- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03528499
Scapular Movement Training Versus General Exercises for Individuals With Shoulder Pain
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
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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São Paulo
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São Carlos, São Paulo, Brazil, 13565-905
- Universidade Federal de Sao Carlos
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Orientation about the proper scapular position and movement and training to modify the scapular movement pattern.
Other Names:
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Active Comparator: General Exercises
Scapulothoracic muscle stretching and strengthening exercises, performed twice a week, for 8 weeks.
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Strengthening and stretching exercises.
Other Names:
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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)
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3-D Scapular kinematics (upward/downward rotation; internal/external rotation; anterior/posterior tilt) will be measured by an electromagnetic tracking system (in degrees).
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Pre (baseline) and post Treatment (8 weeks)
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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)
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Surface electromyographic recorded from scapulothoracic muscles (Upper trapezius, Middle Trapezius, Lower Trapezius and Serratus Anterior).
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Pre (baseline) and post Treatment (8 weeks)
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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 )
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The pain will be measured with 11 point - Numerical Rating Pain Scale with scores ranging from 0 (no pain) to 10 (maximum pain).
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Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
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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 )
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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).
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Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
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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 )
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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.
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Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
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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 )
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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).
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Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
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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 )
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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.
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Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
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Collaborators and Investigators
Investigators
- Study Director: Paula Camargo, PhD, Universidade Federal de Sao Carlos
Publications and helpful links
General Publications
- Kamonseki DH, Haik MN, Ribeiro LP, Almeida RF, Camargo PR. Scapular movement training is not superior to standardized exercises in the treatment of individuals with chronic shoulder pain and scapular dyskinesis: randomized controlled trial. Disabil Rehabil. 2022 Aug 24:1-11. doi: 10.1080/09638288.2022.2114552. Online ahead of print.
- Kamonseki DH, Haik MN, Camargo PR. Scapular movement training versus standardized exercises for individuals with chronic shoulder pain: protocol for a randomized controlled trial. Braz J Phys Ther. 2021 Mar-Apr;25(2):221-229. doi: 10.1016/j.bjpt.2020.08.001. Epub 2020 Aug 18.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 86974318.7.0000.5504
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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