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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
Sponsored by
Timothy Uhl
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
August 11, 2022
Last Updated
November 17, 2022
Sponsor
Timothy Uhl
Collaborators
Bluegrass Orthopedics
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
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.
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
Baseline and every 5th visit up to discharge which is estimated to be 3 months on average
Title
Change in Focus On Therapeutic Outcome (FOTO) Patient Outcme Score
Description
Patient self-report of perceived level of function. Scores range from 0 = low function, to 100=high function.
Time Frame
Baseline and every 5th visit up to discharge which is estimated to be 3 months on average
Title
Change in Lower Trapezius scapular muscle strength
Description
Objectively measure with hand held dynamometer for scapular retraction
Time Frame
Baseline and every 5th visit up to discharge which is estimated to be 3 months on average
Secondary Outcome Measure Information:
Title
Change in Elbow Flexion Range of Motion in Ulnar Nerve Tension position
Description
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.
Time Frame
Baseline and every 5th visit up to discharge which is estimated to be 3 months on average
Title
Change in Elbow Extension Range of Motion in Median Nerve Tension positoin
Description
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.
Time Frame
Baseline and every 5th visit up to discharge which is estimated to be 3 months on average

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tim L Uhl, PhD
Phone
859-218-0858
Email
tluhl2@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim L Uhl, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bluegrass Orthopaedics
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle McCallum, DPT
Phone
859-577-9162
Email
michelle.mccallum@bluegrassortho.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24421619
Citation
Sueki DG, Cleland JA, Wainner RS. A regional interdependence model of musculoskeletal dysfunction: research, mechanisms, and clinical implications. J Man Manip Ther. 2013 May;21(2):90-102. doi: 10.1179/2042618612Y.0000000027.
Results Reference
result
PubMed Identifier
28878485
Citation
Wickstrom BM, Oakley PA, Harrison DE. Non-surgical relief of cervical radiculopathy through reduction of forward head posture and restoration of cervical lordosis: a case report. J Phys Ther Sci. 2017 Aug;29(8):1472-1474. doi: 10.1589/jpts.29.1472. Epub 2017 Aug 10.
Results Reference
result
PubMed Identifier
24685569
Citation
Day JM, Willoughby J, Pitts DG, McCallum M, Foister R, Uhl TL. Outcomes following the conservative management of patients with non-radicular peripheral neuropathic pain. J Hand Ther. 2014 Jul-Sep;27(3):192-9; quiz 200. doi: 10.1016/j.jht.2014.02.003. Epub 2014 Feb 27.
Results Reference
result
PubMed Identifier
12544957
Citation
Wainner RS, Fritz JM, Irrgang JJ, Boninger ML, Delitto A, Allison S. Reliability and diagnostic accuracy of the clinical examination and patient self-report measures for cervical radiculopathy. Spine (Phila Pa 1976). 2003 Jan 1;28(1):52-62. doi: 10.1097/00007632-200301010-00014.
Results Reference
result
PubMed Identifier
22402638
Citation
Nee RJ, Jull GA, Vicenzino B, Coppieters MW. The validity of upper-limb neurodynamic tests for detecting peripheral neuropathic pain. J Orthop Sports Phys Ther. 2012 May;42(5):413-24. doi: 10.2519/jospt.2012.3988. Epub 2012 Mar 8.
Results Reference
result

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Physical Therapy on Non-structural Medial Elbow Pain

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