Shoulder PainNCT05814978
Effects of Scapular Therapeutic Exercise on Essential Biomechanical and Neurophysiological Parameters in Shoulder Pain Conditions With Scapular Impairments
A study testing Experimental Scapular Therapeutic Exercise Group in people with Shoulder Pain, run by Polytechnic Institute of Porto at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Experimental Scapular Therapeutic Exercise Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePortugal
- Study dates
- 20 Apr 2023to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Center for Rehabilitation Research, School of Health, Polytechnic of Porto
Porto, 4200 - 072
About this study
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.
Read the detailed description
The study only started after approval of the protocol
- Conditions
- Shoulder Pain
- Being tested
- Experimental Scapular Therapeutic Exercise Group
- Keywords
- Shoulder pain, Scapular muscles, Scapular kinematics, Therapeutic exercise
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Scapular Therapeutic Exercise GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Experimental Scapular Therapeutic Exercise Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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 (°)
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and one week after intervention
Secondary outcomes (5)
Change in muscle stiffness
Scapular muscles stiffness will be assessed by myotonometry (using a digital palpation device)
Measured: Baseline and one week after intervention
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
Measured: Baseline and one week after intervention
Change in pain-related fear
Assessed with self-reported scales - Tampa Scale for Kinesiophobia, which ranges from 13 (best) to 52 (worst)
Measured: Baseline and one week after intervention
Change in pain catastrophization
Assessed with a self-reported scale - Pain Catastrophizing Scale, which ranges from 0 (better) to 52 (worst)
Measured: Baseline and one week after intervention
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)
Measured: One week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start20 Apr 2023
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polytechnic Institute of Porto
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Ana Melo, Polytechnic Institute of Porto
- Investigators
- Ana Melo, Principal investigator, Polytechnic Institute of Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814978
- Sponsor's protocol ID
- CE0108C
- Other IDs
- SFRH/BD/140874/2018, UIDB/05210/2020
- Status last verified
- Jul 2024
- First submitted
- 17 Mar 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Scapular Therapeutic Exercise on Essential Biomechanical and Neurophysiological Parameters in Shoulder Pain Conditions With Scapular Impairments
- ClinicalTrials.gov ID
- NCT05814978
- Acronym / sponsor ID
- CE0108C
- Conditions
- Shoulder Pain
- Keywords
- Shoulder pain, Scapular muscles, Scapular kinematics, Therapeutic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Polytechnic Institute of PortoUniversity, hospital or other
- 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
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study only started after approval of the protocol
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Scapular Therapeutic Exercise Group | Experimental | Other: Experimental Scapular Therapeutic Exercise GroupPatients 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Scapular Therapeutic Exercise GroupAll 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. | Other | Experimental Scapular Therapeutic Exercise Group |
Primary outcome
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)
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).
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
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.
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 (°)
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
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
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
5 secondary outcomes
Change in muscle stiffness
Time frame: Baseline and one week after intervention
Change in pressure pain threshold
Time frame: Baseline and one week after intervention
Change in pain-related fear
Time frame: Baseline and one week after intervention
Change in pain catastrophization
Time frame: Baseline and one week after intervention
Self-impression of change
Time frame: One week after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Melo principal investigator
Polytechnic Institute of Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Scapular Therapeutic Exercise Group in people with Shoulder Pain, run by Polytechnic Institute of Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in shoulder pain (time frame: Baseline and one week after intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.