- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05814978
Effects of Scapular Therapeutic Exercise on Essential Biomechanical and Neurophysiological Parameters in Shoulder Pain Conditions With Scapular Impairments
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Porto, Portugal, 4200 - 072
- Center for Rehabilitation Research, School of Health, Polytechnic of Porto
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
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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)
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Baseline and one week after intervention
|
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Change in shoulder function
Time Frame: Baseline and one week after intervention
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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
|
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Change in scapular muscles activity levels
Time Frame: Baseline and one week after intervention
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Scapular muscles activity levels, during shoulder analytical movements and during a functional task, will be recorded superficially by a wireless electromyographic signal detector system
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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
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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
|
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Change in movement quality through time variables
Time Frame: Baseline and one week after intervention
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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
|
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Change in movement quality through trunk compensation
Time Frame: Baseline and one week after intervention
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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
|
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Change in movement quality through smoothness
Time Frame: Baseline and one week after intervention
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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
|
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Change in pressure pain threshold
Time Frame: Baseline and one week after intervention
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An assessment point in the shoulder area will be assessed by the application of a mechanical pressure by an algometer
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Baseline and one week after intervention
|
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Change in pain-related fear
Time Frame: Baseline and one week after intervention
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Assessed with self-reported scales - Tampa Scale for Kinesiophobia, which ranges from 13 (best) to 52 (worst)
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Baseline and one week after intervention
|
|
Change in pain catastrophization
Time Frame: Baseline and one week after intervention
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Assessed with a self-reported scale - Pain Catastrophizing Scale, which ranges from 0 (better) to 52 (worst)
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Baseline and one week after intervention
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Self-impression of change
Time Frame: One week after intervention
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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)
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One week after intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ana Melo, Polytechnic Institute of Porto
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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