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CompletedNCT05537636Updated Nov 22, 2023

Physical Therapy on Non-structural Medial Elbow Pain

An interventional study of Rehabiltiation using exercise and manual therapy in Elbow Injuries and Disorders, Neuritis, Ulnar and Neuritis, Brachial, sponsored by Timothy Uhl. Completed at 1 site in United States. Open to participants aged 15 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-11-22.

Sponsored by Timothy Uhl · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
15 Years to 50 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

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

Keywords

  • Regional Interdependence
  • Posture
  • Neural Tension
  • Physical Therapy
03

In context

Elbow Injuries

21 studies on the registry are indexed under Elbow Injuries; 6 are open to participants now.

This study's enrollment of 22 is below the median of 52 across 13 interventional studies indexed under Elbow Injuries.

Browse Elbow Injuries studies →

Lead sponsor

Timothy Uhl is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • 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.

    Other: Rehabiltiation using exercise and manual therapy

Interventions

  • OtherRehabiltiation using exercise and manual therapy

    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.

06

What researchers measure

Primary outcomes

  1. Change in Cervical Range of Motion in extension

    Inclinometer measurement of cervical extension

    Time frame: Baseline and every 5th visit up to discharge which is estimated to be 3 months on average

  2. 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.

    Time frame: Baseline and every 5th visit up to discharge which is estimated to be 3 months on average

  3. Change in Lower Trapezius scapular muscle strength

    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 outcomes

  1. 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.

    Time frame: Baseline and every 5th visit up to discharge which is estimated to be 3 months on average

  2. 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.

    Time frame: Baseline and every 5th visit up to discharge which is estimated to be 3 months on average

07

Study locations

1 site
  • Bluegrass Orthopaedics
    Lexington, Kentucky 40509, United States
08

References and documents

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. PubMed 24421619 ↗
  • 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. PubMed 28878485 ↗
  • 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. PubMed 24685569 ↗
  • 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. PubMed 12544957 ↗
  • 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. PubMed 22402638 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05537636
Lead sponsor
Timothy Uhl
Collaborators
Bluegrass Orthopedics
Responsible party
Timothy Uhl (Professor, University of Kentucky) — Sponsor-investigator
First posted
Sep 13, 2022
Start date
Oct 1, 2022
Primary completion
Aug 30, 2023
Completion
Aug 30, 2023
Last update
Nov 22, 2023

Study contacts

Tim L Uhl, PhD
principal investigator · University of Kentucky

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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