Effectiveness of pharmacopuncture for improving pain in Parkinson’s disease : Pragmatic randomized, assessor blinded, controlled clinical trial
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0007254
- Lead Sponsor
- Kyung Hee University Oriental Medicine Hospital at Gangdong
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 150
Patients with Parkinson disease
(1)Adult patients aged =19 years
(2)Diagnosis of idiopathic PD based on UK Parkinson’s Diseases Society Brain Bank criteria
(3)Hoehn and Yahr Scale stage 1–4
(4)King’s Parkinson’s Disease Pain Scale > 0
(5)A stable dose of conventional treatment for at least 4 weeks prior to enrollment
(6)Terminated PA or MA treatment 4 weeks before enrollment
(7)Provide voluntary written informed consent to participate in this clinical study
Healthy control
(1)Adult patients aged =19 years
(2)Undiagnosis of idiopathic PD based on UK Parkinson’s Diseases Society Brain Bank criteria
(3)No functional/substrate diseases and clinically meaningful findings in medical history investigation and physical examination
(4)King’s Parkinson’s Disease Pain Scale = 0
(5) Provide voluntary written informed consent to participate in this clinical study
Patient with Parkinson's disease
(1)Parkinson-plus syndromes (i.e., multisystem atrophy, progressive supranuclear palsy, corticobasal degeneration, dementia with Lewy bodies)
(2)Pain unrelated to PD (i.e., postoperative pain)
(3)History of neuropsychiatric disorder unrelated to PD
(4)Moderate or higher cognitive impairment that will interfere with the evaluation of treatment effects
(5)Severe acute cardiovascular disease (i.e., heart failure, myocardial infarction, stroke, hypertension)
(6)Serious conditions (i.e., anemia, active pulmonary tuberculosis, thyroid disease, and other infectious and systemic diseases)
(7)Active cancer
(8)Uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure >100 mmHg)
(9)History of hypersensitivity reactions to the PA
(10) Inappropriate or unsafe PA treatment (i.e., hemorrhagic disease, severe diabetes patients who have higher risk of infection)
(11) History of oral adrenal corticosteroids (steroids), immunosuppressants, or antipsychotic drug or other drugs that may affect clinical trial results within the last 4 weeks
(12) Inability to undergo MRI.
(13) Pregnant or lactating women or current contraceptive use among women of pregnant potential who are likely to become pregnant (except for women who have undergone sterilization)
(14) History of drug or alcohol abuse
(15) Unstable medical condition as decided by the research clinician
(16) Participation in another clinical trial within the last 4 weeks
(17) History of vaccination within 4 weeks or plans to be vaccinated during the clinical trial period
(18) Inappropriate for enrollment due to other reasons as determined by the investigator
Healthy control
(1)Pain complaint
(2)History of neuropsychiatric disorder
(3)Moderate or higher cognitive impairment that will interfere with the evaluation of treatment effects
(4)Severe acute cardiovascular disease (i.e., heart failure, myocardial infarction, stroke, hypertension)
(5)Serious conditions (i.e., anemia, active pulmonary tuberculosis, thyroid disease, and other infectious and systemic diseases)
(6)Active cancer
(7)Uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure >100 mmHg)
(8) History of oral adrenal corticosteroids (steroids), immunosuppressants, or antipsychotic drug or other drugs that may affect clinical trial results within the last 4 weeks
(9) Inability to undergo MRI.
(10) Pregnant or lactating women or current contraceptive use among women of pregnant potential who are likely to become pregnant (except for women who have undergone sterilization)
(11) History of drug or alcohol abuse
(12) Unstable medical condition as decided by the research clinician
(13) Participation in another clinical trial within the last 4 weeks
(14) History of vaccination within 4 weeks or plans to be vaccinated during the clinical trial period
(15) Inappropriate for enrollment due to other reasons as determined by the investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method King’s Parkinson’s Disease Pain Scale
- Secondary Outcome Measures
Name Time Method umeral rating scale ;Unified Parkinson’s Disease Rating Scale II, III ;Beck Depression Inventory II ;Beck Anxiety Inventory ;Pain Catastrophizing score;Euro-Quality of Life-5 Dimension;Parkinson’s disease Sleep Scale -2;King’s Parkinson’s Disease Pain Scale ;Magnetic resonance imaging;Molecular analysis;Pattern identification Questionnaire;Gait analysis;Assessment of facial expressions in response to emotion-eliciting stimuli