PNE Plus Exercise Versus Exercise for Chronic Rotator Cuff Tendinopathy

Study Overview
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Brief Summary
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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.

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

Conditions
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Rotator Cuff Tendinosis

Intervention / Treatment
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* Other: Pain neuroscience education
* Other: Exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain neuroscience education plus exercise<br>Three sessions of pain neuroscience education plus exercise. | Other: Pain neuroscience education<br>* 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.<br>Other: Exercise<br>* Progressive resistance exercise program based on isometric, concentric, eccentric, and pliometric contractions.<br>|
| Active Comparator: Exercise alone<br>Exercise alone without pain neuroscience education. | Other: Exercise<br>* Progressive resistance exercise program based on isometric, concentric, eccentric, and pliometric contractions.<br>|

What is the study measuring?
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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 |