PNE Plus Exercise Versus Exercise for Chronic Rotator Cuff Tendinopathy

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

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.

Study Overview

• Status: Suspended
• Conditions: Rotator Cuff Tendinosis
• Intervention / Treatment: Other: Pain neuroscience education; Other: Exercise

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcalá De Henares, Madrid, Spain, 28805
      • Rubén Fernández-Matías

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pain neuroscience education plus exercise; Three sessions of pain neuroscience education plus exercise.	Other: Pain neuroscience education; Three sessions of pain neuroscience education based on explaining patients: characteristics of acute versus chronic pain, function of acute pain, how acute pain is originated within the nervous system, how acute pain progress to chronic pain, and factors that contribute to central sensitization (e.g., emotions, stress, disease and pain beliefs, behaviors regarding pain...). All the explanations will be conducted using easy-understandable examples and metaphors.; Other: Exercise; Progressive resistance exercise program based on isometric, concentric, eccentric, and pliometric contractions.
Active Comparator: Exercise alone; Exercise alone without pain neuroscience education.	Other: Exercise; Progressive resistance exercise program based on isometric, concentric, eccentric, and pliometric contractions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain intensity	Pain intensity measured with numerical pain rating scale which ranges from 0 points (no pain) to 10 points (worst imaginable pain)	Baseline, change from baseline at 4-week, and change from baseline at 12-week

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ruben Fernandez Matias

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2021
• Primary Completion (Actual): October 1, 2021
• Study Completion (Anticipated): October 1, 2029

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): August 2, 2021

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Tendinopathy
• Other Study ID Numbers: 2020/58

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No