Effects of Scapular Therapeutic Exercise on Essential Biomechanical and Neurophysiological Parameters in Shoulder Pain Conditions With Scapular Impairments

July 28, 2024 updated by: Ana Melo, Polytechnic Institute of Porto

Shoulder pain is a prevalent and recurrent condition. After a period of shoulder pain, some adaptations could be found, as in scapular muscles and kinematics and/or in nervous system.

It seems important to assess several biomechanical and neurophysiological outcomes to better characterize shoulder pain conditions and to program an intervention plane.

Therapeutic exercise is one of the treatments used for shoulder pain, however there are still doubts and controversial findings regarding exercise focusing the scapular musculature. Thus, the present study aims to assess the effects of an intervention protocol based on scapular therapeutic exercise.

Study Overview

Status

Completed

Conditions

Detailed Description

The study only started after approval of the protocol

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Porto, Portugal, 4200 - 072
        • Center for Rehabilitation Research, School of Health, Polytechnic of Porto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 to 65 years old
  • Chronic (more than 3 months), continuously or intermittently, non-specific or associated with a diagnostic (except if mentioned in the exclusion criteria) shoulder pain of, at least, moderate intensity
  • Presenting scapular alterations as scapular dyskinesis (identified at rest or during motion)

Exclusion Criteria:

  • History of shoulder fracture, dislocation, tears, infection or neoplasm
  • Shoulder surgery
  • Cervical and/or thoracic pathologies or pain associated with active movements of these regions
  • Neurological disease
  • Body mass index out of the range 18,5-30 kg/m2 and muscular skinfold higher than 20mm
  • Inability to perform the exercises
  • Current practice of competitive/high-level exercise/sport focusing the upper limb

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Scapular Therapeutic Exercise Group
Patients in this group will perform therapeutic exercises, recommended for subjects with shoulder pain and focusing the neuromuscular control, stretching and/or strengthening of the scapular muscles

All subjects will perform a program of scapular therapeutic exercises including: neuromuscular control/strength - scapular therapeutic exercises that leads to, at least, moderate muscular activity levels; and stretching exercises.

The intervention period will be of 8 weeks, considering in-person and/or home sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in shoulder pain
Time Frame: Baseline and one week after intervention
The intensity of pain will be measured with a self-reported 11-point scale (Numerical Rating Pain Scale), with scores ranging from 0 (no pain) to 10 (maximum pain)
Baseline and one week after intervention
Change in shoulder function
Time Frame: Baseline and one week after intervention
Shoulder functional status will be measured with a self-reported 13 items scale (SPADI), which ranges from 0 (fully functional) to 100 (maximum degree of disability).
Baseline and one week after intervention
Change in scapular muscles activity levels
Time Frame: Baseline and one week after intervention
Scapular muscles activity levels, during shoulder analytical movements and during a functional task, will be recorded superficially by a wireless electromyographic signal detector system
Baseline and one week after intervention
Change in scapular muscles ratio
Time Frame: Baseline and one week after intervention
Ratio between scapular muscles activity levels, during shoulder analytical movements and during a functional task, will be calculated considered the superficially eletromyographic data measured by a wireless electromyographic signal detector system.
Baseline and one week after intervention
Change in kinematics
Time Frame: Baseline and one week after intervention
Scapular kinematics and scapulohumeral rhythm, during shoulder analytical movements and during a functional task, will be measured by inertial sensors and described in degrees (°)
Baseline and one week after intervention
Change in movement quality through time variables
Time Frame: Baseline and one week after intervention
Movement quality will be assessed considering time to peak acceleration and task completion time, calculated according to the data recorded with inertial sensors
Baseline and one week after intervention
Change in movement quality through trunk compensation
Time Frame: Baseline and one week after intervention
Movement quality will be also assessed considering the trunk motion, calculated according to the data recorded with inertial sensors
Baseline and one week after intervention
Change in movement quality through smoothness
Time Frame: Baseline and one week after intervention
Smoothness will be calculated by jerk logarithm of data recorded with inertial sensors
Baseline and one week after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in muscle stiffness
Time Frame: Baseline and one week after intervention
Scapular muscles stiffness will be assessed by myotonometry (using a digital palpation device)
Baseline and one week after intervention
Change in pressure pain threshold
Time Frame: Baseline and one week after intervention
An assessment point in the shoulder area will be assessed by the application of a mechanical pressure by an algometer
Baseline and one week after intervention
Change in pain-related fear
Time Frame: Baseline and one week after intervention
Assessed with self-reported scales - Tampa Scale for Kinesiophobia, which ranges from 13 (best) to 52 (worst)
Baseline and one week after intervention
Change in pain catastrophization
Time Frame: Baseline and one week after intervention
Assessed with a self-reported scale - Pain Catastrophizing Scale, which ranges from 0 (better) to 52 (worst)
Baseline and one week after intervention
Self-impression of change
Time Frame: One week after intervention
The patient's individual perspective about his/her condition and changes felt considering the intervention received will be assessed by a self-reported scale - Patient global impression of change scale, which range from 0 [no change (or condition has got worse)] to 7 (a great deal better, and a considerable improvement that has made all the difference)
One week after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2023

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 28, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CE0108C
  • UIDB/05210/2020 (Other Grant/Funding Number: Fundação para a Ciência e Tecnologia, Portugal and EU)
  • SFRH/BD/140874/2018 (Other Grant/Funding Number: Fundação para a Ciência e Tecnologia (FCT), Portugal)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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