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Lateral Elbow Tendinopathy (Tennis Elbow)NCT07385677

Comparing the Effectiveness of the 'Think in Nerve Length and Layers' (TINLL) Approach to Traditional Treatment for Patients With Lateral Elbow Pain.

A study testing TINLL techniques for relieving radial nerve tension and Traditional techniques to stretch and strengthen muscles in people with Lateral Elbow Tendinopathy (Tennis Elbow), run by University of Vermont at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TINLL techniques for relieving radial nerve tension and Traditional techniques to stretch and strengthen muscles
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteUnited States
Study dates
26 Nov 2024to 26 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Victoria Priganc, PhD contact

802-777-1477

victoria.priganc@med.uvm.edu

United States1 site, 1 recruiting
  • Orthopedica and Rehabilitation Center - Occupational Therapy/Hand Therapy, University of Vermont Medical Center

    South Burlington, Vermont, 05403

    Chelsea Witt, MS, 802-847-7910, chelsea.witt@uvmhealth.org

    Jennifer Elsinger, BS, 802-847-7910, jennifer.elsinger@uvmhealth.org

    Recruiting

Other trials in United States

About this study

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.

Read more

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
Read the detailed description

Upon referral for lateral elbow pain, two schedulers will look at the referral and consult with the study co-investigators to decide what group they should be assigned to based on past medical treatment for lateral elbow pain. The schedulers will have a script they read over the phone to the patients. This will be part of the usual call. At this point, patients do not need to decide whether or not to participate; they are just introduced to the study. Upon arrival for their appointment, the scheduler will introduce the study again to the patient and the patient will be given the opportunity to watch a short video on an approved IPad. This closed-captioned video will provide details of the study and patients will watch the video in a treatment room. After watching the video, the co-investigators will review the consent form and ask the participant if they have any questions. Those subjects that agree to participate will sign the consent form, thus consenting to participate. Those subjects who do not agree to participate will still receive treatment.

Once consent is obtained, subjects will be assigned to either the TINLL group or the traditional treatment and given a research ID number. Once assigned to a group, the therapist in charge of that group will perform the following assessments at the initial visit: numerical rating scale for pain (NRS), patient-rated tennis elbow evaluation (PRTEE), one pain free grip strength with extended elbow and pronated forearm (strength number recorded), and one 3-jaw pinch max effort (pain level and strength number recorded). Regardless of group assignment, all subjects will undergo these assessments at the initial visit. Following the assessments, subjects will begin either the TINLL or the traditional treatment group. Subjects will be assessed at the initial visit, 2-week visit, and 4-week visit and the same assessments will be administered by the same therapist. After the 4-week visit, subjects can opt to switch groups if they choose to do so. These visits described below are regular standard of care intervals. If a subject requires additional visits beyond what is listed below, the subject will be excluded from the study and will receive needed care and billed according to standard practices.

Treatment for the TINLL group will be 1x every 1-2-weeks for 4-6 weeks and consists of a combination of the following depending on the patient:

  • 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

Additional treatments may be considered. These include:

  • techniques for relieving radial nerve tension (instrument-assisted soft tissue mobilization (IASTM), silicone cup gliding)
  • radial nerve taping from dorsal thenar muscle to C7 on stretch (10%).

The home exercise program for this group includes biceps inhibition tape, radial head stabilization tape, and isometric strengthening triceps/supination (dosing = 1-2 sets/day for 8 reps).

Treatment for the traditional treatment group will be 1x every week for 4-6 weeks and will consist of a combination of the following depending on the patient:

  • 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
  • The home exercise program for this group includes extrinsic stretches for wrist extensors (3 reps, 30 sec holds, 1 time/day) and strengthening (dosing = 3 sets of 15 repetitions 1x/day)

Following 1-month of treatment in either group, subjects will be given the opportunity to switch groups.

6-mo following treatment, subjects will be contacted via phone and asked follow-up questions related pain, function (via the PRTEE), use of taping, and use of home exercises.

Being tested
TINLL techniques for relieving radial nerve tension, Traditional techniques to stretch and strengthen muscles
Keywords
lateral elbow pain, radial nerve
Medical subject headings
Tennis Elbow

What participants receive

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

  • TINLL techniques for relieving radial nerve tensionOther

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

  • Traditional techniques to stretch and strengthen musclesOther

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

Study groups in NCT07385677
Study groupRoleWhat they receive
TINLLExperimental* 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
Receives: Other: TINLL techniques for relieving radial nerve tension
TraditionalActive 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
Receives: Other: Traditional techniques to stretch and strengthen muscles

What is being measured

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

  1. 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).

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

  2. pain-free grip strength

    pain-free grip strength using Jamar dynamometer

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

  3. numeric rating scale for pain

    pain scale

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

Secondary outcomes (1)
  1. 3-jaw pinch

    pinch measurement

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

Timeline

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

  1. First posted4 Feb 2026
  2. Study start26 Nov 2024
  3. Primary completion26 Nov 2026 (estimated)
  4. Study completion26 Nov 2026 (estimated)

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07385677
Sponsor's protocol ID
IRB00003117
Status last verified
Jan 2026
First submitted
26 Jan 2026
Last updated
4 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will only be shared via presentations and/or publications.

Publications

  • 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.

    PubMed 34193382
  • 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.

    PubMed 36453071
  • 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.

    PubMed 29398988

Questions about this trial

What is this clinical trial studying?

A study testing TINLL techniques for relieving radial nerve tension and Traditional techniques to stretch and strengthen muscles in people with Lateral Elbow Tendinopathy (Tennis Elbow), run by University of Vermont 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 4 Feb 2026. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Victoria Priganc, PhD (802-777-1477, victoria.priganc@med.uvm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient rated tennis elbow evaluation (PRTEE) (time frame: Day 1, 2-week appointment, 4-week appointment). 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 NCT07385677, which also lists 3 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 4 Feb 2026.

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