Effects of a Scapular-focused Exercise Protocol

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

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Syndrome of Shoulder and Allied Disorders
• Intervention / Treatment: Other: Control Therapy; Other: Scapular-focused exercise protocol without EMGBF; Other: Scapular-focused exercise protocol with EMGBF

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Viseu, Portugal, 3500
    • Policlínica de Sátão

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1- age between 18 and 60 years; 2 - primary complaint of shoulder pain 3 - RCS clinical diagnosis

Exclusion Criteria:

1. - neurological symptoms;
2. - positive thoracic outlet syndrome (screened with Allen's and Adson's tests);
3. - history of shoulder surgery or fracture;
4. - structural injuries confirmed by imaging (e.g. ligaments and labrum);
5. - symptoms reproduced by cervical examination;
6. - unable to commit to scheduled treatments;
7. - Anti-inflammatory drug use

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Scapular-focused exercise protocol supported by real-time EMGBF; 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; manual and exercise therapy; Other: Scapular-focused exercise protocol without EMGBF; Scapular-focused exercises, based on the dos Santos et al (2021) protocol
Experimental: Scapular-focused exercise protocol without EMGBF; The same protocol described above was applied without EMGBF	Other: Control Therapy; manual and exercise therapy; Other: Scapular-focused exercise protocol with EMGBF; Scapular-focused exercises, based on the dos Santos et al (2021) protocol with the aid of the electromyographic biofeedback
Other: Control therapy group; The control therapy group underwent conservative physical therapy, which included both manual and exercise therapy	Other: Scapular-focused exercise protocol without EMGBF; Scapular-focused exercises, based on the dos Santos et al (2021) protocol; Other: Scapular-focused exercise protocol with EMGBF; Scapular-focused exercises, based on the dos Santos et al (2021) protocol with the aid of the electromyographic biofeedback

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: NOVA School of Science and Technology ı FCT NOVA
• Investigators: Study Chair: Isabel Almeida, MsC, Superior School of Health os Setúbal

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Actual): May 9, 2022
• Study Completion (Actual): July 25, 2022

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: scapular dyskinesis; electromyographic biofeedback; scapula neuromuscular activity and control; rotator cuff related pain syndrome; control therapy; pain and function
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: 18/2022 ESSAlcoitão

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