Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy

Sponsor

University of Oregon (Other)

Overall Status

Unknown status

CT.gov ID

NCT02971072

Collaborator

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

180

Enrollment

Location

Arm

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Pain Atrophic Goals Impairment Infiltration Injury Muscle Weakness Pain Pathology Shoulder Pain Syndrome Tendinopathy	Procedure: Subacromial injection Other: Physical Therapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy

Actual Study Start Date :

Jul 1, 2014

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Rotator cuff activation after subacromial injection and exercise intervention, difference in rotator cuff voluntary activation between subjects and controls [6 weeks]
Assessed using voluntary activation
Rotator cuff activation after subacromial injection and exercise intervention, difference in specific rotator cuff muscle activation between subjects and controls [6 weeks]
Assessed using electromyography (EMG)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)