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Motor Control Training in Individuals With Subacromial Pain Syndrome

Primary Purpose

Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
motor control training
The exercise group
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Shoulder rehabilitation, Electromyography, Posture analysis

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jamilson S Brasileiro
  • Karinna Sonálya Aires da Costa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

motor control training

exercises

Arm Description

8-week exercise program, twice a week, with motor control training

8-week exercise program, twice a week.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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)
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.
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.
Peak torque time
Evaluate the peak torque time, using the manual dynamometer 8 weeks of the protocol and a follow up of 4 weeks.
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.

Full Information

First Posted
June 28, 2019
Last Updated
April 29, 2021
Sponsor
Universidade Federal do Rio Grande do Norte
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1. Study Identification

Unique Protocol Identification Number
NCT04104906
Brief Title
Motor Control Training in Individuals With Subacromial Pain Syndrome
Official Title
Motor Control Training in Individuals With Subacromial Pain Syndrome: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 17, 2019 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Shoulder rehabilitation, Electromyography, Posture analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
motor control training
Arm Type
Experimental
Arm Description
8-week exercise program, twice a week, with motor control training
Arm Title
exercises
Arm Type
Active Comparator
Arm Description
8-week exercise program, twice a week.
Intervention Type
Other
Intervention Name(s)
motor control training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
The exercise group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Shoulder pain
Description
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.
Time Frame
Change from baseline in shoulder pain at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Title
Shoulder function
Description
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.
Time Frame
Change from baseline in shoulder function at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Secondary Outcome Measure Information:
Title
Root Mean Square (RMS)
Description
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)
Time Frame
Change from baseline in RMS at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Title
The kinematics of the scapula
Description
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.
Time Frame
Change from baseline in kinematics of the scapular girdle at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Title
Peak of muscular torque
Description
Evaluate the peak of muscular torque, by means of the manual dynamometer 8 weeks of the protocol and a follow up of 4 weeks.
Time Frame
Change from baseline in peak of muscular torque at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Title
Peak torque time
Description
Evaluate the peak torque time, using the manual dynamometer 8 weeks of the protocol and a follow up of 4 weeks.
Time Frame
Change from baseline in peak torque time at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Title
Range of motion
Description
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.
Time Frame
Change from baseline in range of motion at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Jamilson S Brasileiro
City
Natal
State/Province
RN
ZIP/Postal Code
59140-840
Country
Brazil
Facility Name
Karinna Sonálya Aires da Costa
City
Parnamirim
State/Province
RN
ZIP/Postal Code
59152820
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Motor Control Training in Individuals With Subacromial Pain Syndrome

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