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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05814978
Other study ID # CE0108C
Secondary ID SFRH/BD/140874/2
Status Completed
Phase N/A
First received
Last updated
Start date March 27, 2023
Est. completion date August 31, 2023

Study information

Verified date January 2024
Source Polytechnic Institute of Porto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Experimental Scapular Therapeutic Exercise Group
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.

Locations

Country Name City State
Portugal Center for Rehabilitation Research, School of Health, Polytechnic of Porto Porto

Sponsors (6)

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

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Change in muscle stiffness Scapular muscles stiffness will be assessed by myotonometry (using a digital palpation device) Baseline and one week after intervention
Secondary 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 Baseline and one week after intervention
Secondary Change in pain-related fear Assessed with self-reported scales - Tampa Scale for Kinesiophobia, which ranges from 13 (best) to 52 (worst) Baseline and one week after intervention
Secondary Change in pain catastrophization Assessed with a self-reported scale - Pain Catastrophizing Scale, which ranges from 0 (better) to 52 (worst) Baseline and one week after intervention
Secondary 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) One week after intervention
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