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Isometric Intervention for Lateral Elbow Tendinopathy

Primary Purpose

Lateral Elbow Tendinopathy, Elbow Pain, Elbows Tendonitis

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
isometric intervention
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Elbow Tendinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
November 26, 2018
Last Updated
March 25, 2022
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT03756155
Brief Title
Isometric Intervention for Lateral Elbow Tendinopathy
Official Title
The Immediate Effects on Pain Levels After an Isometric Intervention for Individuals With Lateral Elbow Tendinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
PI no longer at the institution; departmental permission to deactivate study
Study Start Date
December 31, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Elbow Tendinopathy, Elbow Pain, Elbows Tendonitis, Elbow Sprain, Elbow Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
isometric intervention
Other Intervention Name(s)
Midrofet hand held dynamometer
Intervention Description
The research participants will perform isometric repetitions against the hand held dynamometer
Primary Outcome Measure Information:
Title
Assess efficacy: NRS
Description
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).
Time Frame
Randomization through 12 months
Secondary Outcome Measure Information:
Title
Assess correlation between force output during max grip strength testing and reported pain levels
Description
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.
Time Frame
Randomization through 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chee Vang, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Isometric Intervention for Lateral Elbow Tendinopathy

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