This study evaluates the clinical effect and safety of acupuncture combined with moxibustion in improving motor symptoms of early-stage Parkinson's Disease (PD) patients, by assessing the changes in UPDRS scores. It also explores objective factors affecting the acupuncture effect and investigates the functional MRI mechanisms of acupuncture in PD treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Acupuncture and moxibustion group (AM): Acupuncture at Shuifen (CV9), bilateral Yinlingquan (SP9), bilateral Zhongliao (BL33), and bilateral Weiyang (BL39), combined with moxibustion at Shuifen (CV9) and Zhongliao (BL33).
Sham acupuncture and moxibustion group (sham-AM): Acupuncture at non-acuipoints of bilateral Hegu (LI4) and bilateral Zusanli (ST36), with fake moxibustion at Shuifen (CV9) and bilateral Zhongliao (BL33).
Guang'anmen Hospita, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGThe score change from baseline in the MDS-UPDRS part III after 8-week treatment
The MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) Part III assesses motor function in Parkinson's disease patients. It evaluates a range of motor symptoms, including tremor, rigidity, bradykinesia, postural instability, and gait. The scale is widely used to track disease progression and response to treatment. It consists of 26 items, scored based on the severity of each symptom.
Time frame: evaluation time points: baseline, week 8.
The score change from baseline in the MDS-UPDRS part III after 8-week follow-up
The MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) Part III assesses motor function in Parkinson's disease patients. It evaluates a range of motor symptoms, including tremor, rigidity, bradykinesia, postural instability, and gait. The scale is widely used to track disease progression and response to treatment. It consists of 26 items, scored based on the severity of each symptom.
Time frame: evaluation time points: baseline, week 16.
Changes in VAS scores of rigidity and bradykinesia after 8-week treatment and 8-week follow-up
The VAS range from 0-10, with higher score indicating more severe symptoms
Time frame: evaluation time points: baseline, week 8, week 16.
The score change from baseline in the MDS-UPDRS part II after 8-week treatment and 8-week follow-up
The MDS-UPDRS Part II evaluates the activities of daily living (ADL) in Parkinson's disease patients. It assesses how motor and non-motor symptoms impact daily functioning, including tasks such as dressing, eating, and walking. This section helps in understanding the patient's ability to perform everyday activities. It consists of 13 items, each scored based on the level of difficulty experienced.
Time frame: evaluation time points: baseline, week 8, week 16.
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The change from baseline in the MDS-UPDRS total score after 8-week treatment and 8-week follow-up
The MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) is a comprehensive tool used to assess the severity of Parkinson's disease symptoms. It is divided into four parts: motor examination (Part III), activities of daily living (Part II), non-motor experiences of daily living (Part I), and motor complications (Part IV). This scale helps in tracking disease progression, evaluating treatment efficacy, and improving clinical decision-making.
Time frame: evaluation time points: baseline, week 8, week 16.
The proportion of participants with ≥30% decrease of MDS-UPDRS Part III after 8-week treatment and 8-week follow-up
The MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) Part III assesses motor function in Parkinson's disease patients. It evaluates a range of motor symptoms, including tremor, rigidity, bradykinesia, postural instability, and gait. The scale is widely used to track disease progression and response to treatment. It consists of 26 items, scored based on the severity of each symptom.
Time frame: evaluation time points: baseline, week 8, week 16.
The change from baseline in PDQ-39 after 8-week treatment and 8-week follow-up
The PDQ-39 (Parkinson's Disease Questionnaire-39) is a patient-reported outcome measure used to assess the health-related quality of life in Parkinson's disease patients. It includes 39 items covering eight domains: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and sleep. Each item is scored based on the degree of difficulty or discomfort, and the results are summarized to provide an overall score. Higher scores indicate greater impairment in quality of life.
Time frame: evaluation time points: baseline, week 8, week 16.
The change from baseline in PDSS after 8-week treatment and 8-week follow-up
The Parkinson's Disease Sleep Scale (PDSS) is a tool used to assess sleep disturbances in Parkinson's disease patients. It consists of 15 items, covering sleep quality, nighttime symptoms, and daytime sleepiness. Each item is rated on a scale from 0 to 4, with higher scores indicating more severe sleep problems. The total score helps to evaluate the overall impact of sleep disturbances on the patient's quality of life.
Time frame: evaluation time points: baseline, week 8, week 16.
The change from baseline in SDS after 8-week treatment and 8-week follow-up
The Self-Rating Depression Scale (SDS) is a tool used to assess the severity of depressive symptoms. It consists of 20 items, each addressing mood, behavior, and physical symptoms related to depression. Each item is scored on a 4-point scale, ranging from "none" to "severe." Higher total scores indicate more severe depressive symptoms, helping to assess the patient's mental health status.
Time frame: evaluation time points: baseline, week 8, week 16.
The change from baseline in SAS after 8-week treatment and 8-week follow-up
The Self-Rating Anxiety Scale (SAS) is a tool used to assess the severity of anxiety symptoms. It consists of 20 items, which evaluate physical and psychological symptoms of anxiety. Each item is scored on a 4-point scale, from "none" to "severe." Higher total scores indicate greater levels of anxiety, helping to gauge the patient's emotional and mental state.
Time frame: evaluation time points: baseline, week 8, week 16.
The change from baseline in functional MRI signals after 8-week treatment.
The hospital's radiology department uses functional magnetic resonance imaging (fMRI) to measure and map brain activity by detecting changes in blood oxygen level-dependent (BOLD) signals in different brain regions.
Time frame: evaluation time points: baseline, week 8.
Subgroup analysis of gender in the score change from baseline in the MDS-UPDRS part III after 8-week treatment
Stratifying by gender into male and female subgroups, we assessed the difference in MDS-UPDRS Part III scores within each subgroup to compare the efficacy between men and women. The MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) Part III assesses motor function in Parkinson's disease patients. It evaluates a range of motor symptoms, including tremor, rigidity, bradykinesia, postural instability, and gait. The scale is widely used to track disease progression and response to treatment. It consists of 26 items, scored based on the severity of each symptom.
Time frame: evaluation time points: baseline, week 8.
Subgroup analysis of age in the score change from baseline in the MDS-UPDRS part III after 8-week treatment
Age stratification was performed by dividing participants into two subgroups: those younger than 60 years and those aged 60 and above. The difference in MDS-UPDRS Part III scores was assessed within each subgroup to compare the treatment efficacy between the two age subgroups. The MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) Part III assesses motor function in Parkinson's disease patients. It evaluates a range of motor symptoms, including tremor, rigidity, bradykinesia, postural instability, and gait. The scale is widely used to track disease progression and response to treatment. It consists of 26 items, scored based on the severity of each symptom.
Time frame: evaluation time points: baseline, week 8.
Subgroup analysis of disease severity in the score change from baseline in the MDS-UPDRS part III after 8-week treatment
Patients were stratified based on disease severity using the Hoehn and Yahr staging system into four subgroups: stage 1, 1.5, 2, and 2.5. The efficacy differences across disease stages were assessed by evaluating the change in MDS-UPDRS Part III scores within each subgroup. The difference in MDS-UPDRS Part III scores was assessed within each subgroup to compare the treatment efficacy between the two age subgroups. The MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) Part III assesses motor function in Parkinson's disease patients. It evaluates a range of motor symptoms, including tremor, rigidity, bradykinesia, postural instability, and gait. The scale is widely used to track disease progression and response to treatment. It consists of 26 items, scored based on the severity of each symptom.
Time frame: evaluation time points: baseline, week 8.