NCT05814978

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

April 20, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

March 17, 2023

Last Update Submit

July 28, 2024

Conditions

Keywords

Shoulder painScapular musclesScapular kinematicsTherapeutic exercise

Outcome Measures

Primary Outcomes (8)

  • Change in shoulder pain

    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

    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

    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

    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

    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

    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

    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

    Smoothness will be calculated by jerk logarithm of data recorded with inertial sensors

    Baseline and one week after intervention

Secondary Outcomes (5)

  • Change in muscle stiffness

    Baseline and one week after intervention

  • Change in pressure pain threshold

    Baseline and one week after intervention

  • Change in pain-related fear

    Baseline and one week after intervention

  • Change in pain catastrophization

    Baseline and one week after intervention

  • Self-impression of change

    One week after intervention

Study Arms (1)

Experimental Scapular Therapeutic Exercise Group

EXPERIMENTAL

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

Other: Experimental Scapular Therapeutic Exercise Group

Interventions

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.

Experimental Scapular Therapeutic Exercise Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 65 years old

You may not qualify if:

  • Presenting scapular alterations as scapular dyskinesis (identified at rest or during motion)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Rehabilitation Research, School of Health, Polytechnic of Porto

Porto, 4200 - 072, Portugal

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ana Melo

    Polytechnic Institute of Porto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator - PhD grant student

Study Record Dates

First Submitted

March 17, 2023

First Posted

April 18, 2023

Study Start

April 20, 2023

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations