Effects of a Scapular-focused Exercise Protocol

Not Applicable

Completed

• Conditions: Rotator Cuff Syndrome of Shoulder and Allied Disorders

• Registration Number: NCT05516186
• Lead Sponsor: NOVA School of Science and Technology ı FCT NOVA

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.

Study Timeline

• Study Start: 2022-05-09
• Primary Completion: 2022-05-09
• Study Completion: 2022-07-25
• Status Verified: 2022-08
• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-23
• Last Update Submitted: 2022-08-23
• Study First Posted: 2022-08-25
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
NPRS numeric pain rating scale	At 6 weeks after the treatment protocol (final assessment)	From zero (better score) to 10 (worst score)
SPADI shoulder pain and disability index	At 6 weeks after the treatment protocol (final assessment)	From zero (better score) to 100 (worst score)
DASH disabilities of the arm, shoulder and hand	At 6 weeks after the treatment protocol (final assessment)	From zero (better score) to 100 (worst score)

Secondary Outcome Measures

Name	Time	Method
dynamic scapular alignment	At 6 weeks after the treatment protocol (final assessment)	Observation of the medial and the inferior prominences of the scapula
range of motion	At 6 weeks after the treatment protocol (final assessment)	Goniometry
scapular stabilizer activation onset	At 6 weeks after the treatment protocol (final assessment)	Electromyographic Biofeedback (EMGBF) PhysiopluxTM system version 1.06
scapular stabilizer neuromuscular control	At 6 weeks after the treatment protocol (final assessment)	Electromyographic Biofeedback (EMGBF) PhysiopluxTM system version 1.06
glenohumeral flexor and abductor muscle strength	At 6 weeks after the treatment protocol (final assessment)	Manual Testing From 0 (worst) to 5 (normal)

Trial Locations

Locations (1)

Policlínica de Sátão; 🇵🇹 Viseu, Portugal