Effects of a Scapular-focused Exercise Protocol

Study Overview
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Brief Summary
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Background: Current clinical practice still lacks consistent evidence in the physiotherapy management of Rotator cuff related pain syndrome (RCS). The purpose of this trial was to compare the effectiveness of a scapular-focused treatment with and without real-time electromyographic biofeedback (EMGBF) to a control therapy in patients with RCS. Methods: 60 patients with RCS were divided into three groups: scapular-focused exercise protocol group (P_G n=20), scapular-focused exercise protocol with EMGBF group (P+EMGBF_G n=20) and control therapy group (CT_G n=20). Values of pain and function [Shoulder Pain and Disability Index (SPADI) questionnaire, complemented by the Numeric Pain Rating Scale (NPRS) and Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire], scapular stabilizer neuromuscular control (SSNC), scapular stabilizer activation onset (SSAO), dynamic scapular alignment, range of motion (ROM) and glenohumeral flexor and abductor muscle strength (GMS) were assessed at baseline and after 6-weeks and compared within and between groups.

Detailed Description
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In order to advance the understanding of the value of scapular-focused exercise for rotator cuff related syndrome, a new trial was designed with the main objective of comparing pain and function outcomes between three different treatment protocols for patients with RCS: P_G - Scapular-focused exercise protocol without electromyographic biofeedback (EMGBF) P+EMGBF_G - Scapular-focused exercise protocol supported by real-time EMGBF CT_G - Control therapy group with manual therapy (glenohumeral joint physiologic and accessory mobilization) , massage to reduce upper trapezius (UT) stiffness, and shoulder rotation strengthening into external rotation Every outcomes was assessed at the beginning of treatment, and then, weekly until completed 6 weeks of treatment.

Official Title
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Effects of a Scapular-focused Exercise Protocol for Patients With Rotator Cuff Related Pain Syndrome - a Randomized Clinical Trial

Conditions
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Rotator Cuff Syndrome of Shoulder and Allied Disorders

Intervention / Treatment
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* Other: Scapular-focused exercise protocol with EMGBF
* Other: Control Therapy
* Other: Scapular-focused exercise protocol without EMGBF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1- age between 18 and 60 years; 2 - primary complaint of shoulder pain 3 - RCS clinical diagnosis Exclusion Criteria: - neurological symptoms; - positive thoracic outlet syndrome (screened with Allen's and Adson's tests); - history of shoulder surgery or fracture; - structural injuries confirmed by imaging (e.g. ligaments and labrum); - symptoms reproduced by cervical examination; - unable to commit to scheduled treatments; - Anti-inflammatory drug use

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Scapular-focused exercise protocol supported by real-time EMGBF<br>The scapular-focused exercise protocol followed the protocol described by dos Santos et al. (2021). The protocol uses sequential stages of motor relearning (cognitive, associative, and autonomous) as a framework, while promoting the integration of local and global muscle function in weekly sessions divided into three phases. The main purpose of the protocol is to increase scapular neuromuscular activity and control. | Other: Control Therapy<br>* manual and exercise therapy<br>Other: Scapular-focused exercise protocol without EMGBF<br>* Scapular-focused exercises, based on the dos Santos et al (2021) protocol<br>|
| Experimental: Scapular-focused exercise protocol without EMGBF<br>The same protocol described above was applied without EMGBF | Other: Scapular-focused exercise protocol with EMGBF<br>* Scapular-focused exercises, based on the dos Santos et al (2021) protocol with the aid of the electromyographic biofeedback<br>Other: Control Therapy<br>* manual and exercise therapy<br>|
| Other: Control therapy group<br>The control therapy group underwent conservative physical therapy, which included both manual and exercise therapy | Other: Scapular-focused exercise protocol with EMGBF<br>* Scapular-focused exercises, based on the dos Santos et al (2021) protocol with the aid of the electromyographic biofeedback<br>Other: Scapular-focused exercise protocol without EMGBF<br>* Scapular-focused exercises, based on the dos Santos et al (2021) protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NPRS numeric pain rating scale | From zero (better score) to 10 (worst score) | At the initial assessment | 
| NPRS numeric pain rating scale | From zero (better score) to 10 (worst score) | At 6 weeks after the treatment protocol (final assessment) | 
| SPADI shoulder pain and disability index | From zero (better score) to 100 (worst score) | At the initial assessment | 
| SPADI shoulder pain and disability index | From zero (better score) to 100 (worst score) | At 6 weeks after the treatment protocol (final assessment) | 
| DASH disabilities of the arm, shoulder and hand | From zero (better score) to 100 (worst score) | At the initial assessment | 
| DASH disabilities of the arm, shoulder and hand | From zero (better score) to 100 (worst score) | At 6 weeks after the treatment protocol (final assessment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scapular stabilizer neuromuscular control | Electromyographic Biofeedback (EMGBF) PhysiopluxTM system version 1.06 | At the initial assessment | 
| scapular stabilizer neuromuscular control | Electromyographic Biofeedback (EMGBF) PhysiopluxTM system version 1.06 | At 6 weeks after the treatment protocol (final assessment) | 
| scapular stabilizer activation onset | Electromyographic Biofeedback (EMGBF) PhysiopluxTM system version 1.06 | At the initial assessment | 
| scapular stabilizer activation onset | Electromyographic Biofeedback (EMGBF) PhysiopluxTM system version 1.06 | At 6 weeks after the treatment protocol (final assessment) | 
| dynamic scapular alignment | Observation of the medial and the inferior prominences of the scapula | At the initial assessment | 
| dynamic scapular alignment | Observation of the medial and the inferior prominences of the scapula | At 6 weeks after the treatment protocol (final assessment) | 
| range of motion | Goniometry | At the initial assessment | 
| range of motion | Goniometry | At 6 weeks after the treatment protocol (final assessment) | 
| glenohumeral flexor and abductor muscle strength | Manual Testing From 0 (worst) to 5 (normal) | At the initial assessment | 
| glenohumeral flexor and abductor muscle strength | Manual Testing From 0 (worst) to 5 (normal) | At 6 weeks after the treatment protocol (final assessment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scapula neuromuscular activity and control, rotator cuff related pain syndrome, scapular dyskinesis, electromyographic biofeedback, control therapy, pain and function