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Shoulder PainNCT04043884

sEmg Biofeedback Training in Individuals With Subacromial Pain Syndrome

A study testing sEmg biofeedback training and Strength training in people with Shoulder Pain, run by Universidade Federal do Rio Grande do Norte at 2 sites in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Objective: To investigate the effects of EMG biofeedback training on the pattern of scapular muscle activation and kinematics in subjects with subacromial pain syndrome. Methods: This is a randomized controlled trial, which will be composed of 40 volunteers of both genders, aged between 30 and 60 years. Read more about this study

Who is it for?
Ages 30 to 60 years
Conditions the study is for
Shoulder Pain
What is being tested?
sEmg biofeedback training and Strength training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesBrazil
Study dates
30 Aug 2019to 30 Mar 2020
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 30 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Present subacromial pain with a score greater than or equal to 2 (Visual Analog Scale) for more than 2 months;
  • Positive Neer test;
  • Positive Hawkins test;
  • Positivie Jobe test (pain);
  • Positive Patte test (pain);
  • Involvement of the supraspinatus and / or infraspinatus tendon (without degenerative characteristics) confirmed by Magnetic Nuclear Resonance (MRI) examination.

Who cannot join

  • Intense pain during the evaluations;
  • Fail to properly perform the evaluation procedures;
  • Two consecutive or five alternating absences during the training protocol.

Trial locations and contacts

2 sites in 1 country.

Jamilson Brasileiro, PhD contact

(84)33422008

brasileiro@ufrnet.br

Brazil2 sites
  • Jamilson Simões Brasileiro

    Natal, Rio Grande do Norte, 59140-840

    Jamilson Brasileiro, PhD, (84) 33422008, brasileiro@ufrnet.br

  • Araken kleber Azevedo de Oliveira

    Parnamirim, Rio Grande do Norte, 59158178

    Araken Oliveira, Msc, (84)20300771, arakenkleber@hotmail.com

Other trials in Brazil

About this study

Official title: sEmg Biofeedback Training in Individuals With Subacromial Pain Syndrome: Randomized Controlled Trial

Objective: To investigate the effects of EMG biofeedback training on the pattern of scapular muscle activation and kinematics in subjects with subacromial pain syndrome. Methods: This is a randomized controlled trial, which will be composed of 40 volunteers of both genders, aged between 30 and 60 years. All volunteers will undergo pre-assessment (IA): pain sensation, pain and function, shoulder range of motion, muscle strength, electromyographic activity and kinematics of the shoulder complex. After the initial evaluation, the volunteers will be randomly divided into two groups for the intervention: exercises group (GE - conventional exercises with elastic band) and Biofeedback group (BG - Biofeedback training). The intervention protocol will last eight weeks. After four weeks, the second assessment (SA), similar to IA, will be performed and the global change perception questionnaire will be added. At the end of the intervention protocol, the third evaluation (TA), similar to SA, will be performed. A follow-up will be performed 4 weeks after the end of the intervention protocol, with the assessment being equal to TA. Statistical Analysis will be performed through Statistical Package for Social Sciences (SPSS) software version 20.0 for Windows, following the principles of intention-to-treat analysis. The descriptive analysis will use the mean as a measure of central tendency and the standard deviation as a measure of dispersion. A mixed model ANOVA will be performed for intra and intergroup comparisons.

