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NCT Number: NCT02702232

Shoulder Disorders in Patients With Parkinson's Disease

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.

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Key information

Conditions

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

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Ultrasonography

Other

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

Primary outcomes

  1. Functional examination for diagnosis

    Time frame: 1 year

    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.

  2. Ultrasound (US) examination for diagnosis

    Time frame: 1 year

    The patient will accept ultrasonography for shoulder joint for diagnosis

Secondary outcomes

  1. Range of motion

    Time frame: 1 year

    The range of motion will showed in degrees. The range of motion measurement will include shoulder abduction, shoulder flexion, external rotation and internal rotation.

  2. Pain

    Time frame: 1 year

    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.

  3. Disability

    Time frame: 1 year

    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).

Sponsors and collaborators

Lead sponsor

Shin Kong Wu Ho-Su Memorial Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 8, 2016
Registry last updated
Dec 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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