Scapular Movement Training Versus General Exercises for Individuals With Shoulder Pain

Sponsor
Universidade Federal de Sao Carlos (Other)
Overall Status
Completed
CT.gov ID
NCT03528499
Collaborator
(none)
64
1
2
26.4
2.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Scapular Movement Training
  • Other: General Exercises
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Scapular Movement Training Versus General Exercises for Individuals With Shoulder Pain: Randomized Controlled Trial
Actual Study Start Date :
Aug 21, 2018
Actual Primary Completion Date :
Nov 1, 2020
Actual Study Completion Date :
Nov 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Scapular Movement Training

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

Other: Scapular Movement Training
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.

    Other: General Exercises
    Strengthening and stretching exercises.
    Other Names:
  • Exercises
  • Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Change in Muscle activity from baseline to 8 weeks. [Pre (baseline) and post Treatment (8 weeks)]

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

    2. Change in Pain from baseline to follow-up. [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).

    3. Change in Function from baseline to follow-up. [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).

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

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

    6. Change in Kinesiophobia from baseline to follow-up [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universidade Federal de São Carlos São Carlos São Paulo Brazil 13565-905

    Sponsors and Collaborators

    • Universidade Federal de Sao Carlos

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Danilo Harudy Kamonseki, Ms, PT, Universidade Federal de Sao Carlos
    ClinicalTrials.gov Identifier:
    NCT03528499
    Other Study ID Numbers:
    • 86974318.7.0000.5504
    First Posted:
    May 17, 2018
    Last Update Posted:
    Nov 9, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Danilo Harudy Kamonseki, Ms, PT, Universidade Federal de Sao Carlos
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 9, 2020