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Scapular Movement Training Versus General Exercises for Individuals With Shoulder Pain

Primary Purpose

Shoulder Pain, Musculoskeletal Disease, Joint Disease

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Scapular Movement Training

General Exercises

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Scapula, Physical Therapy, Movement, Rehabilitation

Eligibility Criteria

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

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;

Sites / Locations

Universidade Federal de São Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Scapular Movement Training

General Exercises

Arm Description

Orientation and scapular exercises, performed twice a week, for 8 weeks.

Scapulothoracic muscle stretching and strengthening exercises, performed twice a week, for 8 weeks.

Outcomes

Primary Outcome Measures

Change in Three-Dimensional Scapular Kinematics from baseline to 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).

Secondary Outcome Measures

Change in Muscle activity from baseline to 8 weeks.

Surface electromyographic recorded from scapulothoracic muscles (Upper trapezius, Middle Trapezius, Lower Trapezius and Serratus Anterior).

Change in Pain from baseline to follow-up.

The pain will be measured with 11 point - Numerical Rating Pain Scale with scores ranging from 0 (no pain) to 10 (maximum pain).

Change in Function from baseline to follow-up.

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).

Change in Fear-Avoidance Beliefs from baseline to follow-up.

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.

Change in Overall improvement of Symptoms from baseline to follow-up.

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).

Change in Kinesiophobia from baseline to follow-up

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.

Full Information

NCT ID

NCT03528499

First Posted

April 23, 2018

Last Updated

November 5, 2020

Sponsor

Universidade Federal de Sao Carlos

1. Study Identification

Unique Protocol Identification Number

NCT03528499

Brief Title

Scapular Movement Training Versus General Exercises for Individuals With Shoulder Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

August 21, 2018 (Actual)

Primary Completion Date

November 1, 2020 (Actual)

Study Completion Date

November 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade Federal de Sao Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder Pain, Musculoskeletal Disease, Joint Disease, Shoulder Injury

Keywords

Scapula, Physical Therapy, Movement, Rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Scapular Movement Training

Arm Type

Experimental

Arm Description

Orientation and scapular exercises, performed twice a week, for 8 weeks.

Arm Title

General Exercises

Arm Type

Active Comparator

Arm Description

Scapulothoracic muscle stretching and strengthening exercises, performed twice a week, for 8 weeks.

Intervention Type

Other

Intervention Name(s)

Scapular Movement Training

Other Intervention Name(s)

Orientation and training

Intervention Description

Orientation about the proper scapular position and movement and training to modify the scapular movement pattern.

Intervention Type

Other

Intervention Name(s)

General Exercises

Other Intervention Name(s)

Exercises

Intervention Description

Strengthening and stretching exercises.

Primary Outcome Measure Information:

Title

Change in Three-Dimensional Scapular Kinematics from baseline to 8 weeks.

Description

3-D Scapular kinematics (upward/downward rotation; internal/external rotation; anterior/posterior tilt) will be measured by an electromagnetic tracking system (in degrees).

Time Frame

Pre (baseline) and post Treatment (8 weeks)

Secondary Outcome Measure Information:

Title

Change in Muscle activity from baseline to 8 weeks.

Description

Surface electromyographic recorded from scapulothoracic muscles (Upper trapezius, Middle Trapezius, Lower Trapezius and Serratus Anterior).

Time Frame

Pre (baseline) and post Treatment (8 weeks)

Title

Change in Pain from baseline to follow-up.

Description

The pain will be measured with 11 point - Numerical Rating Pain Scale with scores ranging from 0 (no pain) to 10 (maximum pain).

Time Frame