Rotator Cuff Syndrome of Shoulder and Allied DisordersNCT05516186
Effects of a Scapular-focused Exercise Protocol
A study testing Scapular-focused exercise protocol with EMGBF and Scapular-focused exercise protocol without EMGBF in people with Rotator Cuff Syndrome of Shoulder and Allied Disorders, run by NOVA School of Science and Technology ı FCT NOVA at 1 site in Portugal.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rotator Cuff Syndrome of Shoulder and Allied Disorders
- What is being tested?
- Scapular-focused exercise protocol with EMGBF and Scapular-focused exercise protocol without EMGBF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 9 May 2022to 25 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1- age between 18 and 60 years; 2 - primary complaint of shoulder pain 3 - RCS clinical diagnosis
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Scapular-focused Exercise Protocol for Patients With Rotator Cuff Related Pain Syndrome - a Randomized Clinical Trial
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.
Read the 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.
- Being tested
- Scapular-focused exercise protocol with EMGBF, Control Therapy, Scapular-focused exercise protocol without EMGBF
- Keywords
- scapula neuromuscular activity and control, rotator cuff related pain syndrome, scapular dyskinesis, electromyographic biofeedback, control therapy, pain and function
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scapular-focused exercise protocol with EMGBFOther
Scapular-focused exercises, based on the dos Santos et al (2021) protocol with the aid of the electromyographic biofeedback
Control TherapyOther
manual and exercise therapy
Scapular-focused exercise protocol without EMGBFOther
Scapular-focused exercises, based on the dos Santos et al (2021) protocol
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: Other: Scapular-focused exercise protocol with EMGBF; Other: Scapular-focused exercise protocol without EMGBF |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS numeric pain rating scale
From zero (better score) to 10 (worst score)
Measured: At the initial assessment
NPRS numeric pain rating scale
From zero (better score) to 10 (worst score)
Measured: At 6 weeks after the treatment protocol (final assessment)
SPADI shoulder pain and disability index
From zero (better score) to 100 (worst score)
Measured: At the initial assessment
SPADI shoulder pain and disability index
From zero (better score) to 100 (worst score)
Measured: 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)
Measured: At the initial assessment
DASH disabilities of the arm, shoulder and hand
From zero (better score) to 100 (worst score)
Measured: At 6 weeks after the treatment protocol (final assessment)
Secondary outcomes (10)
scapular stabilizer neuromuscular control
Electromyographic Biofeedback (EMGBF) PhysiopluxTM system version 1.06
Measured: At the initial assessment
scapular stabilizer neuromuscular control
Electromyographic Biofeedback (EMGBF) PhysiopluxTM system version 1.06
Measured: At 6 weeks after the treatment protocol (final assessment)
scapular stabilizer activation onset
Electromyographic Biofeedback (EMGBF) PhysiopluxTM system version 1.06
Measured: At the initial assessment
scapular stabilizer activation onset
Electromyographic Biofeedback (EMGBF) PhysiopluxTM system version 1.06
Measured: At 6 weeks after the treatment protocol (final assessment)
dynamic scapular alignment
Observation of the medial and the inferior prominences of the scapula
Measured: At the initial assessment
dynamic scapular alignment
Observation of the medial and the inferior prominences of the scapula
Measured: At 6 weeks after the treatment protocol (final assessment)
range of motion
Goniometry
Measured: At the initial assessment
range of motion
Goniometry
Measured: At 6 weeks after the treatment protocol (final assessment)
glenohumeral flexor and abductor muscle strength
Manual Testing From 0 (worst) to 5 (normal)
Measured: At the initial assessment
glenohumeral flexor and abductor muscle strength
Manual Testing From 0 (worst) to 5 (normal)
Measured: At 6 weeks after the treatment protocol (final assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start9 May 2022
- Primary completion9 May 2022
- Study completion25 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Syndrome of Shoulder and Allied DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- NOVA School of Science and Technology ı FCT NOVA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Matias, NOVA School of Science and Technology ı FCT NOVA
- Investigators
