Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy

NCT02971072 | Completed

• 2 other identifiers: 05022014.0051R01AR063713-01A1
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Rotator cuff voluntary activation after subacromial injection

  2 hours

• Rotator cuff muscle activation after subacromial injection

  2 hours

• Rotator cuff voluntary activation correlations with pain levels

  2 hours

• Rotator cuff activation correlations with pain levels

  2 hours

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

  6 weeks

Study Arms (1)

Patients

EXPERIMENTAL

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

Procedure: Subacromial injection; Other: Physical Therapy

Interventions

Subacromial injection PROCEDURE

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

Patients

Physical Therapy OTHER

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

Patients

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• no current or previous shoulder injury
• matched for age (within 5 years) and sex
• pain with active arm elevation
• positive Hawkins, Neer, or Jobe's test

Sponsors & Collaborators

• University of Oregon: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Oregon

Eugene, Oregon, 97403, United States

Location

MeSH Terms

Conditions

Acute Pain; Atrophy; Wounds and Injuries; Muscle Weakness; Pain; Shoulder Pain; Syndrome; Tendinopathy; Motor Activity; Patient Acceptance of Health Care

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Nervous System Diseases; Pathologic Processes; Arthralgia; Joint Diseases; Disease; Tendon Injuries; Behavior; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Andrew R Karduna, PhD

  University of Oregon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: November 22, 2016
• Study Start: July 1, 2014
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: September 13, 2022

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)