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Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy

Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02971072
Enrollment
180
Registered
2016-11-22
Start date
2014-07-31
Completion date
2021-04-30
Last updated
2022-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

A subacromial injection consisting up 6 cc 0.5% Marcaine with Epinephrine and 1 cc DepoMedrol will be administered.

OTHERPhysical Therapy

A standardized six-week exercise protocol supervised by a physical therapist

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
University of Oregon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Rotator cuff activation after subacromial injection and exercise intervention, difference in rotator cuff voluntary activation between subjects and controls6 weeksAssessed using voluntary activation
Rotator cuff activation after subacromial injection and exercise intervention, difference in specific rotator cuff muscle activation between subjects and controls6 weeksAssessed using electromyography (EMG)

Secondary

MeasureTime frameDescription
Rotator cuff voluntary activation correlations with pain levels2 hoursAssessed using voluntary activation relative to self-reported pain level
Rotator cuff activation correlations with pain levels2 hoursAssessed using EMG relative to self-reported pain level
Rotator cuff voluntary activation after 6-week exercise intervention and subacromial injection6 weeksAssessed using voluntary activation
Rotator cuff muscle activation after 6-week exercise intervention and subacromial injection6 weeksAssessed using EMG
Rotator cuff voluntary activation correlation with improvements in pain relief6 weeksAssessed using voluntary activation relative to self-reported pain relief
Rotator cuff voluntary activation correlation with improvements in clinical outcome measures6 weeksAssessed using voluntary activation relative to changes in questionnaire scores
Rotator cuff voluntary activation after subacromial injection2 hoursAssessed using voluntary activation
Rotator cuff muscle activation correlation with improvements in clinical outcome measures6 weeksAssessed using EMG relative to changes in questionnaire scores
Prior to treatment, rotator cuff voluntary activation in patients relative to healthy controls6 weeksAssessed using voluntary activation
Prior to treatment, rotator cuff muscle activation in patients relative to healthy controls6 weeksAssessed using EMG
After both a subacromial injection and a six-week exercise program, differences in rotator cuff voluntary activation between patients and healthy controls6 weeksAssessed using voluntary activation
After both a subacromial injection and a six-week exercise program, differences in rotator cuff muscle activation between patients and healthy controls6 weeksAssessed using EMG
Rotator cuff muscle activation correlation with improvements in pain relief6 weeksAssessed using EMG relative to self-reported pain relief
Rotator cuff muscle activation after subacromial injection2 hoursAssessed using EMG

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026