- Isabel Almeida, MsC, Study chair, Superior School of Health os Setúbal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516186
- Sponsor's protocol ID
- 18/2022 ESSAlcoitão
- Status last verified
- Aug 2022
- First submitted
- 11 Aug 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Scapular-focused Exercise Protocol for Patients With Rotator Cuff Related Pain Syndrome - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05516186
- Acronym / sponsor ID
- 18/2022 ESSAlcoitão
- Keywords
- scapula neuromuscular activity and control, rotator cuff related pain syndrome, scapular dyskinesis, electromyographic biofeedback, control therapy, pain and function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- NOVA School of Science and Technology ı FCT NOVAUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 9 May 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Scapular-focused exercise protocol supported by real-time EMGBF | Experimental | Other: Control Therapy, Other: Scapular-focused exercise protocol without EMGBFThe 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. |
| Scapular-focused exercise protocol without EMGBF | Experimental | Other: Scapular-focused exercise protocol with EMGBF, Other: Control TherapyThe same protocol described above was applied without EMGBF |
| Control therapy group | Other | Other: Scapular-focused exercise protocol with EMGBF, Other: Scapular-focused exercise protocol without EMGBFThe control therapy group underwent conservative physical therapy, which included both manual and exercise therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1- age between 18 and 60 years; 2 - primary complaint of shoulder pain 3 - RCS clinical diagnosis
Key exclusion criteria (7 listed)
- - 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scapular-focused exercise protocol with EMGBFScapular-focused exercises, based on the dos Santos et al (2021) protocol with the aid of the electromyographic biofeedback | Other | Control therapy group, Scapular-focused exercise protocol without EMGBF |
| Control Therapymanual and exercise therapy | Other | Scapular-focused exercise protocol supported by real-time EMGBF, Scapular-focused exercise protocol without EMGBF |
| Scapular-focused exercise protocol without EMGBFScapular-focused exercises, based on the dos Santos et al (2021) protocol | Other | Control therapy group, Scapular-focused exercise protocol supported by real-time EMGBF |
Primary outcome
NPRS numeric pain rating scale
Time frame: At the initial assessment
From zero (better score) to 10 (worst score)
NPRS numeric pain rating scale
Time frame: At 6 weeks after the treatment protocol (final assessment)
From zero (better score) to 10 (worst score)
SPADI shoulder pain and disability index
Time frame: At the initial assessment
From zero (better score) to 100 (worst score)
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)
DASH disabilities of the arm, shoulder and hand
Time frame: At the initial assessment
From zero (better score) to 100 (worst score)
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)
10 secondary outcomes
scapular stabilizer neuromuscular control
Time frame: At the initial assessment
scapular stabilizer neuromuscular control
Time frame: At 6 weeks after the treatment protocol (final assessment)
scapular stabilizer activation onset
Time frame: At the initial assessment
scapular stabilizer activation onset
Time frame: At 6 weeks after the treatment protocol (final assessment)
dynamic scapular alignment
Time frame: At the initial assessment
dynamic scapular alignment
Time frame: At 6 weeks after the treatment protocol (final assessment)
range of motion
Time frame: At the initial assessment
range of motion
Time frame: At 6 weeks after the treatment protocol (final assessment)
glenohumeral flexor and abductor muscle strength
Time frame: At the initial assessment
glenohumeral flexor and abductor muscle strength
Time frame: At 6 weeks after the treatment protocol (final assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabel Almeida, MsC study chair
Superior School of Health os Setúbal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scapular-focused exercise protocol with EMGBF and Scapular-focused exercise protocol without EMGBF in people with Rotator Cuff Syndrome of Shoulder and Allied Disorders, run by NOVA School of Science and Technology ı FCT NOVA at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NPRS numeric pain rating scale (time frame: At the initial assessment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022; AzTrials last refreshed its copy on 29 Oct 2026.