Clinical trial NCT06456840: Determination of Risk Factors of Shoulder Pathologies in Parkinson Disease
Official title: Determination of Risk Factors of Shoulder Pathologies in Parkinson Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Parkinson Disease
Shoulder Pain
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

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
* 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

1. Not defining pain with a score of 0 on the visual pain scale in both shoulders
2. Being over 50 years old
3. Being literate
4. Agreeing to participate in the study

Exclusion Criteria:

* 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
* 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)

Primary outcomes:
measure: USG FINDINGS
timeFrame: ONE MONTH
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sultan 2. Abdulhamid Han Training and Research Hospital
Study officials:
affiliation: SULTAN ABDÜLHAMIDHAN TRAINING AND RESEARCH HOSPITAL
name: MEHMET AKİF GÜLER, Ass. Prof.
role: STUDY_DIRECTOR
References: