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Elbow Injuries and DisordersNCT05537636

Physical Therapy on Non-structural Medial Elbow Pain

A study testing Rehabiltiation using exercise and manual therapy in people with Elbow Injuries and Disorders and Neuritis, Ulnar, run by Timothy Uhl at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 15 to 50 years
What is being tested?
Rehabiltiation using exercise and manual therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
1 Oct 2022to 30 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Bluegrass Orthopaedics

    Lexington, Kentucky, 40509

Other trials in United States

About this study

Official title: 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.

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.

Being tested
Rehabiltiation using exercise and manual therapy
Keywords
Regional Interdependence, Posture, Neural Tension, Physical Therapy
Medical subject headings
Elbow Injuries, Disease, Ulnar Neuropathies, Brachial Plexus Neuritis, Neuritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rehabiltiation using exercise and manual therapyOther

    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.

Study groups in NCT05537636
Study groupRoleWhat they receive
Regional Interdepence Intervention for the upper quarterExperimentalPhysical 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.
Receives: Other: Rehabiltiation using exercise and manual therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Cervical Range of Motion in extension

    Inclinometer measurement of cervical extension

    Measured: 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.

    Measured: 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

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

Secondary outcomes (2)

  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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2022
  2. Study start1 Oct 2022
  3. Primary completion30 Aug 2023
  4. Study completion30 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Cohort longitudinal
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05537636
Sponsor's protocol ID
60696
Status last verified
Nov 2023
First submitted
11 Aug 2022
Last updated
22 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Rehabiltiation using exercise and manual therapy in people with Elbow Injuries and Disorders and Neuritis, Ulnar, run by Timothy Uhl at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05537636, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.

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