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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03528499
Other study ID # 86974318.7.0000.5504
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 21, 2018
Est. completion date November 1, 2020

Study information

Verified date November 2020
Source Universidade Federal de Sao Carlos
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date November 1, 2020
Est. primary completion date November 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Intervention

Other:
Scapular Movement Training
Orientation about the proper scapular position and movement and training to modify the scapular movement pattern.
General Exercises
Strengthening and stretching exercises.

Locations

Country Name City State
Brazil Universidade Federal de São Carlos São Carlos São Paulo

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal de Sao Carlos

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Pre (baseline) and post Treatment (8 weeks)
Secondary Change in Muscle activity from baseline to 8 weeks. Surface electromyographic recorded from scapulothoracic muscles (Upper trapezius, Middle Trapezius, Lower Trapezius and Serratus Anterior). Pre (baseline) and post Treatment (8 weeks)
Secondary 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). Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
Secondary 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). Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
Secondary 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. Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
Secondary 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). Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
Secondary 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. Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
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