Skip to main content
OpenTrials
Completed

NCT Number: NCT02971072

Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subacromial injection

Procedure

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

Physical Therapy

Other

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

Primary outcomes

  1. Rotator cuff activation after subacromial injection and exercise intervention, difference in rotator cuff voluntary activation between subjects and controls

    Time frame: 6 weeks

    Assessed using voluntary activation

  2. Rotator cuff activation after subacromial injection and exercise intervention, difference in specific rotator cuff muscle activation between subjects and controls

    Time frame: 6 weeks

    Assessed using electromyography (EMG)

Secondary outcomes

  1. Rotator cuff voluntary activation after subacromial injection

    Time frame: 2 hours

    Assessed using voluntary activation

  2. Rotator cuff muscle activation after subacromial injection

    Time frame: 2 hours

    Assessed using EMG

  3. Rotator cuff voluntary activation correlations with pain levels

    Time frame: 2 hours

    Assessed using voluntary activation relative to self-reported pain level

  4. Rotator cuff activation correlations with pain levels

    Time frame: 2 hours

    Assessed using EMG relative to self-reported pain level

  5. Rotator cuff voluntary activation after 6-week exercise intervention and subacromial injection

    Time frame: 6 weeks

    Assessed using voluntary activation

  6. Rotator cuff muscle activation after 6-week exercise intervention and subacromial injection

    Time frame: 6 weeks

    Assessed using EMG

  7. Rotator cuff voluntary activation correlation with improvements in pain relief

    Time frame: 6 weeks

    Assessed using voluntary activation relative to self-reported pain relief

  8. Rotator cuff voluntary activation correlation with improvements in clinical outcome measures

    Time frame: 6 weeks

    Assessed using voluntary activation relative to changes in questionnaire scores

  9. Rotator cuff muscle activation correlation with improvements in pain relief

    Time frame: 6 weeks

    Assessed using EMG relative to self-reported pain relief

  10. Rotator cuff muscle activation correlation with improvements in clinical outcome measures

    Time frame: 6 weeks

    Assessed using EMG relative to changes in questionnaire scores

  11. Prior to treatment, rotator cuff voluntary activation in patients relative to healthy controls

    Time frame: 6 weeks

    Assessed using voluntary activation

  12. Prior to treatment, rotator cuff muscle activation in patients relative to healthy controls

    Time frame: 6 weeks

    Assessed using EMG

  13. After both a subacromial injection and a six-week exercise program, differences in rotator cuff voluntary activation between patients and healthy controls

    Time frame: 6 weeks

    Assessed using voluntary activation

  14. After both a subacromial injection and a six-week exercise program, differences in rotator cuff muscle activation between patients and healthy controls

    Time frame: 6 weeks

    Assessed using EMG

Sponsors and collaborators

Lead sponsor

University of Oregon

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Nov 22, 2016
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.