Isometric Intervention for Lateral Elbow Tendinopathy

March 25, 2022 updated by: University of Minnesota

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • - 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
    • 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

Exclusion Criteria:

  • - 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1
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.
Procedure: isometric intervention
The research participants will perform isometric repetitions against the hand held dynamometer
Other Names:
  • Midrofet hand held dynamometer
Experimental: Group 2
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.
Procedure: isometric intervention
The research participants will perform isometric repetitions against the hand held dynamometer
Other Names:
  • Midrofet hand held dynamometer

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Randomization through 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assess correlation between force output during max grip strength testing and reported pain levels
Time Frame: Randomization through 12 months
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.
Randomization through 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chee Vang, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 31, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00004723

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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