Clinical trial NCT02971072: Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy
Official title: Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Atrophic
Goals
Impairment
Infiltration
Injury
Muscle Weakness
Pain
Pathology
Shoulder Pain
Syndrome
Tendinopathy
Keywords: address
atrophic
base
clinical
cost
data
disability
effectiveness
attention
biofeedback
electrical stimulation
electromyography
exercise
exertion
health care service utilization
improved
injection of therapeutic agent
innovation
intervention
knowledge
local anesthetics
measures
modeling
motor
motor control
muscle
neuroadaptation
neurophysiology
novel
outcome
outcome measure
pain inhibition
patients
pattern
programs
public health relevance
rehabilitation strategy
relating to nervous system
reporting
research
rotator cuff
shoulder
staging
strength training
success
systematic review
techniques
testing
time
training
treatment strategy
United States
work
Lead sponsor: University of Oregon
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2016-11-22
Enrollment: 180
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine deficits in activation and motor patterns, as well as central drive in patients with rotator cuff tendinopathy. There are three specific aims: (1) determine the effect of acute pain relief on rotator cuff muscle activation in patients with rotator cuff tendinopathy, (2) determine the effect of exercise on rotator cuff muscle activation in patients with rotator cuff tendinopathy, and (3) compare rotator cuff muscle activation between patients with rotator cuff tendinopathy and healthy controls.

Detailed description: The long-term goal of our research agenda is to identify the mechanisms associated with rotator cuff tendinopathy (impingement syndrome) and subsequently evaluate novel treatment strategies that address these mechanisms. The objectives of this application are to study the muscle patterns in patients with rotator cuff tendinopathy as well as the effects of both pain and exercise on these patterns. Our first hypothesis is that pain relief from a shoulder injection will result in increased rotator cuff activity. Our second hypothesis is that patients with tendinopathy will demonstrate improved rotator cuff muscle activity following a six-week exercise program and that this improvement will be higher in patients that respond favorably to treatment. Our final hypothesis is that patients with cuff tendinopathy will show decreased rotator cuff activity compared to healthy subjects. The investigators plan on addressing these hypotheses using several novel techniques for muscle activity assessment.

Eligibility criteria: Patient Inclusion Criteria:

* pain with passive provocative maneuvers (positive Hawkins or Neer test)
* pain with active elevation (positive painful arc)
* pain with isometric resisted movements (Jobe's "empty can" test or resisted shoulder external rotation with the arm at the side)
* demonstrate weakness (\>10% force deficit in external rotation)

Patient Exclusion Criteria:

* shoulder surgery on the symptomatic side
* positive Spurling test
* traumatic shoulder dislocation or instability in the past 3 months
* reproduction of shoulder pain with active or passive cervical range of motion
* signs of rotator cuff tear (drop-arm test, lag signs, gross external rotation weakness, or positive image findings)
* current musculoskeletal, neurologic or cardiovascular compromise

Control Inclusion Criteria:

* no current or previous shoulder injury
* matched for age (within 5 years) and sex
* meet Patient Exclusion Criteria (minus musculoskeletal, neurologic, or cardiovascular compromise)

Control Exclusion Criteria:

* pain with active arm elevation
* positive Hawkins, Neer, or Jobe's test

Primary outcomes:
measure: Rotator cuff activation after subacromial injection and exercise intervention, difference in rotator cuff voluntary activation between subjects and controls
timeFrame: 6 weeks
measure: Rotator cuff activation after subacromial injection and exercise intervention, difference in specific rotator cuff muscle activation between subjects and controls
timeFrame: 6 weeks
Secondary outcomes:
measure: Rotator cuff voluntary activation after subacromial injection
timeFrame: 2 hours
measure: Rotator cuff muscle activation after subacromial injection
timeFrame: 2 hours
measure: Rotator cuff voluntary activation correlations with pain levels
timeFrame: 2 hours
measure: Rotator cuff activation correlations with pain levels
timeFrame: 2 hours
measure: Rotator cuff voluntary activation after 6-week exercise intervention and subacromial injection
timeFrame: 6 weeks
measure: Rotator cuff muscle activation after 6-week exercise intervention and subacromial injection
timeFrame: 6 weeks
measure: Rotator cuff voluntary activation correlation with improvements in pain relief
timeFrame: 6 weeks
measure: Rotator cuff voluntary activation correlation with improvements in clinical outcome measures
timeFrame: 6 weeks
measure: Rotator cuff muscle activation correlation with improvements in pain relief
timeFrame: 6 weeks
measure: Rotator cuff muscle activation correlation with improvements in clinical outcome measures
timeFrame: 6 weeks
measure: Prior to treatment, rotator cuff voluntary activation in patients relative to healthy controls
timeFrame: 6 weeks
measure: Prior to treatment, rotator cuff muscle activation in patients relative to healthy controls
timeFrame: 6 weeks
measure: After both a subacromial injection and a six-week exercise program, differences in rotator cuff voluntary activation between patients and healthy controls
timeFrame: 6 weeks
measure: After both a subacromial injection and a six-week exercise program, differences in rotator cuff muscle activation between patients and healthy controls
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Eugene
country: United States
facility: University of Oregon
state: Oregon
Study officials:
affiliation: University of Oregon
name: Andrew R Karduna, PhD
role: PRINCIPAL_INVESTIGATOR
References: