Motor Control Training in Individuals With Subacromial Pain Syndrome

Shoulder Pain Clinical Trial

Official title:

Motor Control Training in Individuals With Subacromial Pain Syndrome: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04104906
• Other study ID #: KSACO2019
• Status: Completed
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: April 2021
• Source: Universidade Federal do Rio Grande do Norte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The porpusose of this study is to evaluate the repercussions of a motor control exercise protocol in patients with subacromial pain syndrome without indication of surgical repair.

Description:

Methods: This is a randomized controlled trial which will be composed of volunteers of both genders, aged between 35 and 60 years. All volunteers will undergo pre-assessment (Av1): 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 to carry out the intervention: exercises (GE - conventional exercises with elastic band) and motor control (GCM - motor control training). The intervention protocol will last eight weeks. After four weeks, the second assessment (AV2), similar to AV1, will be performed and the global change perception questionnaire will be added. At the end of the intervention protocol, the third evaluation (AV3), similar to AV2, will be performed. A follow-up will be performed after 4 weeks of the end of the intervention protocol, with the assessment being equal to AV3.

The project will be submitted to the Research Ethics Committee of the Federal University of Rio Grande do Norte through the national interface "Plataforma Brasil". The study will also be registered on the international clinical trial platform, ClinicalTrials.gov. The study will only begin after approval of the ethics and research committee. All volunteers should read and sign the terms of free and informed consent.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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;

• Positive 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.

Exclusion Criteria:

• Intense pain during the evaluations;

• Fail to properly perform the evaluation procedures;

• Two consecutive or five alternating absences during the training protocol.

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Other:
• motor control training
The volunteers of the motor control group will initiate the exercises on a stable and rigid basis. These will be progressed with adding an unstable base as the volunteer gains motor learning (between the fourth and fifth week of the protocol). For the motor control group, two sets of 10 repetitions will be performed keeping in isometry for ten seconds each repetition.
• The exercise group
the protocol of strengthening and will have five elastic bands with different resistances available (extra-light, light, moderate, strong and extra-strong) for elbow flexion exercises progression, medial rotation and lateral rotation of the shoulder and scapular retraction.

Locations

Country	Name	City	State
Brazil	Jamilson S Brasileiro	Natal	RN
Brazil	Karinna Sonálya Aires da Costa	Parnamirim	RN

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder 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
Primary	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	Root Mean Square (RMS)	Analyze of the electromyographic activity of the muscles shoulder complex, after 4 and 8 weeks of the protocol and a follow up of 4 weeks after the intervention protocol, by Root Mean Square (RMS)	Change from baseline in RMS at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Secondary	The kinematics of the scapula	Analyze the kinematics of the scapula and glenohumeral in the slow and habitual movements after 8 weeks of the protocol and a follow up of 4 weeks.	Change from baseline in kinematics of the scapular girdle at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Secondary	Peak of muscular torque	Evaluate the peak of muscular torque, by means of the manual dynamometer 8 weeks of the protocol and a follow up of 4 weeks.	Change from baseline in peak of muscular torque at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Secondary	Peak torque time	Evaluate the peak torque time, using the manual dynamometer 8 weeks of the protocol and a follow up of 4 weeks.	Change from baseline in peak torque time at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Secondary	Range of motion	Measure the range of motion for flexion, hyperextension, internal and external shoulder rotation 8 weeks of protocol and a follow up of 4 weeks, through the inclinometer.	Change from baseline in range of motion at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol