Determination of Risk Factors of Shoulder Pathologies in Parkinson Disease

NCT06456840 | Not Yet Recruiting

• 1 other identifier: 24277
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  ONE MONTH

Study Arms (4)

Group 1

40 Parkinson's patients who described pain in at least one shoulder (VAS\>3)

Diagnostic Test: ULTRASOUND

Group 2

0 Parkinson's patients with undefined pain in both shoulders (VAS: 0)

Diagnostic Test: ULTRASOUND

Group 3

40 patients of similar age and gender, without a Parkinson's diagnosis, with any shoulder pain (VAS\>3)

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)

Diagnostic Test: ULTRASOUND

Interventions

ULTRASOUND DIAGNOSTIC_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.

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 50 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

Sultan 2. Abdulhamid Han Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease; Shoulder Pain

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• MEHMET AKİF GÜLER, Ass. Prof.

  SULTAN ABDÜLHAMIDHAN TRAINING AND RESEARCH HOSPITAL

  STUDY DIRECTOR

Central Study Contacts

MÜRVET ARDA KÖROĞLU, MD

CONTACT

00905353251323; arda.murvet@gmail.com

EMRE ATA, Ass. Prof.

CONTACT

00905336152162; emreata.ftr@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 13, 2024
• Study Start: July 15, 2024
• Primary Completion: October 15, 2024
• Study Completion: December 30, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

TU (1)