NCT02702232

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

December 23, 2020

Status Verified

January 1, 2018

Enrollment Period

1.9 years

First QC Date

February 3, 2016

Last Update Submit

December 22, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • Ultrasound (US) examination for diagnosis

    The patient will accept ultrasonography for shoulder joint for diagnosis

    1 year

Secondary Outcomes (3)

  • Range of motion

    1 year

  • Pain

    1 year

  • Disability

    1 year

Study Arms (2)

Parkinson's disease

Patients with PD will be recruited consecutively from a neurology clinic. A group of sex- and age-matched normal subjects with be recruited from the public. These patients will be evaluated by ultrasonography for shoulder.

Other: Ultrasonography

Normal

Normal controls who will be evaluated by ultrasonography for shoulder

Other: Ultrasonography

Interventions

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

NormalParkinson's disease

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with PD will be recruited consecutively from a neurology clinic. A group of sex- and age-matched normal subjects with be recruited from the public.

You may qualify if:

  • Patients fulfilled the diagnosis of PD, as described by the United Kingdom Parkinson's Disease Society Brain Bank,
  • Aged 50 to 80 years old.

You may not qualify if:

  • Fracture or dislocation of the shoulder,
  • Previous shoulder joint surgery,
  • Severe medical comorbidities,
  • Cognitive impairment (Mini-Mental Status Examination \< 24).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

Related Publications (1)

  • Hsieh LF, Kuo YC, Lin YT, Liu YF, Wang HC. Ultrasonographic imaging findings of the shoulder in patients with Parkinson disease. J Orthop Sci. 2023 Sep;28(5):1004-1010. doi: 10.1016/j.jos.2022.07.001. Epub 2022 Aug 6.

MeSH Terms

Conditions

Parkinson DiseaseShoulder Pain

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2016

First Posted

March 8, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

December 23, 2020

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations