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.

Study Overview

• Status: Completed
• Conditions: Syndrome; Pain; Muscle Weakness; Tendinopathy; Shoulder Pain; Acute Pain; Impairment; Goals; Pathology; Injury; Infiltration; Atrophic
• Intervention / Treatment: Procedure: Subacromial injection; Other: Physical Therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97403
      • University of Oregon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients; Subjects with shoulder tendinopathy who will undergo both a subacromial injection and physical therapy	Procedure: Subacromial injection; A subacromial injection consisting up 6 cc 0.5% Marcaine with Epinephrine and 1 cc DepoMedrol will be administered.; Other: Physical Therapy; A standardized six-week exercise protocol supervised by a physical therapist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rotator cuff activation after subacromial injection and exercise intervention, difference in rotator cuff voluntary activation between subjects and controls	Assessed using voluntary activation	6 weeks
Rotator cuff activation after subacromial injection and exercise intervention, difference in specific rotator cuff muscle activation between subjects and controls	Assessed using electromyography (EMG)	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rotator cuff voluntary activation after subacromial injection	Assessed using voluntary activation	2 hours
Rotator cuff muscle activation after subacromial injection	Assessed using EMG	2 hours
Rotator cuff voluntary activation correlations with pain levels	Assessed using voluntary activation relative to self-reported pain level	2 hours
Rotator cuff activation correlations with pain levels	Assessed using EMG relative to self-reported pain level	2 hours
Rotator cuff voluntary activation after 6-week exercise intervention and subacromial injection	Assessed using voluntary activation	6 weeks
Rotator cuff muscle activation after 6-week exercise intervention and subacromial injection	Assessed using EMG	6 weeks
Rotator cuff voluntary activation correlation with improvements in pain relief	Assessed using voluntary activation relative to self-reported pain relief	6 weeks
Rotator cuff voluntary activation correlation with improvements in clinical outcome measures	Assessed using voluntary activation relative to changes in questionnaire scores	6 weeks
Rotator cuff muscle activation correlation with improvements in pain relief	Assessed using EMG relative to self-reported pain relief	6 weeks
Rotator cuff muscle activation correlation with improvements in clinical outcome measures	Assessed using EMG relative to changes in questionnaire scores	6 weeks
Prior to treatment, rotator cuff voluntary activation in patients relative to healthy controls	Assessed using voluntary activation	6 weeks
Prior to treatment, rotator cuff muscle activation in patients relative to healthy controls	Assessed using EMG	6 weeks
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	6 weeks
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	6 weeks

Collaborators and Investigators

• Sponsor: University of Oregon
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Andrew R Karduna, PhD, University of Oregon

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: November 17, 2016
• First Posted (Estimate): November 22, 2016

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 7, 2022
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: biofeedback; exercise; patients; strength training; outcome; electrical stimulation; effectiveness; muscle; intervention; training; electromyography; systematic review; disability; staging; motor control; knowledge; shoulder; motor; testing; clinical; techniques; work; attention; cost; rotator cuff; neurophysiology; time; research; United States; exertion; modeling; success; local anesthetics; treatment strategy; innovation; atrophic; outcome measure; base; improved; programs; measures; public health relevance; data; pattern; health care service utilization; address; injection of therapeutic agent; neuroadaptation; novel; pain inhibition; rehabilitation strategy; relating to nervous system; reporting
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Arthralgia; Muscle Weakness; Tendinopathy; Shoulder Pain; Acute Pain; Atrophy; Asthenia
• Other Study ID Numbers: 05022014.005; 1R01AR063713-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO