Isometric Intervention for Lateral Elbow Tendinopathy

NCT ID: NCT03756155

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-31
• Study Completion Date: 2020-12-31

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.

Conditions

Lateral Elbow Tendinopathy; Elbow Pain; Elbows Tendonitis; Elbow Sprain; Elbow Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

isometric intervention

Intervention Type: PROCEDURE

The research participants will perform isometric repetitions against the hand held dynamometer

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.

Group Type: EXPERIMENTAL

isometric intervention

Intervention Type: PROCEDURE

The research participants will perform isometric repetitions against the hand held dynamometer

Interventions

isometric intervention

The research participants will perform isometric repetitions against the hand held dynamometer

Intervention Type: PROCEDURE

Other Intervention Names

Midrofet hand held dynamometer

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chee Vang, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

STUDY00004723

Identifier Type: -

Identifier Source: org_study_id