NCT04104906

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2019

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

8 months

First QC Date

June 28, 2019

Last Update Submit

April 29, 2021

Conditions

Keywords

Shoulder rehabilitationElectromyographyPosture analysis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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)

motor control training

EXPERIMENTAL

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

Other: motor control training

exercises

ACTIVE COMPARATOR

8-week exercise program, twice a week.

Other: The exercise group

Interventions

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.

motor control training

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.

exercises

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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;
  • 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.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jamilson S Brasileiro

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

Location

Karinna Sonálya Aires da Costa

Parnamirim, Rio Grande do Norte, 59152820, Brazil

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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

Study Record Dates

First Submitted

June 28, 2019

First Posted

September 26, 2019

Study Start

June 17, 2019

Primary Completion

January 30, 2020

Study Completion

January 30, 2020

Last Updated

April 30, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations