Scapular Movement Training Versus General Exercises for Individuals With Shoulder Pain

November 5, 2020 updated by: Danilo Harudy Kamonseki, Universidade Federal de Sao Carlos

Scapular Movement Training Versus General Exercises for Individuals With Shoulder Pain: Randomized Controlled Trial

Interventions focused on the scapula have been frequently used to treat shoulder pain. However, most studies do not assess the contribution of scapular movement alteration for the symptoms.

Objectives: To compare the effects of two interventions for shoulder pain: Scapular Movement Training and General Exercises.

Study Overview

Detailed Description

This is a double-blinded randomized controlled trial. Sixty-four subjects with shoulder pain, scapular dyskinesis, and positive scapular assistance test will be randomized in two groups: 1) Scapular Movement Training, and 2) General Exercises. The Scapular Movement Training Group will receive the orientation about proper scapular position and movement, and will be trained to modify the scapular movement pattern. The General Exercises Group will perform scapulothoracic stretching and strengthening exercises.

Both groups will be treated twice a week for eight weeks. The following outcomes will be collected at baseline and follow-up: scapular kinematics, electromyographic muscle activity of the upper, middle and lower trapezius, and serratus anterior, as well as pain intensity, function, and fear avoidance beliefs. Also, pain intensity, function, and fear-avoidance beliefs will be assessed at the fourth week of follow-up after the end of treatment's period.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • São Paulo
      • São Carlos, São Paulo, Brazil, 13565-905
        • Universidade Federal de Sao Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Shoulder pain intensity ≥ 3 points on Numerical Rating Scale;
  • Shoulder pain lasting ≥ 3 months;
  • Scapular dyskinesis;
  • Positive Scapular Assistance Test;
  • Arm elevation ≥ 150°;

Exclusion Criteria:

  • Body Mass index > 28Kg/m
  • History of humerus, clavicle and scapula fracture and/or surgery;
  • History of rotator cuff surgery or tears, shoulder dislocation, and instability;
  • Frozen Shoulder;
  • Neurological or systemic disease which may alter the muscle strength and sensibility;
  • Positive Upper Limb Tension Test and/or Spurling's test
  • Pregnancy;
  • Physical therapy within 6 months;
  • Corticosteroid injection within 3 months
  • Transpore tape allergy;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Scapular Movement Training
Orientation and scapular exercises, performed twice a week, for 8 weeks.
Orientation about the proper scapular position and movement and training to modify the scapular movement pattern.
Other Names:
  • Orientation and training
Active Comparator: General Exercises
Scapulothoracic muscle stretching and strengthening exercises, performed twice a week, for 8 weeks.
Strengthening and stretching exercises.
Other Names:
  • Exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Three-Dimensional Scapular Kinematics from baseline to 8 weeks.
Time Frame: Pre (baseline) and post Treatment (8 weeks)
3-D Scapular kinematics (upward/downward rotation; internal/external rotation; anterior/posterior tilt) will be measured by an electromagnetic tracking system (in degrees).
Pre (baseline) and post Treatment (8 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Muscle activity from baseline to 8 weeks.
Time Frame: Pre (baseline) and post Treatment (8 weeks)
Surface electromyographic recorded from scapulothoracic muscles (Upper trapezius, Middle Trapezius, Lower Trapezius and Serratus Anterior).
Pre (baseline) and post Treatment (8 weeks)
Change in Pain from baseline to follow-up.
Time Frame: Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
The pain will be measured with 11 point - Numerical Rating Pain Scale with scores ranging from 0 (no pain) to 10 (maximum pain).
Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
Change in Function from baseline to follow-up.
Time Frame: Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
The Function will be measured with Disabilities of the Arm, Shoulder and Hand with scores ranging from 0 to 100 (higher score reflects greater disability).
Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
Change in Fear-Avoidance Beliefs from baseline to follow-up.
Time Frame: Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
The Fear-Avoidance Beliefs Questionnaire (FABQ) contains 2 scales: FABQ work scale (with range from 0 to 42) and FABQ physical activity scale (with range from 0 to 24). Higher scores indicate higher levels of fear-avoidance beliefs.
Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
Change in Overall improvement of Symptoms from baseline to follow-up.
Time Frame: Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
The Overall improvement of Symptoms will be measured with the Global Rating of Change Scale with scores ranging from -7 to +7 (A higher score indicates higher recovery from the condition).
Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
Change in Kinesiophobia from baseline to follow-up
Time Frame: Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
The Kinesiophobia will be measured with Tampa Scale of Kinesiophobia (TKS) with scores ranging from 17 to 68. Higher scores indicate higher degree of kinesiophobia.
Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Paula Camargo, PhD, Universidade Federal de Sao Carlos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2018

Primary Completion (Actual)

November 1, 2020

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

April 23, 2018

First Submitted That Met QC Criteria

May 5, 2018

First Posted (Actual)

May 17, 2018

Study Record Updates

Last Update Posted (Actual)

November 9, 2020

Last Update Submitted That Met QC Criteria

November 5, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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