Shoulder Disorders in Patients With Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Shoulder Disorders in Patients With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702232
• Other study ID #: 20150802R
• Secondary ID: SKH-8302-105-DR-
• Status: Completed
• Start date: January 2016
• Est. completion date: January 2018

Study information

• Verified date: January 2018
• Source: Shin Kong Wu Ho-Su Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Parkinson's disease (PD) is a multisystem neurodegenerative disorder that is increasingly recognized in our ageing population. It is characterized by cardinal clinical features including bradykinesia, tremor, rigidity, and postural instability. For most people with PD, the most serious concern is with the motor system: stiffness, slowness of movement, impaired handwriting and coordination, poor mobility and balance. However, more than half of all people with PD have experienced painful symptoms. Most people experience aching, stiffness, numbness and tingling at some point in the course of the illness. Defazio et al reported that pain may begin at clinical onset of PD or thereafter as a non-motor feature of PD.5 Aching muscles and joints are especially common in PD. Rigidity, lack of spontaneous movement, abnormalities of posture and awkward mechanical stresses all contribute to musculoskeletal pain in PD.

Description:

One of the most common musculoskeletal complaints is shoulder pain or shoulder disorders, including frozen shoulder, bursitis, and rotator cuff lesions. Actually, shoulder pain or shoulder disorder can be the first sign of PD. The prevalence and severity of shoulder disorders in Parkinson's disease are not totally clear. In a retrospective study, Stamey found shoulder pain was present in 11% of patients with PD.

Over the past ten years ultrasound (US) has become popular in the evaluation of shoulder disorders. It allows for the detailed assessment of a wide range of changes involving different anatomic structures of the shoulder joint, including rotator cuffs, biceps tendon, and subdeltoid bursa. Koh et al found among 33 PD patients, 22 patients had abnormal US findings on the dominant side, and all 22 patients with abnormal US finding had a tendon tear and 9 patients had frozen shoulder. However, there were no control group in Koh' s study, and diagnosis of frozen shoulder with US findings is still controversial.

The purposes of this study are to evaluate patients with PD with a combination of physical examination and US study of the shoulder, and to compare the frequency and type of shoulder lesion in US between patients with PD and normal subjects. The investigators also plan to test the correlation between shoulder disorders or US abnormality and the severity of PD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients fulfilled the diagnosis of PD, as described by the United Kingdom Parkinson's Disease Society Brain Bank,

• Aged 50 to 80 years old.

Exclusion Criteria:

• Fracture or dislocation of the shoulder,

• Previous shoulder joint surgery,

• Severe medical comorbidities,

• Cognitive impairment (Mini-Mental Status Examination < 24).

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease
• Shoulder Pain

Intervention

Other:
• Ultrasonography
Ultrasonography is applied for normal subjects and patients with Parkinson's disease

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Shin Kong Wu Ho-Su Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional examination for diagnosis	The patient will received Cyriax's functional examination for shoulder joint to make a clinical diagnosis. It included three arm elevation, three tests for glenohumeral joints, and six resisted tests.	1 year
Primary	Ultrasound (US) examination for diagnosis	The patient will accept ultrasonography for shoulder joint for diagnosis	1 year
Secondary	Range of motion	The range of motion will showed in degrees. The range of motion measurement will include shoulder abduction, shoulder flexion, external rotation and internal rotation.	1 year
Secondary	Pain	The VAS scores were obtained using a horizontal lines of 100 mm, with 0 on the left indicating no pain and 100 on the right indicating very severe pain. A VAS has been shown to be reliable and sensitive for quantifying pain, with test-retest reliability of >0.90.19 In previous studies of patients treated for various shoulder disorders, the responsiveness of VAS for pain was moderate to good.	1 year
Secondary	Disability	The SPADI is a self-administered questionnaire to assess the pain and disability associated with shoulder disease. The total SPADI score is ranges between 0 and 100. The SDQ is a symptoms in patients with shoulder disorders. The final score is obtained by dividing the number by 100, which results in a final score ranging between 0 (no disability) and 100 (the worst situation).	1 year