PNE Plus Exercise Versus Exercise for Chronic Rotator Cuff Tendinopathy

Not Applicable

Suspended

• Conditions: Rotator Cuff Tendinosis
• Interventions: Other: Pain neuroscience education; Other: Exercise

• Registration Number: NCT04985370
• Lead Sponsor: Ruben Fernandez Matias

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-20
• Study Start: 2021-07-25
• Study First Submitted QC: 2021-07-28
• Study First Posted: 2021-08-02
• Primary Completion: 2021-10-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-17
• Last Update Posted: 2022-11-22
• Study Completion: 2029-10-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pain neuroscience education plus exercise	Exercise	Three sessions of pain neuroscience education plus exercise.
Pain neuroscience education plus exercise	Pain neuroscience education	Three sessions of pain neuroscience education plus exercise.
Exercise alone	Exercise	Exercise alone without pain neuroscience education.

Primary Outcome Measures

Name	Time	Method
Change in pain intensity	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 Outcome Measures

Name	Time	Method
Catastrophism change	Baseline, change from baseline at 4-week, and change from baseline at 12-week	Catastrophism measured with Pain Catastrophizing Scale (PCS) which ranges from 0% (no catastrophism) to 100% (maximum degree of catastrophism).
Shoulder disability change	Baseline, change from baseline at 4-week, and change from baseline at 12-week	Shoulder disability measured with Shoulder Pain and Disability Index (SPADI). SPADI ranges from 0% (no disability) to 100% (maximum degree of disability).
Kinesiophobia change	Baseline, change from baseline at 4-week, and change from baseline at 12-week	Kinesiophobia measured with Tampa Scale for Kinesiophobia (TSK-11) which ranges from 0% (no kinesiophobia) to 100% (maximum degree of kinesiophobia).
Strength change	Baseline, change from baseline at 4-week, and change from baseline at 12-week	Scaption strength at 90º of elevation measured with a hand-held dynamometer

Trial Locations

Locations (1)

Rubén Fernández-Matías; 🇪🇸 Alcalá De Henares, Madrid, Spain