Effects of a Scapular-focused Exercise Protocol

NCT05516186 | Completed

• 1 other identifier: 18/2022 ESSAlcoitão
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Syndrome of Shoulder and Allied Disorders

Keywords

scapula neuromuscular activity and control; rotator cuff related pain syndrome; scapular dyskinesis; electromyographic biofeedback; control therapy; pain and function

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (10)

• scapular stabilizer neuromuscular control

  At the initial assessment

• scapular stabilizer neuromuscular control

  At 6 weeks after the treatment protocol (final assessment)

• scapular stabilizer activation onset

  At the initial assessment

• scapular stabilizer activation onset

  At 6 weeks after the treatment protocol (final assessment)

• dynamic scapular alignment

  At the initial assessment

Study Arms (3)

Scapular-focused exercise protocol supported by real-time EMGBF

EXPERIMENTAL

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; Other: Scapular-focused exercise protocol without EMGBF

Scapular-focused exercise protocol without EMGBF

EXPERIMENTAL

The same protocol described above was applied without EMGBF

Other: Scapular-focused exercise protocol with EMGBF; Other: Control Therapy

Control therapy group

OTHER

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

Other: Scapular-focused exercise protocol with EMGBF; Other: Scapular-focused exercise protocol without EMGBF

Interventions

Scapular-focused exercise protocol with EMGBF OTHER

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

Control therapy group; Scapular-focused exercise protocol without EMGBF

Control Therapy OTHER

manual and exercise therapy

Scapular-focused exercise protocol supported by real-time EMGBF; Scapular-focused exercise protocol without EMGBF

Scapular-focused exercise protocol without EMGBF OTHER

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

Control therapy group; Scapular-focused exercise protocol supported by real-time EMGBF

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• NOVA School of Science and Technology ı FCT NOVA: lead

Study Sites (1)

Policlínica de Sátão

Viseu, 3500, Portugal

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Isabel Almeida, MsC

  Superior School of Health os Setúbal

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 25, 2022
• Study Start: May 9, 2022
• Primary Completion: May 9, 2022
• Study Completion: July 25, 2022
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)