercises using a phased approach.

Phase 1 to gain mobility of the spine and scapular motor control Phase 2 to gain shoulder mobility to strengthen scapular and spine musculature Phase 3 shoulder strengthening with long lever arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cervical Range of Motion in extension
Time Frame: Baseline and every 5th visit up to discharge which is estimated to be 3 months on average
Inclinometer measurement of cervical extension
Baseline and every 5th visit up to discharge which is estimated to be 3 months on average
Change in Focus On Therapeutic Outcome (FOTO) Patient Outcme Score
Time Frame: Baseline and every 5th visit up to discharge which is estimated to be 3 months on average
Patient self-report of perceived level of function. Scores range from 0 = low function, to 100=high function.
Baseline and every 5th visit up to discharge which is estimated to be 3 months on average
Change in Lower Trapezius scapular muscle strength
Time Frame: Baseline and every 5th visit up to discharge which is estimated to be 3 months on average
Objectively measure with hand held dynamometer for scapular retraction
Baseline and every 5th visit up to discharge which is estimated to be 3 months on average

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Elbow Flexion Range of Motion in Ulnar Nerve Tension position
Time Frame: Baseline and every 5th visit up to discharge which is estimated to be 3 months on average
Goniometric measure using a standard plastic goniometer with patient plased In nerve tension position that bias tension on ulnar nerve. The standard upper limb tension test position described by Magee' Orthopaedic Physical Assessment 7th edition. The angle of elbow flexion that reproduces symptoms will be recorded. Values will range from 0-150 degrees with a higher numbers indicating less symptoms.
Baseline and every 5th visit up to discharge which is estimated to be 3 months on average
Change in Elbow Extension Range of Motion in Median Nerve Tension positoin
Time Frame: Baseline and every 5th visit up to discharge which is estimated to be 3 months on average
Goniometric measure using a standard plastic goniometer with patient plased In nerve tension position that bias tension on median nerve. The standard upper limb tension test position described by Magee' Orthopaedic Physical Assessment 7th edition. The angle of elbow extension that reproduces symptoms will be recorded. Values will range from 0-150 degrees with a lower numbers indicating less symptoms.
Baseline and every 5th visit up to discharge which is estimated to be 3 months on average

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Tim L Uhl, PhD, University of Kentucky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

August 30, 2023

Study Completion (Actual)

August 30, 2023

Study Registration Dates

First Submitted

August 11, 2022

First Submitted That Met QC Criteria

September 12, 2022

First Posted (Actual)

September 13, 2022

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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