Effects of a Scapular-focused Exercise Protocol

Rotator Cuff Syndrome of Shoulder and Allied Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05516186
• Other study ID #: 18/2022 ESSAlcoitão
• Status: Completed
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: July 25, 2022

Study information

• Verified date: August 2022
• Source: NOVA School of Science and Technology i FCT NOVA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 25, 2022
• Est. primary completion date: May 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Syndrome of Shoulder and Allied Disorders
• Syndrome

Intervention

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
• Control Therapy
manual and exercise therapy
• Scapular-focused exercise protocol without EMGBF
Scapular-focused exercises, based on the dos Santos et al (2021) protocol

Locations

Country	Name	City	State
Portugal	Policlínica de Sátão	Viseu

Sponsors (1)

Lead Sponsor	Collaborator
NOVA School of Science and Technology i FCT NOVA

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NPRS numeric pain rating scale	From zero (better score) to 10 (worst score)	At the initial assessment
Primary	NPRS numeric pain rating scale	From zero (better score) to 10 (worst score)	At 6 weeks after the treatment protocol (final assessment)
Primary	SPADI shoulder pain and disability index	From zero (better score) to 100 (worst score)	At the initial assessment
Primary	SPADI shoulder pain and disability index	From zero (better score) to 100 (worst score)	At 6 weeks after the treatment protocol (final assessment)
Primary	DASH disabilities of the arm, shoulder and hand	From zero (better score) to 100 (worst score)	At the initial assessment
Primary	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	scapular stabilizer neuromuscular control	Electromyographic Biofeedback (EMGBF) PhysiopluxTM system version 1.06	At the initial assessment
Secondary	scapular stabilizer neuromuscular control	Electromyographic Biofeedback (EMGBF) PhysiopluxTM system version 1.06	At 6 weeks after the treatment protocol (final assessment)
Secondary	scapular stabilizer activation onset	Electromyographic Biofeedback (EMGBF) PhysiopluxTM system version 1.06	At the initial assessment
Secondary	scapular stabilizer activation onset	Electromyographic Biofeedback (EMGBF) PhysiopluxTM system version 1.06	At 6 weeks after the treatment protocol (final assessment)
Secondary	dynamic scapular alignment	Observation of the medial and the inferior prominences of the scapula	At the initial assessment
Secondary	dynamic scapular alignment	Observation of the medial and the inferior prominences of the scapula	At 6 weeks after the treatment protocol (final assessment)
Secondary	range of motion	Goniometry	At the initial assessment
Secondary	range of motion	Goniometry	At 6 weeks after the treatment protocol (final assessment)
Secondary	glenohumeral flexor and abductor muscle strength	Manual Testing From 0 (worst) to 5 (normal)	At the initial assessment
Secondary	glenohumeral flexor and abductor muscle strength	Manual Testing From 0 (worst) to 5 (normal)	At 6 weeks after the treatment protocol (final assessment)