Isometric Intervention for Lateral Elbow Tendinopathy

• ClinicalTrials.gov Identifier: NCT03756155
• Recruitment Status: Recruiting
• First Posted: November 28, 2018
• Last Update Posted: May 21, 2020
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

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.

Condition or disease	Intervention/treatment	Phase
Lateral Elbow Tendinopathy; Elbow Pain; Elbows Tendonitis; Elbow Sprain; Elbow Injury	Procedure: isometric intervention	Phase 1; Phase 2

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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)
• Primary Purpose: Treatment
• Official Title: The Immediate Effects on Pain Levels After an Isometric Intervention for Individuals With Lateral Elbow Tendinopathy
• Actual Study Start Date: December 31, 2018
• Actual Primary Completion Date: December 31, 2019
• Estimated Study Completion Date: December 31, 2020

Arms and Interventions

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 Name: 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 Name: Midrofet hand held dynamometer

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Chee Vang, MD; 952-944-5314; cvang26@fairview.org

Locations

United States, Minnesota

University of Minnesota; Recruiting

Minneapolis, Minnesota, United States, 55455

Contact: Chee Vang, MD 952-944-5314 cvang26@fairview.org

Sponsors and Collaborators

University of Minnesota

Investigators

• Principal Investigator: Chee Vang, MD; University of Minnesota

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT03756155
• Other Study ID Numbers: STUDY00004723
• First Posted: November 28, 2018
• Last Update Posted: May 21, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Tendinopathy; Elbow Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries