Parkinson DiseaseNCT06456840
Determination of Risk Factors of Shoulder Pathologies in Parkinson Disease
An observational study of Parkinson Disease and Shoulder Pain, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
Parkinson's disease was first described in history in 1817 by James Parkinson in his monograph "An essay on swinging palsy", and today it is the 2nd most common neurodegenerative disease after Alzheimer's, affecting approximately 6.1 million people. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Shoulder Pain
- What is being tested?
- ULTRASOUND
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2024to 30 Dec 2024
- Phase
- Observational
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will be carried out cross-sectionally and in a single center, with patients diagnosed with Parkinson's disease who apply to the Physical Medicine and Rehabilitation Polyclinic of the University of Health Sciences Sultan 2.Abdülhamid Han Training and Research Hospital, and healthy volunteers who describe pain in any shoulder and who do not describe pain in any shoulder. The number of samples was calculated with G-power.Total of 160 patients and 320 shoulders were calculated.
Who may be able to join
- Group1
- Being diagnosed with Parkinson's according to the Movement Disorders Society diagnostic criteria
- Being over 50 years old
- Being in the Hoehn \& Yahr stage I-IV range
- Identification of pain in at least one shoulder (VAS>3)
- Agreeing to participate in the study
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- Being literate
- Group2
- Being diagnosed with Parkinson's according to the Movement Disorders Society diagnostic criteria
- Being over 50 years old
- Being in the Hoehn \& Yahr stage I-IV range
- No pain in both shoulders (VAS: 0)
- Agreeing to participate in the study
- Being literate
- Group 3
- Describe pain >3 on the visual pain scale in any shoulder
- Being over 50 years old
- Becoming literate
- Agreeing to participate in the study
- Group 4
- Not defining pain with a score of 0 on the visual pain scale in both shoulders
- Being over 50 years old
- Being literate
- Agreeing to participate in the study
Who cannot join
- Scoring less than 24 points in the Mini Mental Test
- Having had a myocardial infarction
- Having had a cerebrovascular accident
- Having a rheumatological disease
- Known endocrine disease (Diabetes Mellitus, Hypo/hyperthyroidism)
- Cervical disc herniation defining radiculopathy
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- Active trigger point palpated in the shoulder girdle muscles
- Having had any shoulder surgery
- Concomitant history of active systemic inflammatory disease, active infection and active malignancy
- Physical Therapy modalities have been applied in the last 6 months
- Having had an interventional procedure performed on the shoulder area within the last 6 months
- Using medications that may cause tendinopathy (Fluoroquinolines)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultan 2. Abdulhamid Han Training and Research Hospital
Istanbul
emre ata, md, 05336152162, emreata.ftr@gmail.com
About this study
Parkinson's disease was first described in history in 1817 by James Parkinson in his monograph "An essay on swinging palsy", and today it is the 2nd most common neurodegenerative disease after Alzheimer's, affecting approximately 6.1 million people. Its main histopathological feature is the decrease in dopaminergic secretion in the basal ganglia and there are three cardinal findings: Bradykinesia, Tremor, Rigidity. Although joint and skeletal deformities are seen in approximately 70% of Parkinson's patients, they are not adequately evaluated and cause significant functional disability and chronic pain, independent of motor symptoms.Musculoskeletal pathologies seen in Parkinson's patients can be classified as: musculoskeletal pain, articular problems, postural problems and bone mineralization defects. The shoulder girdle is a joint with complex and delicate function, consisting of four joints (glenohumeral, sternoclavicular, acromioclavicular and scapulothoracic), supporting muscles and periarticular ligaments, which seriously affects the patient's quality of daily life and function. Although magnetic resonance imaging (MRI) is the best imaging tool in the diagnosis of musculoskeletal system pathologies, it is quite sensitive to artifact-forming motion. Ultrasound (US) imaging is widely used in the evaluation of rotator cuff muscles, biceps muscle and glenohumeral joint pathologies and has many advantages over MRI, such as providing fast, cheap and dynamic imaging. Although many studies have proven that shoulder girdle musculoskeletal pathologies such as bicipital tendinitis, m.supraspinatus tendinosis, subacromial/subdeltoid bursitis, subacromial impingement syndrome, and adhesive capsulitis are seen more frequently in Parkinson's patients by ultrasonographic imaging, these shoulder girdle pathologies seen in Parkinson's patients are more common. The risk factors for pathologies have not been defined. In this study, we aimed to determine the ultrasonographic findings and risk factors of shoulder pathologies in Parkinson's patients and to investigate the effects of shoulder pathologies on quality of daily life, physical activity, falls and balance.
- Conditions
- Parkinson Disease, Shoulder Pain
- Being tested
- ULTRASOUND
- Medical subject headings
- Parkinson Disease, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ULTRASOUNDDiagnostic test
Measurements will be made in musculoskeletal system ultrasonography by an international Medicine and Rehabilitation assistant physician using images obtained with the Sonosite M-Turbo device using the ImageJ program. During the measurements, the patient and the patient will be face to face and the device will be placed postero-laterally. Five standard window spacings will be used for the shoulder attachment. These are: anterior transverse, anterior longitudinal, lateral longitudinal, lateral transverse, posterior transverse.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 40 Parkinson's patients who described pain in at least one shoulder (VAS>3) Receives: Diagnostic Test: ULTRASOUND | |
| Group 2 | 0 Parkinson's patients with undefined pain in both shoulders (VAS: 0) Receives: Diagnostic Test: ULTRASOUND | |
| Group 3 | 40 patients of similar age and gender, without a Parkinson's diagnosis, with any shoulder pain (VAS>3) Receives: Diagnostic Test: ULTRASOUND | |
| Group 4 | 40 patients of similar age and gender, diagnosed without Parkinson's disease and without pain in both shoulders (VAS: 0) Receives: Diagnostic Test: ULTRASOUND |
What is being measured
The primary outcome is the main question the study is designed to answer.
USG FINDINGS
Measurements will be made by a Physical Medicine and Rehabilitation assistant physician experienced in musculoskeletal system ultrasonography, using the images obtained with the Sonosite M-Turbo device using the ImageJ program. During the measurements, the device will be positioned on the postero-lateral side of the patient while the patient and the practitioner are face to face. Five standard viewing windows will be used for the shoulder joint. These are: anterior transverse, anterior longitudinal, lateral longitudinal, lateral transverse, posterior transverse.
Measured: ONE MONTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start15 Jul 2024 (estimated)
- Primary completion15 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MEHMET AKİF GÜLER, Ass. Prof., Study director, SULTAN ABDÜLHAMIDHAN TRAINING AND RESEARCH HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456840
- Sponsor's protocol ID
- 24277
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Risk Factors of Shoulder Pathologies in Parkinson Disease
- ClinicalTrials.gov ID
- NCT06456840
- Acronym / sponsor ID
- 24277
- Conditions
- Parkinson Disease, Shoulder Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 13 Jun 2024 (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.