Read the detailed description

This work was submitted to the Ethics and Research Committee (CEP) of the Federal University of Rio Grande do Norte through the national interface "Plataforma Brasil" and approved in its ethical aspects based on Resolution 466/12 of the National Health Council and the Declaration of Helsinki under registration number 3246854. All data will be registered in a confidential database of the laboratory and can only be handled by the responsible researchers. All individuals will be invited to voluntarily participate in the study and must sign the Free and Informed Consent Form (FICF) containing information about the purposes, risks and benefits of the research. A pilot study was carried out aiming at the adequacy of all the research procedures, as well as the training of the researchers involved. After signing the FICF sociodemographic, anthropometric and clinical data will be collected and then the individuals will be submitted to the evaluation procedures. Four identical evaluations will be carried out before, during and after the intervention protocol. Initially, initial assessment (IA) will record the baseline data prior to the protocol, the second assessment (SA) will be performed after the first four weeks of protocol, the third (TA) at the end of the 8 week intervention protocol, and the fourth (FA) four weeks after the end of the protocol. The evaluation of the pain sensation will be performed through the numerical pain scale. Volunteers will be instructed by the evaluator to scale the intensity of pain based on the last 24 hours. The scale is composed of 11 items, 0 being described as "painless" and 10 as "worst possible pain" at its extremities. Participants will then complete the Brazilian version of the Desabilities of the arm, shoulder and Hand (DASH) questionnaire. It is a self-assessment questionnaire containing 30 questions with the purpose of assessing physical function, symptoms and social function. Five possible responses are presented ranging from "no difficulty" to "unable to perform activity". Responses are scored on a rating scale of one to five points. The score calculation is performed by applying established formulas. Volunteers will be instructed by the evaluator to complete the items in the questionnaire that have been applicable in the last 24 hours. The higher the final score, the greater the disability. Motion amplitudes will be evaluated by the Smartphone clinometer application (Plaincode Software Solutions) which operates as a reliable and validated inclinometer. The Range Of Motion (ROM) of flexion, hyperextension, lateral rotation and medial rotation of the shoulder will be evaluated. The flexion and the hyperextension of the shoulder will be evaluated in the sitting position. The evaluator will position the smartphone parallel to the subject's arm secured in an appropriate device, aligned to the lateral epicondyle of the elbow and will request flexion and active hyperextension respectively of the shoulder with the elbow in complete extension. Lateral and medial rotation of the shoulder will be evaluated with the volunteer in the supine position at the table, shoulder abducted at 90 ° and elbows at 90 ° flexion. The evaluator will position the smartphone on the forearm of the individual aligned between the lateral epicondyle and the wrist and between the medial epicondyle and the wrist for the medial and lateral rotation movement respectively. Peak torque evaluation will be perfomed using a portable hand held dynamometer (Lafayette Instrument®, model 01165, USA). Data will be recorded from two 5 seconds maximum voluntary isometric contractions (MVIC), with a 1-minute interval. The average of the two tests will be considered for analysis. The evaluation will be carried out by the same evaluator and will be positioned in such a way as to counteract the requested movement. The electromyographic signal will be captured by an 8-channel signal conditioning modulator (Noraxon® surface, Scottsdale, AZ, USA) with a 16-bit resolution and common mode rejection rate> 100 Db. The signals will be captured at a sample rate set to 1500 Hz, filtered at a frequency between 10 and 500 Hz and amplified 1000 times. Signal capture will be performed using passive surface self-adhesive electrodes (Noraxon®, USA), separated by an inter-electrode distance of 2 cm. The electrodes were placed in the Upper Trapezius (UT), Lower Trapezius (LT), Middle Trapezius (MT) and Serratus Anterior (SA) muscles, in accordance with the SENIAM guidelines . First, individuals will perform three movements of arm elevations in the plane of the scapula in the standing position. The arm will be positioned at 40 degrees from the frontal plane measured by MotionMonitor software (Innovative Sports Training, Chicago, IL) of kinematic analysis and the motion will be directed with the aid of a vertical support. Each movement should occur in approximately eight seconds with four seconds in the concentric phase and four seconds in the eccentric phase. The subjects will then perform isometric contractions of 5 seconds with and without load at angles 30 °, 60 °, 90 ° and 120 ° of shoulder abduction. The load will be determined from a test with the same movement with dumbbells of 2kg, 1kg and 0.5kg respectively Taking as reference a score not higher than 3 on the Borg effort scale (moderate effort). The Root Means Square averages for each phase will be recorded and the ratios UT / LT, UT / MT, UT / SA will be analyzed. The electromyographic data (in microvolts) will be normalized by the peak of the signal recorded during the MVIC. The three-dimensional analysis of the movement of the shoulder complex will be performed using the Flock of Birds (Ascension Technologies, Burlington, VT) electromagnetic tracking system associated with MotionMonitor software (Innovative Sports Training, Chicago, IL). Volunteers will be asked to stay in a neutral position with the transmitter directly in the shoulder joint to be evaluated and three superficial electromagnetic sensors will be positioned to the skin of the volunteers in pre-established anatomical marks. A double-sided tape will be used, in specific anatomical points: in the sternum, inferiorly to the sternal furcula; on a flat surface in the posterior and medial part of the acromion process; and one fixed at the junction of the deltoids attached with velcro to the volunteers' arm directly above the epicondyles of the humerus. A sensor will be connected to a stylus, for digitizing the anatomical points and constructing the coordinate system for each joint. The anatomical coordinate systems will be established for each segment by the digitization of the anatomical marks according to the protocol recommended by the International Society of Biomechanics - ISB36. The anatomical marks will be palpated and marked by a researcher who has experience with the protocol. then it will be estimated by passively moving the arm in short rotation amplitudes in several different positions. After completing the scan, the volunteers will assume a neutral standing position, with their arms resting in the body sludge, for approximately five seconds (time required for the angular values to be recorded).

