Parkinson's DiseaseNCT02702232
Shoulder Disorders in Patients With Parkinson's Disease
An observational study of Parkinson's Disease and Shoulder Pain, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson's Disease, Shoulder Pain
- What is being tested?
- Ultrasonography
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2016to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients fulfilled the diagnosis of PD, as described by the United Kingdom Parkinson's Disease Society Brain Bank,
- Aged 50 to 80 years old.
Who cannot join
- Fracture or dislocation of the shoulder,
- Previous shoulder joint surgery,
- Severe medical comorbidities,
- Cognitive impairment (Mini-Mental Status Examination < 24).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Parkinson's Disease, Shoulder Pain
- Being tested
- Ultrasonography
- Medical subject headings
- Parkinson Disease, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyOther
Ultrasonography is applied for normal subjects and patients with Parkinson's disease
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Ultrasonography | |
| Normal | Normal controls who will be evaluated by ultrasonography for shoulder Receives: Other: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Ultrasound (US) examination for diagnosis
The patient will accept ultrasonography for shoulder joint for diagnosis
Measured: 1 year
Secondary outcomes (3)
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.
Measured: 1 year
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.
Measured: 1 year
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702232
- Sponsor's protocol ID
- 20150802R
- Other IDs
- SKH-8302-105-DR-25
- Status last verified
- Jan 2018
- First submitted
- 3 Feb 2016
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 35945122
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shoulder Disorders in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02702232
- Acronym / sponsor ID
- 20150802R
- Conditions
- Parkinson's Disease, Shoulder Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease | – | Other: UltrasonographyPatients 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. |
| Normal | – | Other: UltrasonographyNormal controls who will be evaluated by ultrasonography for shoulder |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients fulfilled the diagnosis of PD, as described by the United Kingdom Parkinson's Disease Society Brain Bank,
- Aged 50 to 80 years old.
Key exclusion criteria (4 listed)
- Fracture or dislocation of the shoulder,
- Previous shoulder joint surgery,
- Severe medical comorbidities,
- Cognitive impairment (Mini-Mental Status Examination < 24).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasonographyUltrasonography is applied for normal subjects and patients with Parkinson's disease | Other | Normal, Parkinson's disease |
Primary outcome
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.
Ultrasound (US) examination for diagnosis
Time frame: 1 year
The patient will accept ultrasonography for shoulder joint for diagnosis
3 secondary outcomes
Range of motion
Time frame: 1 year
Pain
Time frame: 1 year
Disability
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Derived from this study: PubMed 35945122Hsieh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Shoulder Pain, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional examination for diagnosis (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02702232, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.