Isometric Intervention for Lateral Elbow Tendinopathy

NCT03756155 | Withdrawn Phase 1

• 1 other identifier: STUDY00004723
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assess correlation between force output during max grip strength testing and reported pain levels

  Randomization through 12 months

Study Arms (2)

Group 1

EXPERIMENTAL

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

Group 2

EXPERIMENTAL

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

Interventions

isometric intervention PROCEDURE

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

Also known as: Midrofet hand held dynamometer

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Elbow Injuries

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries

Study Officials

• Chee Vang, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 28, 2018
• Study Start: December 31, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: April 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)