NCT07385677

Brief Summary

Lateral elbow pain can significantly limit people's ability to do the activities they want or need to do. We want to explore if one treatment technique is better than another for people with lateral elbow pain. You will be placed in a traditional treatment group or in a non-traditional treatment group. Your placement in the group will depend on past treatments you have had for this pain. Before you start treatment, you will be given four tests: 1) a grip strength test, 2) a pinch test, 3) a pain level survey, and 4) a functional survey. These four tests will take no longer than 15 minutes to complete. These four tests are common tests given to people with elbow pain. You will be given these four tests:

  • At the beginning, before you start treatment
  • At 2-weeks
  • At 4-weeks
  • At the end of your treatment Traditional treatment group: You will receive treatment 1x/week for 4-6 weeks. The traditional treatment group will consist of the following treatments:
  • stretching and strengthening of the wrist extensors
  • soft tissue work to the forearm muscles
  • joint mobilization at the elbow
  • rigid and elastic taping with focus on the wrist extensor muscles
  • ergonomic strategies
  • transcutaneous electrical nerve stimulation (TENS)
  • wrist splinting Non-traditional (TINLL) treatment group: You will receive treatment 1x/every 1-2-weeks for 4-6 weeks. The non-traditional (TINLL) treatment group will consist of the following treatments:
  • joint and tendon mobilization at the elbow
  • elastic tape for muscles and nerves
  • stretching/strengthening of the muscles at the elbow and upper arm
  • ergonomic strategies

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Nov 2024Nov 2026

Study Start

First participant enrolled

November 26, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2026

Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

January 26, 2026

Last Update Submit

February 2, 2026

Conditions

Keywords

lateral elbow painradial nerve

Outcome Measures

Primary Outcomes (3)

  • Patient rated tennis elbow evaluation (PRTEE)

    15-item, self-report questionnaire designed to measure pain and disability in patients with lateral elbow tendinopathy (tennis elbow).

    Day 1, 2-week appointment, 4-week appointment

  • pain-free grip strength

    pain-free grip strength using Jamar dynamometer

    Day 1, 2-week appointment, 4-week appointment

  • numeric rating scale for pain

    pain scale

    Day 1, 2-week appointment, 4-week appointment

Secondary Outcomes (1)

  • 3-jaw pinch

    Day 1, 2-week appointment, 4-week appointment

Study Arms (2)

TINLL

EXPERIMENTAL

* radial head mobilization * biceps tendon mobilization with movement to address joint alignment, neural tension, and the superficial sensory nervous system. * elastic tape cross fiber inhibition 50% stretch over distal biceps * elastic tape radial head stabilization with 80% stretch * biceps stretching/lengthening * pectoralis major stretching * scapular strengthening * triceps and supinator strengthening * ergonomic strategies

Other: TINLL techniques for relieving radial nerve tension

Traditional

ACTIVE COMPARATOR

* stretching of the wrist extensors * isometric, concentric, and/or eccentric strengthening of the finger extensors, wrist extensors, pronator, and supinator muscles * elbow joint manipulation or mobilization (such as mobilization with movement (MWM) as developed by Mulligan) * soft tissue mobilization techniques to the forearm muscles * instrument-assisted soft tissue mobilization (IASTM) to the forearm muscles * rigid taping techniques and elastic taping application as part of a multimodal treatment program focused on common extensors * ergonomic strategies * transcutaneous electrical nerve stimulation (TENS) * wrist orthosis/splinting

Other: Traditional techniques to stretch and strengthen muscles

Interventions

1x/week for 4-6 weeks or less if patient responds well to the treatment

TINLL

1x/week for 4-6 weeks unless patients responds well to treatment

Traditional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • understanding of English language; adults 18 years of age or older
  • referral for lateral sided elbow pain or lateral epicondylitis
  • subjects positive on one of the following (tenderness over lateral epicondyle with palpation
  • pain with stretch of long wrist extensors
  • pain with resisted wrist or middle finger extension)

You may not qualify if:

  • subjects unable to cognitively follow directions
  • have a legally-mandated reporter
  • subjects scheduled for surgery, or post-up surgical patients
  • subjects with carpal tunnel syndrome, cubital tunnel syndrome/medial elbow pain,
  • subjects who received Platelet-Rich Plasma (PRP) or percutaneous needle tenotomy (PNT)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopedica and Rehabilitation Center - Occupational Therapy/Hand Therapy, University of Vermont Medical Center

South Burlington, Vermont, 05403, United States

RECRUITING

Related Publications (3)

  • Taylor A, Wolff AL. The forgotten radial nerve: A conceptual framework for treatment of lateral elbow pain. J Hand Ther. 2021 Apr-Jun;34(2):323-329. doi: 10.1016/j.jht.2021.05.009. Epub 2021 Jun 27.

    PMID: 34193382BACKGROUND
  • Lucado AM, Day JM, Vincent JI, MacDermid JC, Fedorczyk J, Grewal R, Martin RL. Lateral Elbow Pain and Muscle Function Impairments. J Orthop Sports Phys Ther. 2022 Dec;52(12):CPG1-CPG111. doi: 10.2519/jospt.2022.0302.

    PMID: 36453071BACKGROUND
  • Degen RM, Conti MS, Camp CL, Altchek DW, Dines JS, Werner BC. Epidemiology and Disease Burden of Lateral Epicondylitis in the USA: Analysis of 85,318 Patients. HSS J. 2018 Feb;14(1):9-14. doi: 10.1007/s11420-017-9559-3. Epub 2017 Jun 5.

    PMID: 29398988BACKGROUND

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Central Study Contacts

Victoria Priganc, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 4, 2026

Study Start

November 26, 2024

Primary Completion (Estimated)

November 26, 2026

Study Completion (Estimated)

November 26, 2026

Last Updated

February 4, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Data will only be shared via presentations and/or publications.

Locations