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

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Primary Purpose

Status

Enrolling by invitation

Phase

Not Applicable

Locations

Portugal

Study Type

Interventional

Intervention

Experimental Scapular Therapeutic Exercise Group

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Shoulder pain, Scapular muscles, Scapular kinematics, Therapeutic exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Scapular Therapeutic Exercise Group

Arm Description

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

Outcomes

Primary Outcome Measures

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)

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).

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

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.

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 (°)

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

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

Change in movement quality through smoothness

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

Secondary Outcome Measures

Change in muscle stiffness

Scapular muscles stiffness will be assessed by myotonometry (using a digital palpation device)

Change in pressure pain threshold

An assessment point in the shoulder area will be assessed by the application of a mechanical pressure by an algometer

Change in pain-related fear

Assessed with self-reported scales - Tampa Scale for Kinesiophobia, which ranges from 13 (best) to 52 (worst)

Change in pain catastrophization

Assessed with a self-reported scale - Pain Catastrophizing Scale, which ranges from 0 (better) to 52 (worst)

Self-impression of change

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)

Full Information

NCT ID

NCT05814978

First Posted

March 17, 2023

Last Updated

April 17, 2023

Sponsor

Polytechnic Institute of Porto

Collaborators

School of Health of Polytechnic Institute of Porto, Center for Rehabilitation Research - Human Movement System (Re)habilitation Area, Universidade do Porto, Porto Biomechanics Laboratory, Center for Interdisciplinary Applied Research in Health, Health School of the Setubal, Polytechnic Institute

1. Study Identification

Unique Protocol Identification Number

NCT05814978

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

March 27, 2023 (Actual)

Primary Completion Date

July 2023 (Anticipated)

Study Completion Date

July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Polytechnic Institute of Porto

Collaborators

School of Health of Polytechnic Institute of Porto, Center for Rehabilitation Research - Human Movement System (Re)habilitation Area, Universidade do Porto, Porto Biomechanics Laboratory, Center for Interdisciplinary Applied Research in Health, Health School of the Setubal, Polytechnic Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder Pain

Keywords

Shoulder pain, Scapular muscles, Scapular kinematics, Therapeutic exercise

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental Scapular Therapeutic Exercise Group

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Experimental Scapular Therapeutic Exercise Group

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in shoulder pain

Description

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)

Time Frame

Baseline and one week after intervention

Title

Change in shoulder function

Description

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).

Time Frame

Baseline and one week after intervention

Title

Change in scapular muscles activity levels

Description

Scapular muscles activity levels, during shoulder analytical movements and during a functional task, will be recorded superficially by a wireless electromyographic signal detector system

Time Frame

Baseline and one week after intervention

Title

Change in scapular muscles ratio

Description

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.

Time Frame

Baseline and one week after intervention

Title

Change in kinematics

Description

Scapular kinematics and scapulohumeral rhythm, during shoulder analytical movements and during a functional task, will be measured by inertial sensors and described in degrees (°)

Time Frame

Baseline and one week after intervention

Title

Change in movement quality through time variables

Description

Movement quality will be assessed considering time to peak acceleration and task completion time, calculated according to the data recorded with inertial sensors

Time Frame

Baseline and one week after intervention

Title

Change in movement quality through trunk compensation

Description

Movement quality will be also assessed considering the trunk motion, calculated according to the data recorded with inertial sensors

Time Frame

Baseline and one week after intervention

Title

Change in movement quality through smoothness

Description

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

Time Frame

Baseline and one week after intervention

Secondary Outcome Measure Information:

Title

Change in muscle stiffness

Description

Scapular muscles stiffness will be assessed by myotonometry (using a digital palpation device)

Time Frame

Baseline and one week after intervention

Title

Change in pressure pain threshold

Description

An assessment point in the shoulder area will be assessed by the application of a mechanical pressure by an algometer

Time Frame

Baseline and one week after intervention

Title

Change in pain-related fear

Description

Assessed with self-reported scales - Tampa Scale for Kinesiophobia, which ranges from 13 (best) to 52 (worst)

Time Frame

Baseline and one week after intervention

Title

Change in pain catastrophization

Description

Assessed with a self-reported scale - Pain Catastrophizing Scale, which ranges from 0 (better) to 52 (worst)

Time Frame

Baseline and one week after intervention

Title

Self-impression of change

Description

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)

Time Frame

One week after intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ana Melo

Organizational Affiliation

Polytechnic Institute of Porto

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Porto

ZIP/Postal Code

4200 - 072

Country

Portugal

12. IPD Sharing Statement

Plan to Share IPD

No

Shoulder Pain

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial