sEmg Biofeedback Training in Individuals With Subacromial Pain Syndrome

NCT04043884 | Unknown

• 1 other identifier: AKAO2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Shoulder Pain

Keywords

Shoulder rehabilitation; Electromyography; Posture analysis

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (5)

• Root Mean Square (RMS)

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

• The kinematics of the scapula

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

• Peak of muscular torque

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

• Peak torque time

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

• Range of motion

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

Study Arms (2)

sEmg Biofeedback training

EXPERIMENTAL

8-week exercise program, twice a week, with emg biofeedback training.

Other: sEmg biofeedback training

Exercises

ACTIVE COMPARATOR

8-week exercise program, twice a week.

Other: Strength training

Interventions

sEmg biofeedback training OTHER

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.

sEmg Biofeedback training

Strength training OTHER

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

Exercises

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

Study Sites (2)

Jamilson Simões Brasileiro

Natal, Rio Grande do Norte, 59140-840, Brazil

Location

Araken kleber Azevedo de Oliveira

Parnamirim, Rio Grande do Norte, 59158178, Brazil

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Araken Oliveira, Ms

  Universidade Federal do Rio Grande do Norte

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamilson Brasileiro, PhD

CONTACT

(84)33422008; brasileiro@ufrnet.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Therapy and Lab Head

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 2, 2019
• Study Start: August 30, 2019
• Primary Completion: December 30, 2019
• Study Completion: March 30, 2020
• Last Updated: August 7, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)