Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy

Pain Clinical Trial

Official title:

Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02971072
• Other study ID #: 05022014.005
• Secondary ID: 1R01AR063713-01A
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: April 2021

Study information

• Verified date: March 2020
• Source: University of Oregon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Asthenia
• Atrophic
• Atrophy
• Goals
• Impairment
• Infiltration
• Injury
• Muscle Weakness
• Pain
• Pathology
• Shoulder Pain
• Syndrome
• Tendinopathy

Intervention

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

Locations

Country	Name	City	State
United States	University of Oregon	Eugene	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
University of Oregon	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

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