The kinematic evaluation will be performed concomitantly with the recording of electromyographic activity. After the evaluation the subjects will be randomly distributed in Exercise Group (EG) and Biofeedback Group (BG) through the site www.randomization.com. GE and GB should attend twice a week, for eight consecutive weeks to the physiotherapy department of UFRN to carry out their respective intervention protocols. Each session will have an average duration of 30 minutes and should be justified in case of absence. All will be instructed to perform ice packs for 30 minutes in case of severe pain. The GE will perform a strengthening protocol and will have four elastic bands with different resistances available (light (red), moderate (blue), strong (purple) and extra strong (gray) for the progression of elbow flexion exercises, medial rotation of the shoulder, lateral rotation of the shoulder and scapular retraction. To determine the initial load the individual will perform a series of 10 repetitions of each exercise with the moderate resistance band (blue) and should not present pain greater than that reported in the initial evaluation and score above "moderate". For the exercise called "push up plus "the initial load will be determined from the kneeling position supported with the hands in the step using the same criteria of pain and scores of the borg scale mentioned above. The intensity progression will be due to the complexity of the exercise. Biofeedback (GB) volunteers will perform the same GE exercises added to the sEMG biofeedback in the upper trapezius (UT), Middle Trapezius (MT), Lower Trapezius (LT), and Anterior Serratil (AS) muscles in real time displayed in a computer screen during exercises. In the Y-axis of the screen the EMG amplitude is displayed and in the X-axis the time domain Volunteers will be instructed to change their movement strategies in order to decrease TS activity and facilitate MT, LT, and AS activity during exercises by viewing the computer screen. The researcher should guide the process through the verbal command.

Conditions
Shoulder Pain
Being tested
sEmg biofeedback training, Strength training
Keywords
Shoulder rehabilitation, Electromyography, Posture analysis
Medical subject headings
Shoulder Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sEmg biofeedback trainingOther

    Volunteers will perform scapular strengthening and stabilization exercises added to sEMG biofeedback in the upper trapezius (TS), Trapezius (TM), Lower Trapezius (TI), and Serratil Anterior (AS) muscles in real time displayed in a Computer screen.

  • Strength trainingOther

    The volunteers will perform a strengthening protocol with elbow flexion exercises, medial and lateral shoulder rotation, scapular retraction and push up plus.

Study groups in NCT04043884
Study groupRoleWhat they receive
sEmg Biofeedback trainingExperimental8-week exercise program, twice a week, with emg biofeedback training.
Receives: Other: sEmg biofeedback training
ExercisesActive comparator8-week exercise program, twice a week.
Receives: Other: Strength training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Shouder pain

    Evaluation of pain level in the shoulder using the Numerical Pain Scale, graded from 0 to 10, where 0 indicates absence of pain and 10 indicates the worst pain imaginable.

    Measured: Change from baseline in shoulder pain at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol

  2. Shoulder function

    Evaluation of shoulder pain and function using the Disabilities of the Arm, Shoulder and Hand (DASH). The questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. The higher the score, the greater the functional disability.

    Measured: Change from baseline in shoulder function at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol

Secondary outcomes (5)
  1. Root Mean Square (RMS)

    Analyze of the electromyographic activity of the shoulder complex muscles, after 4 and 8 weeks of the protocol and a follow up of 4 weeks after the intervention protocol, by Root Mean Square (RMS)

    Measured: Change from baseline in RMS at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol

  2. The kinematics of the scapula

    Analyze the kinematics of the scapula and glenohumeral in the slow and habitual movements after 4 and 8 weeks of the beginning of the protocol and a follow up of 4 weeks.

    Measured: Change from baseline in kinematics of the scapular girdle at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol

  3. Peak of muscular torque

    Evaluate the peak of muscular torque, after 4 and 8 weeks of the beginning of the protocol and a follow up of 4 weeks, using the hand-held dynamometer.

    Measured: Change from baseline in peak of muscular torque at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol

  4. Peak torque time

    Evaluate the peak torque time, after 4 and 8 weeks of the beginning of the protocol and a follow up of 4 weeks, using the hand-held dynamometer

    Measured: Change from baseline in peak torque time at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol

  5. Range of motion

    Measure the range of motion for flexion, hyperextension, internal and external shoulder rotation after 4 and 8 weeks of the beginning of the protocol and a follow up of 4 weeks, using the inclinometer.

    Measured: Change from baseline in range of motion at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2019
  2. Study start30 Aug 2019 (estimated)
  3. Primary completion30 Dec 2019 (estimated)
  4. Study completion30 Mar 2020 (estimated)

Resources

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
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04043884
Sponsor's protocol ID
AKAO2019
Status last verified
Aug 2019
First submitted
31 Jul 2019
Last updated
7 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing sEmg biofeedback training and Strength training in people with Shoulder Pain, run by Universidade Federal do Rio Grande do Norte at 2 sites in Brazil.

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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jamilson Brasileiro, PhD ((84)33422008, brasileiro@ufrnet.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Shouder pain (time frame: Change from baseline in shoulder pain at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol). The study lists 2 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 7 Aug 2019.

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