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Completed

NCT Number: NCT05516186

Effects of a Scapular-focused Exercise Protocol

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.

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Key information

Conditions

Rotator Cuff Syndrome of Shoulder and Allied Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlínica de Sátão

Viseu, 3500, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

manual and exercise therapy

Scapular-focused exercise protocol without EMGBF

Other

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

Primary outcomes

  1. NPRS numeric pain rating scale

    Time frame: At the initial assessment

    From zero (better score) to 10 (worst score)

  2. NPRS numeric pain rating scale

    Time frame: At 6 weeks after the treatment protocol (final assessment)

    From zero (better score) to 10 (worst score)

  3. SPADI shoulder pain and disability index

    Time frame: At the initial assessment

    From zero (better score) to 100 (worst score)

  4. SPADI shoulder pain and disability index

    Time frame: At 6 weeks after the treatment protocol (final assessment)

    From zero (better score) to 100 (worst score)

  5. DASH disabilities of the arm, shoulder and hand

    Time frame: At the initial assessment

    From zero (better score) to 100 (worst score)

  6. DASH disabilities of the arm, shoulder and hand

    Time frame: At 6 weeks after the treatment protocol (final assessment)

    From zero (better score) to 100 (worst score)

Secondary outcomes

  1. scapular stabilizer neuromuscular control

    Time frame: At the initial assessment

    Electromyographic Biofeedback (EMGBF) PhysiopluxTM system version 1.06

  2. scapular stabilizer neuromuscular control

    Time frame: At 6 weeks after the treatment protocol (final assessment)

    Electromyographic Biofeedback (EMGBF) PhysiopluxTM system version 1.06

  3. scapular stabilizer activation onset

    Time frame: At the initial assessment

    Electromyographic Biofeedback (EMGBF) PhysiopluxTM system version 1.06

  4. scapular stabilizer activation onset

    Time frame: At 6 weeks after the treatment protocol (final assessment)

    Electromyographic Biofeedback (EMGBF) PhysiopluxTM system version 1.06

  5. dynamic scapular alignment

    Time frame: At the initial assessment

    Observation of the medial and the inferior prominences of the scapula

  6. dynamic scapular alignment

    Time frame: At 6 weeks after the treatment protocol (final assessment)

    Observation of the medial and the inferior prominences of the scapula

  7. range of motion

    Time frame: At the initial assessment

    Goniometry

  8. range of motion

    Time frame: At 6 weeks after the treatment protocol (final assessment)

    Goniometry

  9. glenohumeral flexor and abductor muscle strength

    Time frame: At the initial assessment

    Manual Testing From 0 (worst) to 5 (normal)

  10. glenohumeral flexor and abductor muscle strength

    Time frame: At 6 weeks after the treatment protocol (final assessment)

    Manual Testing From 0 (worst) to 5 (normal)

Sponsors and collaborators

Lead sponsor

NOVA School of Science and Technology ı FCT NOVA

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 25, 2022
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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