Effects of a Scapular-focused Exercise Protocol

NCT ID: NCT05516186

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-09
• Study Completion Date: 2022-07-25

Brief 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.

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.

Conditions

Rotator Cuff Syndrome of Shoulder and Allied Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Control Therapy

Intervention Type: OTHER

manual and exercise therapy

Scapular-focused exercise protocol without EMGBF

Intervention Type: OTHER

Scapular-focused exercises, based on the dos Santos et al (2021) protocol

Scapular-focused exercise protocol without EMGBF

The same protocol described above was applied without EMGBF

Group Type: EXPERIMENTAL

Scapular-focused exercise protocol with EMGBF

Intervention Type: OTHER

Scapular-focused exercises, based on the dos Santos et al (2021) protocol with the aid of the electromyographic biofeedback

Control Therapy

Intervention Type: OTHER

manual and exercise therapy

Control therapy group

The control therapy group underwent conservative physical therapy, which included both manual and exercise therapy

Group Type: OTHER

Scapular-focused exercise protocol with EMGBF

Intervention Type: OTHER

Scapular-focused exercises, based on the dos Santos et al (2021) protocol with the aid of the electromyographic biofeedback

Scapular-focused exercise protocol without EMGBF

Intervention Type: OTHER

Scapular-focused exercises, based on the dos Santos et al (2021) protocol

Interventions

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

Intervention Type: OTHER

Control Therapy

manual and exercise therapy

Intervention Type: OTHER

Scapular-focused exercise protocol without EMGBF

Scapular-focused exercises, based on the dos Santos et al (2021) protocol

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NOVA School of Science and Technology ı FCT NOVA

OTHER

Sponsor Role: lead

Responsible Party

Ricardo Matias

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Isabel Almeida, MsC

Role: STUDY_CHAIR

Superior School of Health os Setúbal

Locations

Policlínica de Sátão

Viseu, , Portugal

Countries

Portugal

Other Identifiers

18/2022 ESSAlcoitão

Identifier Type: -

Identifier Source: org_study_id