- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05537636
Physical Therapy on Non-structural Medial Elbow Pain
Effect of Regional Interdepence Physical Therapy Approach on Non-structural Medial Elbow Pain
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Tim L Uhl, PhD, University of Kentucky
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 60696
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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