Scapular Movement Training Versus General Exercises for Individuals With Shoulder Pain

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03528499
• Other study ID #: 86974318.7.0000.5504
• Status: Completed
• Phase: N/A
• 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
• 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;

Related Conditions & MeSH terms

• Joint Disease
• Joint Diseases
• Musculoskeletal Disease
• Musculoskeletal Diseases
• Shoulder Injuries
• Shoulder Injury
• Shoulder Pain

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 )