search
Back to results

Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy

Primary Purpose

Acute Pain, Atrophic, Goals

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Subacromial injection
Physical Therapy
Sponsored by
University of Oregon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring 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

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Oregon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients

Arm Description

Subjects with shoulder tendinopathy who will undergo both a subacromial injection and physical therapy

Outcomes

Primary Outcome Measures

Rotator cuff activation after subacromial injection and exercise intervention, difference in rotator cuff voluntary activation between subjects and controls
Assessed using voluntary activation
Rotator cuff activation after subacromial injection and exercise intervention, difference in specific rotator cuff muscle activation between subjects and controls
Assessed using electromyography (EMG)

Secondary Outcome Measures

Rotator cuff voluntary activation after subacromial injection
Assessed using voluntary activation
Rotator cuff muscle activation after subacromial injection
Assessed using EMG
Rotator cuff voluntary activation correlations with pain levels
Assessed using voluntary activation relative to self-reported pain level
Rotator cuff activation correlations with pain levels
Assessed using EMG relative to self-reported pain level
Rotator cuff voluntary activation after 6-week exercise intervention and subacromial injection
Assessed using voluntary activation
Rotator cuff muscle activation after 6-week exercise intervention and subacromial injection
Assessed using EMG
Rotator cuff voluntary activation correlation with improvements in pain relief
Assessed using voluntary activation relative to self-reported pain relief
Rotator cuff voluntary activation correlation with improvements in clinical outcome measures
Assessed using voluntary activation relative to changes in questionnaire scores
Rotator cuff muscle activation correlation with improvements in pain relief
Assessed using EMG relative to self-reported pain relief
Rotator cuff muscle activation correlation with improvements in clinical outcome measures
Assessed using EMG relative to changes in questionnaire scores
Prior to treatment, rotator cuff voluntary activation in patients relative to healthy controls
Assessed using voluntary activation
Prior to treatment, rotator cuff muscle activation in patients relative to healthy controls
Assessed using EMG
After both a subacromial injection and a six-week exercise program, differences in rotator cuff voluntary activation between patients and healthy controls
Assessed using voluntary activation
After both a subacromial injection and a six-week exercise program, differences in rotator cuff muscle activation between patients and healthy controls
Assessed using EMG

Full Information

First Posted
May 10, 2016
Last Updated
September 7, 2022
Sponsor
University of Oregon
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
search

1. Study Identification

Unique Protocol Identification Number
NCT02971072
Brief Title
Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy
Official Title
Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
April 2021 (Actual)
Study Completion Date
April 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oregon
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm Description
Subjects with shoulder tendinopathy who will undergo both a subacromial injection and physical therapy
Intervention Type
Procedure
Intervention Name(s)
Subacromial injection
Intervention Description
A subacromial injection consisting up 6 cc 0.5% Marcaine with Epinephrine and 1 cc DepoMedrol will be administered.
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Intervention Description
A standardized six-week exercise protocol supervised by a physical therapist
Primary Outcome Measure Information:
Title
Rotator cuff activation after subacromial injection and exercise intervention, difference in rotator cuff voluntary activation between subjects and controls
Description
Assessed using voluntary activation
Time Frame
6 weeks
Title
Rotator cuff activation after subacromial injection and exercise intervention, difference in specific rotator cuff muscle activation between subjects and controls
Description
Assessed using electromyography (EMG)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Rotator cuff voluntary activation after subacromial injection
Description
Assessed using voluntary activation
Time Frame
2 hours
Title
Rotator cuff muscle activation after subacromial injection
Description
Assessed using EMG
Time Frame
2 hours
Title
Rotator cuff voluntary activation correlations with pain levels
Description
Assessed using voluntary activation relative to self-reported pain level
Time Frame
2 hours
Title
Rotator cuff activation correlations with pain levels
Description
Assessed using EMG relative to self-reported pain level
Time Frame
2 hours
Title
Rotator cuff voluntary activation after 6-week exercise intervention and subacromial injection
Description
Assessed using voluntary activation
Time Frame
6 weeks
Title
Rotator cuff muscle activation after 6-week exercise intervention and subacromial injection
Description
Assessed using EMG
Time Frame
6 weeks
Title
Rotator cuff voluntary activation correlation with improvements in pain relief
Description
Assessed using voluntary activation relative to self-reported pain relief
Time Frame
6 weeks
Title
Rotator cuff voluntary activation correlation with improvements in clinical outcome measures
Description
Assessed using voluntary activation relative to changes in questionnaire scores
Time Frame
6 weeks
Title
Rotator cuff muscle activation correlation with improvements in pain relief
Description
Assessed using EMG relative to self-reported pain relief
Time Frame
6 weeks
Title
Rotator cuff muscle activation correlation with improvements in clinical outcome measures
Description
Assessed using EMG relative to changes in questionnaire scores
Time Frame
6 weeks
Title
Prior to treatment, rotator cuff voluntary activation in patients relative to healthy controls
Description
Assessed using voluntary activation
Time Frame
6 weeks
Title
Prior to treatment, rotator cuff muscle activation in patients relative to healthy controls
Description
Assessed using EMG
Time Frame
6 weeks
Title
After both a subacromial injection and a six-week exercise program, differences in rotator cuff voluntary activation between patients and healthy controls
Description
Assessed using voluntary activation
Time Frame
6 weeks
Title
After both a subacromial injection and a six-week exercise program, differences in rotator cuff muscle activation between patients and healthy controls
Description
Assessed using EMG
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew R Karduna, PhD
Organizational Affiliation
University of Oregon
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oregon
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy

We'll reach out to this number within 24 hrs