NCT03528499

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

August 21, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

2.2 years

First QC Date

April 23, 2018

Last Update Submit

November 5, 2020

Conditions

Keywords

ScapulaPhysical TherapyMovementRehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in Muscle activity from baseline to 8 weeks.

    Pre (baseline) and post Treatment (8 weeks)

  • Change in Pain from baseline to follow-up.

    Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )

  • Change in Function from baseline to follow-up.

    Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )

  • 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 )

  • 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 )

  • +1 more secondary outcomes

Study Arms (2)

Scapular Movement Training

EXPERIMENTAL

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

Other: Scapular Movement Training

General Exercises

ACTIVE COMPARATOR

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

Other: General Exercises

Interventions

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

Also known as: Orientation and training
Scapular Movement Training

Strengthening and stretching exercises.

Also known as: Exercises
General Exercises

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Shoulder pain intensity ≥ 3 points on Numerical Rating Scale;
  • Shoulder pain lasting ≥ 3 months;
  • Scapular dyskinesis;
  • Positive Scapular Assistance Test;
  • Arm elevation ≥ 150°;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de São Carlos

São Carlos, São Paulo, 13565-905, Brazil

Location

Related Publications (2)

  • 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. 2023 Sep;45(18):2925-2935. doi: 10.1080/09638288.2022.2114552. Epub 2022 Aug 24.

  • 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.

MeSH Terms

Conditions

Shoulder PainMusculoskeletal DiseasesJoint DiseasesShoulder Injuries

Interventions

Exercise

Condition Hierarchy (Ancestors)

ArthralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Paula Camargo, PhD

    Universidade Federal de Sao Carlos

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ms, PT

Study Record Dates

First Submitted

April 23, 2018

First Posted

May 17, 2018

Study Start

August 21, 2018

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

November 9, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations