Acupuncture and Moxibustion for Motor Symptoms in Early Parkinson's Disease
ConditionParkinson's Disease (PD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-80
SponsorJiani Wu
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Diagnosed with Parkinson-plus syndromes or other secondary parkinsonism.
Prior history of deep brain stimulation (DBS) surgery.
Severe cerebrovascular disease, brain trauma, or history of craniotomy.
Severe dementia or psychiatric disorders that prevent cooperation with study procedures.
Trial design
Design model
Parallel
Treatments tested in this trial
Acupuncture and Moxibustion (AM)
Procedure/SurgeryAcupuncture 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 (Sham-AM)
Procedure/SurgerySham 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).
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Acupuncture and Moxibustion Group (AM)Experimental treatment 1 intervention
Group B: Sham Acupuncture and Moxibustion Group (Sham-AM)Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
The 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.Secondary outcomes
1
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 16.2
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 16.3
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 16.4
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.Other outcomes
1
The proportion of patients in intervention-related adverse events after 8-week treatment
Acupuncture-related adverse reactions include: severe acupuncture site pain (VAS \> 7), acupuncture site pain lasting more than 30 minutes, and local subcutaneous hematoma in the stimulated area. Moxibustion-related adverse reactions include: local redness and swelling, burns, and blistering. For medicines, please refer to the drug's instructions.
Time frame
evaluation time points: from baseline to the end of week 8.2
The proportion of patients with adherence ≥80%
Patient adherence is assessed using the treatment frequency count method to estimate the subjects' adherence. A good adherence criterion is defined as having received 80% or more of the scheduled treatments. Adherence is calculated by dividing the number of treatments received by the number of treatments expected, multiplied by 100%.
Time frame
evaluation time points: from baseline to the end of week 8.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jiani Wu
Lead sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor institution
Source ClinicalTrials.gov