Clinical trial NCT05516186: Effects of a Scapular-focused Exercise Protocol
Official title: Effects of a Scapular-focused Exercise Protocol for Patients With Rotator Cuff Related Pain Syndrome - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: NOVA School of Science and Technology ı FCT NOVA
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: NPRS numeric pain rating scale
timeFrame: At the initial assessment
measure: NPRS numeric pain rating scale
timeFrame: At 6 weeks after the treatment protocol (final assessment)
measure: SPADI shoulder pain and disability index
timeFrame: At the initial assessment
measure: SPADI shoulder pain and disability index
timeFrame: At 6 weeks after the treatment protocol (final assessment)
measure: DASH disabilities of the arm, shoulder and hand
timeFrame: At the initial assessment
measure: DASH disabilities of the arm, shoulder and hand
timeFrame: At 6 weeks after the treatment protocol (final assessment)
Secondary outcomes:
measure: scapular stabilizer neuromuscular control
timeFrame: At the initial assessment
measure: scapular stabilizer neuromuscular control
timeFrame: At 6 weeks after the treatment protocol (final assessment)
measure: scapular stabilizer activation onset
timeFrame: At the initial assessment
measure: scapular stabilizer activation onset
timeFrame: At 6 weeks after the treatment protocol (final assessment)
measure: dynamic scapular alignment
timeFrame: At the initial assessment
measure: dynamic scapular alignment
timeFrame: At 6 weeks after the treatment protocol (final assessment)
measure: range of motion
timeFrame: At the initial assessment
measure: range of motion
timeFrame: At 6 weeks after the treatment protocol (final assessment)
measure: glenohumeral flexor and abductor muscle strength
timeFrame: At the initial assessment
measure: glenohumeral flexor and abductor muscle strength
timeFrame: At 6 weeks after the treatment protocol (final assessment)
Other outcomes:
Locations:
city: Viseu
country: Portugal
facility: Policlínica de Sátão
Study officials:
affiliation: Superior School of Health os Setúbal
name: Isabel Almeida, MsC
role: STUDY_CHAIR
References: