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Trial registered on ANZCTR


Registration number
ACTRN12622000191796
Ethics application status
Approved
Date submitted
23/06/2021
Date registered
3/02/2022
Date last updated
3/02/2022
Date data sharing statement initially provided
3/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Segmental Muscle Vibration for Subacromial Impingement Syndrome
Scientific title
Effectiveness of Adding Segmental Muscle Vibration to Conventional Rehabilitation Treatment for Subacromial Impingement Syndrome
Secondary ID [1] 304609 0
N/A
Universal Trial Number (UTN)
U1111-1267-0966
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subacromial Impingement Syndrome 322520 0
Condition category
Condition code
Musculoskeletal 320156 320156 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 320157 320157 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an interventional prospective study. All intervention will be performed by an experienced physiotherapist

Group 1: Conventional rehabilitation treatment plus segmental vibration treatment.

Group 1 will undergo conventional rehabilitation treatment plus segmental vibration energy treatment, 3 times a week for 12 weeks. Each treatment session took 60 minutes, including 10 minutes of segmental vibration treatment and 50 minutes of conventional rehabilitation treatment.
Segmental vibration treatment will administered via a 28 cm transducer connected with the NEMES Bosco System (SterLin CO, Athens, Greece) device, and will include three sets of 30 seconds each of segmental vibration, at a frequency of 25 Hz. Each patient will be required to strongly hold the vibrating transducer in 3 positions: 1) upper limb in adduction position (arm at the side), with a 3 kg band around the wrist to distract the arm; 2) Starting position: 90° abduction. The patient will be required to adduct in a frontal plane against a fixed resistance while holding the transducer (humeral head depression); 3) Upper limb at the side, elbow at 90° of flexion, the patient will be required to externally rotate against a fixed resistance, without activating deltoid muscle , while holding the transducer.
The conventional rehabilitation treatment will consist of active Range of Motion exercises, stretching and strengthening exercises.
Range of Motion exercises will include shoulder retraction (athletes will actively perform external rotation of the shoulder while keeping elbow in a flexed position), pendulum exercise (participants will perform swinging movement of the shoulder joint in a clockwise and counterclockwise direction), active training of scapula muscle (participants will perform scapular pullbacks keeping arms at their sides), active-assisted exercises with the cane (participants will perform medial and lateral rotations, flexion and diagonal elevation by holding a cane with both hands and applying force mainly from the normal side) and posture exercises (participants will be taught to self-correct their abnormal shoulder excursion while performing active shoulder elevation in front of a mirror). Participants will also be instructed to perform stretching of the anterior shoulder (participants will placing their forearms and hand on the wall, stand at an arm’s length and then lean forward) and posterior shoulder capsule (participants will stand against the wall and while anchoring the affected side scapula they will bring the affected shoulder into cross-body adduction in such a way that the stretch will be felt in the back of the shoulder).
Strengthening exercises will include internal and external rotations (i.e., infraspinatus, teres minor, and subscapularis) performed using TheraBand and ShoulderRX device, and Scapular stabilization exercises (i.e. rhomboids, lower trapezius, serratus anterior and latissimus dorsi) performed using TheraBand. The progression pattern of the strengthening exercises comprised graduating the repetition counts from starting 2 sets of 10 reps to 3 sets of 10 reps.
Treatment were administered face-to-face by experienced physiotherapists. During each session, the patients were observed for substitution or compensatory movements and corrected when required.
Since the intervention is face to face, the patient's adherence to treatment will be recorded directly by the physiotherapist for each patient in each session
Intervention code [1] 320959 0
Treatment: Other
Comparator / control treatment
Group 2: Conventional rehabilitation treatment alone.

The comparator treatment will be the only conventional rehabilitation treatment without the segmental vibration program, and will be administered to Group 2 in the same way as Group 1
.
Control group
Active

Outcomes
Primary outcome [1] 328034 0
The simple shoulder test (SST). The SST consists of 12 questions with yes (1) or no (0) response options. The maximum SST score is 12 indicating normal shoulder function, minimum score of 0 points refers severely diminished shoulder function. The SST has good reliability and responsiveness in patients with RC symptoms. The MCID for the SST in RC disease is 2 points for the range 0–12 or 17 points for the range 0-100. The italian version of the SST will be used in this study.
Timepoint [1] 328034 0
baseline and at the end of treatment (12 weeks post-intervention commencement)
Secondary outcome [1] 397300 0
Visual Analogue Scale (VAS)
We used a VAS scale (0-100 mm) to measure the patient’s perceived pain intensity at rest and at arm activity during the 24 hours preceding the assessment. Shoulder pain was assessed on a 100 mm scale ranging from 0 (no pain) to 100 (extreme pain). We considered 15 as the minimal clinically important difference (MCID) for VAS.
Timepoint [1] 397300 0
Baseline and after the end of treatment (12 weeks post-intervention commencement)
Secondary outcome [2] 397301 0
Range of motion (ROM)

Shoulder active abduction Range Of Motion was measured in degrees using a digital inclinometer and assessed in the scapular plane with the arm in an intermediate plane between pure shoulder flexion and abduction and the hand pronated.
Timepoint [2] 397301 0
Baseline and after the end of treatment (12 weeks post-intervention commencement)
Secondary outcome [3] 397307 0
Range of motion (ROM)

Shoulder active flexion Range of motion was measured in degrees using a digital inclinometer and assessed in the sagittal plane, with the arm at the side and the hand in neutral position
Timepoint [3] 397307 0
Baseline and after the end of treatment (12 weeks post-intervention commencement)
Secondary outcome [4] 402209 0
Range of motion (ROM)

Shoulder active internal rotation was measured in degrees using a digital inclinometer and assessed in the transverse plane, with the arm in 90° of abduction, the elbow at 90° of flexion, hand in neutral position and forearm perpendicular to floor.
Timepoint [4] 402209 0
Baseline and after the end of treatment (12 weeks post-intervention commencement)
Secondary outcome [5] 402210 0
Range of motion (ROM)

Shoulder active external rotation was measured in degrees using a digital inclinometer and assessed in the transverse plane, with the arm in 90° of abduction, the elbow at 90° of flexion, hand in neutral position and forearm perpendicular to floor.
Timepoint [5] 402210 0
Baseline and after the end of treatment (12 weeks post-intervention commencement)
Secondary outcome [6] 402211 0
Maximum isometric voluntary contraction (MVCi)

MVCi will be assessed for abduction by an handheld dynamometer with torque expressed in Newton meter per kilo body weight, (Nm/kg).
Timepoint [6] 402211 0
Baseline and after the end of treatment (12 weeks post-intervention commencement)
Secondary outcome [7] 402212 0
Maximum isometric voluntary contraction (MVCi)

MVCi will be assessed for external rotation by an handheld dynamometer with torque expressed in Newton meter per kilo body weight, (Nm/kg).
Timepoint [7] 402212 0
Baseline and after the end of treatment (12 weeks post-intervention commencement)

Eligibility
Key inclusion criteria
Subjects older than 18 years.
Subjects previously diagnosed with shoulder impingement syndrome.
Positive result in 3 of the 5 following diagnostic tests: .Hawkins-Kennedy test, Neer’s test, pain-full arc, Patte's manoeuvre.and Jobe’s test
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any known malignancies, inflammatory diseases, infectious diseases or neurological diseases of the shoulder;previous fracture of the shoulder; Any surgeries of the shoulder; Xray verified glenohumeral osteoarthritis; Rotator cuff rupture; history of frozen shoulder; shoulder instability and/ labral lesions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients agreeing to participate in this study were randomly allocated into study and control groups with a computerbased 1 a :1 randomization scheme and sealed envelopes
prepared by an assistant researcher at the University of L’Aquila, who was independent of
the recruitment process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We elected to use randomized blocks with equal size using “Random Allocation Software” (Version 1.0, May 2004; Department of Anesthesia, Isfahan University of Medical Sciences, Isfahan, Iran) for parallel-group trials.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculation will be based on the primary outcome measure of SST. To detect a minimal clinically important improvement (MCII) in the SST score (improvement of at least 17 points) assuming a SD of 15 points between the two groups, with a two-sided type I error of 0,05 and a type II error of 80%, and assuming a 15% of patients drop-out, our study will require 15 patients for each group.
A two-sample unpaired t test and chi-square test will be applied to compare the differences of continuous and categorical variables, respectively.
A two-way analysis of variance (ANOVA) with group (conventional rehabilitation program versus conventional rehabilitation program plus segmental muscle vibration) as the between-subject factor and time (before and after treatment) as the within-subjects factor will be used to assess the presence of significant differences between the two groups and within each group. A Tukey post-hoc comparison will be used to determine significant differences between mean values when a significant main effect and interaction will be found
Statistical analyses will be performed using the MedCalc, version 11.1.1.0 for Windows (MedCalc Software, Mariakerke, Belgium) All analyses will be performed according to the principle of intention-to-treatment, in which patients with missing data will be counted as treatment failures.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
26/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
19
Final
Recruitment outside Australia
Country [1] 23840 0
Italy
State/province [1] 23840 0

Funding & Sponsors
Funding source category [1] 308970 0
University
Name [1] 308970 0
University of L'Aquila
Country [1] 308970 0
Italy
Primary sponsor type
University
Name
University of L'Aquila
Address
Via Giuseppe Petrini - “Rita Levi Montalcini” Building (Delta 6) - 67100 Coppito-L'Aquila
Country
Italy
Secondary sponsor category [1] 309904 0
None
Name [1] 309904 0
N/A
Address [1] 309904 0
N/A
Country [1] 309904 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308858 0
Internal Review Board of the University of L'Aquila
Ethics committee address [1] 308858 0
Palazzo Camponeschi, Piazza Santa Margherita 2, 67100 L’Aquila
Ethics committee country [1] 308858 0
Italy
Date submitted for ethics approval [1] 308858 0
Approval date [1] 308858 0
23/03/2021
Ethics approval number [1] 308858 0
51/2020-21

Summary
Brief summary
Subacromial impingement syndrome (SIS), is a condition characterized by pain, without a history of trauma, located in the rotator cuff tendons, subacromial bursa, biceps tendon and shoulder capsule or in a combination of these structures, which can ultimately lead to shoulder dysfunction, compromising work, sport, or activity of daily living. SIS, accounting for 44% up to 65% of shoulder disorders, is the leading cause of shoulder’s pain, with an increasing incidence by age. Prevalence is particularly higher in some categories of population, like overhead athletes or manual workers, as consequence of the type and repeatability of the movement.
Conservative treatment usually consist of nonsteroidal anti-inflammatory drugs, joint mobilization and manipulation, physical therapy modalities, local steroid injection, and stretching and strengthening exercises.
Among the aforementioned treatments only exercises have shown effectiveness in the treatment of SIS, whereas modalities (i.e., lasers, ultrasounds, etc.) have not been shown to provide additional benefits to exercises in the management of patients with SIS.
Recently, a particular type of segmental muscle vibration, at high frequency (100 Hz) and low amplitude (0.2–0.5 mm), has been shown significant improvement of endurance, strength, power, joint stiffness control, and body image perception both in healthy and in impaired individuals. To our knowledge, no clinical studies have been performed to assess the effectiveness of segmental muscle vibration adding to a convention rehabilitation treatment compared with a conventional rehabilitation treatment alone in patients with SIS.
our hypothesis is that the vibratory energy added to the conventional rehabilitation treatment contributes to improve the effectiveness of the rehabilitation treatment by increasing the range of motion and the strength of the shoulder, compared to the only conventional rehabilitation treatment.
Therefore, the purpose of this clinical study will be to compare the effectiveness of segmental muscle vibration adding to conventional rehabilitation treatment with that of conventional rehabilitation treatment alone in patients with SIS.
Trial website
Trial related presentations / publications
Public notes
N/A

Contacts
Principal investigator
Name 112142 0
Prof Angelo Cacchio
Address 112142 0
University of L'Aquila
Via Giuseppe Petrini - “Rita Levi Montalcini” Building (Delta 6) - 67100 Coppito-L'Aquila
Country 112142 0
Italy
Phone 112142 0
+390862434747
Fax 112142 0
Email 112142 0
angelo.cacchio@univaq.it
Contact person for public queries
Name 112143 0
Dr Gabriele Severini
Address 112143 0
Catholic University of the Sacred Heart of Rome
Largo Francesco Vito, 1 00168 Roma, Italy
Country 112143 0
Italy
Phone 112143 0
+390635347999
Fax 112143 0
Email 112143 0
gabriele.severini@unicatt.it
Contact person for scientific queries
Name 112144 0
Dr Gabriele Severini
Address 112144 0
Catholic University of the Sacred Heart of Rome
Largo Francesco Vito, 1 00168 Roma, Italy
Country 112144 0
Italy
Phone 112144 0
+390635347999
Fax 112144 0
Email 112144 0
gabriele.severini@unicatt.it

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.