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Physical Therapy on Non-structural Medial Elbow Pain

Primary Purpose

Elbow Injuries and Disorders, Neuritis, Ulnar, Neuritis, Brachial

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Rehabiltiation using exercise and manual therapy

About this trial

This is an interventional treatment trial for Elbow Injuries and Disorders focused on measuring Regional Interdependence, Posture, Neural Tension, Physical Therapy

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Bluegrass OrthopaedicsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Regional Interdepence Intervention for the upper quarter

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Cervical Range of Motion in extension

Inclinometer measurement of cervical extension

Change in Focus On Therapeutic Outcome (FOTO) Patient Outcme Score

Patient self-report of perceived level of function. Scores range from 0 = low function, to 100=high function.

Change in Lower Trapezius scapular muscle strength

Objectively measure with hand held dynamometer for scapular retraction

Secondary Outcome Measures

Change in Elbow Flexion Range of Motion in Ulnar Nerve Tension position

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.

Change in Elbow Extension Range of Motion in Median Nerve Tension positoin

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.

Full Information

NCT ID

NCT05537636

First Posted

August 11, 2022

Last Updated

November 17, 2022

Sponsor

Timothy Uhl

Collaborators

Bluegrass Orthopedics

1. Study Identification

Unique Protocol Identification Number

NCT05537636

Brief Title

Physical Therapy on Non-structural Medial Elbow Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2022 (Actual)

Primary Completion Date

October 30, 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Timothy Uhl

Collaborators

Bluegrass Orthopedics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Elbow Injuries and Disorders, Neuritis, Ulnar, Neuritis, Brachial, Neuritis; Nerve Root, Neuritis Median Nerve

Keywords

Regional Interdependence, Posture, Neural Tension, Physical Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Cohort longitudinal

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Regional Interdepence Intervention for the upper quarter

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Rehabiltiation using exercise and manual therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Cervical Range of Motion in extension

Description

Inclinometer measurement of cervical extension

Time Frame