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.
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
- Conditions the study is for
- Lateral Elbow Tendinopathy (Tennis Elbow)
- 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.
United States1 site, 1 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 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.
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
pain-free grip strength
pain-free grip strength using Jamar dynamometer
Measured: Day 1, 2-week appointment, 4-week appointment
numeric rating scale for pain
pain scale
Measured: Day 1, 2-week appointment, 4-week appointment
Secondary outcomes (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.
- First posted4 Feb 2026
- Study start26 Nov 2024
- Primary completion26 Nov 2026 (estimated)
- Study completion26 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lateral Elbow Tendinopathy (Tennis Elbow)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victoria Priganc, University of Vermont
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 34193382Lucado 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 36453071Degen 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of the 'Think in Nerve Length and Layers' (TINLL) Approach to Traditional Treatment for Patients With Lateral Elbow Pain.
- ClinicalTrials.gov ID
- NCT07385677
- Acronym / sponsor ID
- IRB00003117
- Keywords
- lateral elbow pain, radial nerve
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 26 Nov 2026 (estimated)
- Study completion
- 26 Nov 2026 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TINLL | Experimental | Other: TINLL techniques for relieving radial nerve tension* 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 |
| Traditional | Active comparator | Other: Traditional techniques to stretch and strengthen muscles* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TINLL techniques for relieving radial nerve tension1x/week for 4-6 weeks or less if patient responds well to the treatment | Other | TINLL |
| Traditional techniques to stretch and strengthen muscles1x/week for 4-6 weeks unless patients responds well to treatment | Other | Traditional |
Primary outcome
Patient rated tennis elbow evaluation (PRTEE)
Time frame: Day 1, 2-week appointment, 4-week appointment
15-item, self-report questionnaire designed to measure pain and disability in patients with lateral elbow tendinopathy (tennis elbow).
pain-free grip strength
Time frame: Day 1, 2-week appointment, 4-week appointment
pain-free grip strength using Jamar dynamometer
numeric rating scale for pain
Time frame: Day 1, 2-week appointment, 4-week appointment
pain scale
1 secondary outcome
3-jaw pinch
Time frame: Day 1, 2-week appointment, 4-week appointment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Background: PubMed 34193382Taylor 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.
- Background: PubMed 36453071Lucado 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.
- Background: PubMed 29398988Degen 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.
- Individual participant dataSharing planned: No. Data will only be shared via presentations and/or publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.