Clinical trial NCT03756155: Isometric Intervention for Lateral Elbow Tendinopathy
Official title: The Immediate Effects on Pain Levels After an Isometric Intervention for Individuals With Lateral Elbow Tendinopathy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Lateral Elbow Tendinopathy
Elbow Pain
Elbows Tendonitis
Elbow Sprain
Elbow Injury
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Assess efficacy: NRS
timeFrame: Randomization through 12 months
Secondary outcomes:
measure: Assess correlation between force output during max grip strength testing and reported pain levels
timeFrame: Randomization through 12 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Chee Vang, MD
role: PRINCIPAL_INVESTIGATOR
References: