Isometric Intervention for Lateral Elbow Tendinopathy

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• Status: Withdrawn
• Conditions: Elbow Sprain; Elbow Injury; Elbows Tendonitis; Elbow Pain; Lateral Elbow Tendinopathy
• Intervention / Treatment: Procedure: isometric 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 Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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).	Randomization through 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Randomization through 12 months

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Chee Vang, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: March 25, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Elbow Tendinopathy
• Other Study ID 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