Isometric Intervention for Lateral Elbow Tendinopathy

Phase 1

Withdrawn

• Conditions: Elbow Sprain; Lateral Elbow Tendinopathy; Elbow Injury; Elbow Pain; Elbows Tendonitis
• Interventions: Procedure: isometric intervention

• Registration Number: NCT03756155
• Lead Sponsor: University of Minnesota

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-28
• Study Start: 2018-12-31
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-25
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	isometric intervention	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	isometric intervention	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.

Primary Outcome Measures

Name	Time	Method
Assess efficacy: NRS	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

Name	Time	Method
Assess correlation between force output during max grip strength testing and reported pain levels	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States