Lateral Elbow TendinopathyPhase 1/2NCT03756155
Isometric Intervention for Lateral Elbow Tendinopathy
A Phase 1/2 study testing isometric intervention in people with Lateral Elbow Tendinopathy and Elbow Pain, run by University of Minnesota at 1 site in United States.
Trial summary
This study will be looking at people with lateral elbow tendinopathy (elbow pain). The goal is to determine if a one-time isometric intervention will positively change the level of pain and strength as compared to baseline measurements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Elbow Tendinopathy, Elbow Pain, Elbows Tendonitis
- What is being tested?
- isometric intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2018to 31 Dec 2020
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 18 years old or older
- Currently has lateral elbow pain
- If bilateral lateral elbow pain is present, the more symptomatic side will be assessed
- At the time of presentation, individuals have been evaluated as having clinical diagnosed LET for at least 4 weeks
- AND: Positive pain response to at least two of the following tests:
- Pain with palpation on the affected elbow
Show all 9Show fewer
- Pain with resisted wrist or middle finger extension
- Pain while stretching the lateral forearm muscles (Mills Test)
- At least 30% deficit of pain-free grip compared with the unaffected side
Who cannot join
- - Radicular/Cervical conditions reproducing elbow symptoms
- rheumatoid arthritis
- Other elbow pathologies: bursitis, medial epicondylalgia, radial nerve entrapment, posterolateral rotary instability
- History of fracture to the radius, ulna, or humerus with resultant deformity of the involved extremity
- History of an injection within 6 months
- Inability to place the shoulder, elbow and wrist in the required testing position
- The affected elbow had been operated on
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: The Immediate Effects on Pain Levels After an Isometric Intervention for Individuals With Lateral Elbow Tendinopathy
This study will be looking at people with lateral elbow tendinopathy (elbow pain). The goal is to determine if a one-time isometric intervention will positively change the level of pain and strength as compared to baseline measurements. After determining baseline strength and pain level, an intervention consisting of several trials of isometric hand/wrist contractions will be performed by the participant. Pain and strength will again be assessed immediately after the intervention.
Read the detailed description
Participants will be randomized into two different groups in 10 participant blocks, meaning after every 10 participants eligible and completing the study, there will be 5 participants assigned to each group. Group 1 will complete a protocol with 10 sets of 10 second isometric holds followed by 10 second rest intervals between sets. Each repetition will be performed as closely to the targeted 30%-40% value. Group 2 will complete a protocol with 5 sets of 20 second isometric holds followed by 20 second rest intervals between sets. Each repetition will be performed as closely to the targeted 30% value. Resistance for both testing conditions will be performed against the examiner's external resistance/against the Microfet hand held dynamometer. Immediately after the intervention, all participants will again repeat their maximal grip on their affected arm using the Jamar hand held dynamometer and will grade their pain level. (The protocol will be identical to the pre testing procedure from above). The pain score and force output will be obtained and documented. Once these steps are complete, testing will cease. All participants will be instructed to follow their referring provider's treatment intervention.
- Being tested
- isometric intervention
- Medical subject headings
- Elbow Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isometric interventionProcedure or surgery
Also called Midrofet hand held dynamometer
The research participants will perform isometric repetitions against the hand held dynamometer
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1 will complete a protocol with 10 sets of 10 second isometric holds followed by 10 second rest intervals between sets. Each repetition will be performed as closely to the targeted 30%-40% value. Receives: Procedure: isometric intervention |
| Group 2 | Experimental | Group 2 will complete a protocol with 5 sets of 20 second isometric holds followed by 20 second rest intervals between sets. Each repetition will be performed as closely to the targeted 30% value. Receives: Procedure: isometric intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess efficacy: NRS
To assess the immediate effects of an isometric intervention on pain levels for individuals with lateral elbow tendinopathy. The primary outcome measure that will be utilized is the Numeric Pain Rating Scale (NRS) which will measure pain intensity using the 11 point scale with values ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: Randomization through 12 months
Secondary outcomes (1)
Assess correlation between force output during max grip strength testing and reported pain levels
To determine if there is a correlation between force output during max grip strength testing and reported pain levels, and to determine if there is a correlation between two different time under tension protocols and max grip strength and reported pain levels. The secondary outcome measure with be grip strength, both pain free and max grip strength which will be measured in pounds using a Jamar handheld dynamometer.
Measured: Randomization through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start31 Dec 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2020 (estimated)
Why it stopped: PI no longer at the institution; departmental permission to deactivate study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Elbow TendinopathyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into two different groups (Group 1 and Group 2) in 10 participant blocks, meaning after every 10 participants eligible and completing the study, there will be 5 participants assigned to each group.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chee Vang, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756155
- Sponsor's protocol ID
- STUDY00004723
- Status last verified
- Mar 2022
- First submitted
- 26 Nov 2018
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Effects on Pain Levels After an Isometric Intervention for Individuals With Lateral Elbow Tendinopathy
- ClinicalTrials.gov ID
- NCT03756155
- Acronym / sponsor ID
- STUDY00004723
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI no longer at the institution; departmental permission to deactivate study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 31 Dec 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 28 Nov 2018 (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.
This study will be looking at people with lateral elbow tendinopathy (elbow pain). The goal is to determine if a one-time isometric intervention will positively change the level of pain and strength as compared to baseline measurements. After determining baseline strength and pain level, an intervention consisting of several trials of isometric hand/wrist contractions will be performed by the participant. Pain and strength will again be assessed immediately after the intervention.
Detailed description
Participants will be randomized into two different groups in 10 participant blocks, meaning after every 10 participants eligible and completing the study, there will be 5 participants assigned to each group. Group 1 will complete a protocol with 10 sets of 10 second isometric holds followed by 10 second rest intervals between sets. Each repetition will be performed as closely to the targeted 30%-40% value. Group 2 will complete a protocol with 5 sets of 20 second isometric holds followed by 20 second rest intervals between sets. Each repetition will be performed as closely to the targeted 30% value. Resistance for both testing conditions will be performed against the examiner's external resistance/against the Microfet hand held dynamometer. Immediately after the intervention, all participants will again repeat their maximal grip on their affected arm using the Jamar hand held dynamometer and will grade their pain level. (The protocol will be identical to the pre testing procedure from above). The pain score and force output will be obtained and documented. Once these steps are complete, testing will cease. All participants will be instructed to follow their referring provider's treatment intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized into two different groups (Group 1 and Group 2) in 10 participant blocks, meaning after every 10 participants eligible and completing the study, there will be 5 participants assigned to each group.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: isometric interventionGroup 1 will complete a protocol with 10 sets of 10 second isometric holds followed by 10 second rest intervals between sets. Each repetition will be performed as closely to the targeted 30%-40% value. |
| Group 2 | Experimental | Procedure: isometric interventionGroup 2 will complete a protocol with 5 sets of 20 second isometric holds followed by 20 second rest intervals between sets. Each repetition will be performed as closely to the targeted 30% value. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- - 18 years old or older
- Currently has lateral elbow pain
- If bilateral lateral elbow pain is present, the more symptomatic side will be assessed
- At the time of presentation, individuals have been evaluated as having clinical diagnosed LET for at least 4 weeks
- AND: Positive pain response to at least two of the following tests:
Key exclusion criteria (7 listed)
- - Radicular/Cervical conditions reproducing elbow symptoms
- rheumatoid arthritis
- Other elbow pathologies: bursitis, medial epicondylalgia, radial nerve entrapment, posterolateral rotary instability
- History of fracture to the radius, ulna, or humerus with resultant deformity of the involved extremity
- History of an injection within 6 months
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 |
|---|---|---|
| isometric interventionAlso: Midrofet hand held dynamometerThe research participants will perform isometric repetitions against the hand held dynamometer | Procedure or surgery | Group 1, Group 2 |
Primary outcome
Assess efficacy: NRS
Time frame: Randomization through 12 months
To assess the immediate effects of an isometric intervention on pain levels for individuals with lateral elbow tendinopathy. The primary outcome measure that will be utilized is the Numeric Pain Rating Scale (NRS) which will measure pain intensity using the 11 point scale with values ranging from 0 (no pain) to 10 (worst imaginable pain).
1 secondary outcome
Assess correlation between force output during max grip strength testing and reported pain levels
Time frame: Randomization through 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Chee Vang, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing isometric intervention in people with Lateral Elbow Tendinopathy and Elbow Pain, run by University of Minnesota 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 9 inclusion and 7 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: withdrawn, as of the sponsor's last update on 5 Apr 2022. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Assess efficacy: NRS (time frame: Randomization through 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2022.