Parkinson's disease was first described in history in 1817 by James Parkinson in his monograph "An essay on swinging palsy", and today it is the 2nd most common neurodegenerative disease after Alzheimer's, affecting approximately 6.1 million people. Its main histopathological feature is the decrease in dopaminergic secretion in the basal ganglia and there are three cardinal findings: Bradykinesia, Tremor, Rigidity. Although joint and skeletal deformities are seen in approximately 70% of Parkinson's patients, they are not adequately evaluated and cause significant functional disability and chronic pain, independent of motor symptoms.Musculoskeletal pathologies seen in Parkinson's patients can be classified as: musculoskeletal pain, articular problems, postural problems and bone mineralization defects. The shoulder girdle is a joint with complex and delicate function, consisting of four joints (glenohumeral, sternoclavicular, acromioclavicular and scapulothoracic), supporting muscles and periarticular ligaments, which seriously affects the patient's quality of daily life and function. Although magnetic resonance imaging (MRI) is the best imaging tool in the diagnosis of musculoskeletal system pathologies, it is quite sensitive to artifact-forming motion. Ultrasound (US) imaging is widely used in the evaluation of rotator cuff muscles, biceps muscle and glenohumeral joint pathologies and has many advantages over MRI, such as providing fast, cheap and dynamic imaging. Although many studies have proven that shoulder girdle musculoskeletal pathologies such as bicipital tendinitis, m.supraspinatus tendinosis, subacromial/subdeltoid bursitis, subacromial impingement syndrome, and adhesive capsulitis are seen more frequently in Parkinson's patients by ultrasonographic imaging, these shoulder girdle pathologies seen in Parkinson's patients are more common. The risk factors for pathologies have not been defined. In this study, we aimed to determine the ultrasonographic findings and risk factors of shoulder pathologies in Parkinson's patients and to investigate the effects of shoulder pathologies on quality of daily life, physical activity, falls and balance.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: ULTRASOUND40 Parkinson's patients who described pain in at least one shoulder (VAS>3) |
| Group 2 | – | Diagnostic Test: ULTRASOUND0 Parkinson's patients with undefined pain in both shoulders (VAS: 0) |
| Group 3 | – | Diagnostic Test: ULTRASOUND40 patients of similar age and gender, without a Parkinson's diagnosis, with any shoulder pain (VAS>3) |
| Group 4 | – | Diagnostic Test: ULTRASOUND40 patients of similar age and gender, diagnosed without Parkinson's disease and without pain in both shoulders (VAS: 0) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be carried out cross-sectionally and in a single center, with patients diagnosed with Parkinson's disease who apply to the Physical Medicine and Rehabilitation Polyclinic of the University of Health Sciences Sultan 2.Abdülhamid Han Training and Research Hospital, and healthy volunteers who describe pain in any shoulder and who do not describe pain in any shoulder. The number of samples was calculated with G-power.Total of 160 patients and 320 shoulders were calculated.
Key inclusion criteria (24 listed)
- Group1
- Being diagnosed with Parkinson's according to the Movement Disorders Society diagnostic criteria
- Being over 50 years old
- Being in the Hoehn \& Yahr stage I-IV range
- Identification of pain in at least one shoulder (VAS>3)
Key exclusion criteria (12 listed)
- Scoring less than 24 points in the Mini Mental Test
- Having had a myocardial infarction
- Having had a cerebrovascular accident
- Having a rheumatological disease
- Known endocrine disease (Diabetes Mellitus, Hypo/hyperthyroidism)
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 |
|---|---|---|
| ULTRASOUNDMeasurements will be made in musculoskeletal system ultrasonography by an international Medicine and Rehabilitation assistant physician using images obtained with the Sonosite M-Turbo device using the ImageJ program. During the measurements, the patient and the patient will be face to face and the device will be placed postero-laterally. Five standard window spacings will be used for the shoulder attachment. These are: anterior transverse, anterior longitudinal, lateral longitudinal, lateral transverse, posterior transverse. | Diagnostic test | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
USG FINDINGS
Time frame: ONE MONTH
Measurements will be made by a Physical Medicine and Rehabilitation assistant physician experienced in musculoskeletal system ultrasonography, using the images obtained with the Sonosite M-Turbo device using the ImageJ program. During the measurements, the device will be positioned on the postero-lateral side of the patient while the patient and the practitioner are face to face. Five standard viewing windows will be used for the shoulder joint. These are: anterior transverse, anterior longitudinal, lateral longitudinal, lateral transverse, posterior transverse.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
MEHMET AKİF GÜLER, Ass. Prof. study director
SULTAN ABDÜLHAMIDHAN TRAINING AND RESEARCH HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Shoulder Pain, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
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 24 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 13 Jun 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MÜRVET ARDA KÖROĞLU, MD (00905353251323, arda.murvet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
USG FINDINGS (time frame: ONE MONTH). 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 13 Jun 2024.