Pain Neuroscience Education Plus Exercise Versus Exercise Alone in the Management of Chronic Rotator Cuff Tendinopathy: a Randomized Controlled Trial

Ruben Fernandez Matias1 site in 1 country52 target enrollmentJuly 25, 2021

ConditionsRotator Cuff Tendinosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rotator Cuff Tendinosis
Sponsor: Ruben Fernandez Matias
Enrollment: 52
Locations: 1
Primary Endpoint: Change in pain intensity
Status: Suspended
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this randomized controlled trial is to evaluate the combined effects of pain neuroscience education plus exercise to exercise alone in the management of patients with chronic rotator cuff tendinopathy regarding pain, function, strength, kinesiophobia, and pain catastrophizing.

Registry

clinicaltrials.gov

Start Date

July 25, 2021

End Date

October 1, 2029

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ruben Fernandez Matias

Responsible Party

Sponsor Investigator

Principal Investigator

Ruben Fernandez Matias

Clinical Professor

University of Alcala

Eligibility Criteria

Inclusion Criteria

•Shoulder pain due to rotator cuff tendinopathy lasting more than 6 months.
•Internal Rotation Resisted Strength Test positive.
•Test Item Cluster (Hawkins-Kennedy, painful arc, and infraspinatus test) positive.

Exclusion Criteria

•History of: tumors, metastasis, osteoporosis, shoulder fractures, shoulder luxation and/or instability, previous shoulder surgery, cervical radiculopathy, full-thickness rotator cuff tears, glenohumeral joint degeneration, inflammatory arthropathy, acromioclavicular joint arthrosis, and rotator cuff calcifications.
•Being treated by other physical therapy or medical treatment for their shoulder pain at the time of recruitment.

Outcomes

Primary Outcomes

Change in pain intensity

Time Frame: Baseline, change from baseline at 4-week, and change from baseline at 12-week

Pain intensity measured with numerical pain rating scale which ranges from 0 points (no pain) to 10 points (worst imaginable pain)

Secondary Outcomes

Catastrophism change(Baseline, change from baseline at 4-week, and change from baseline at 12-week)
Shoulder disability change(Baseline, change from baseline at 4-week, and change from baseline at 12-week)
Kinesiophobia change(Baseline, change from baseline at 4-week, and change from baseline at 12-week)
Strength change(Baseline, change from baseline at 4-week, and change from baseline at 12-week)