Effect of Electroacupuncture on Symptoms of Female Pelvic Organ Prolapse(Level II - III)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pelvic Organ Prolapse
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients who sign the informed consent form and are eligible for the study entry at week 0 will be randomized to one of the two groups: electroacupuncture group and sham electroacupuncture group. The two groups will be assessed in a paralleled manner, and patients in both groups will be treated for 24 times in 3 months(3 times weekly for 4 weeks, 2 times weekly for 4 weeks and once every week for 4 weeks) and followed up for 6 months after treatment.Masking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: The participants, investigator and outcome assessor will be masked. The care provider cannot be masked, but will be different person from investigator and outcome assessor.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 35 years and 125 years
- Gender
- Only males
Description
After being informed about the study and potential risk, all patients giving written informed consent form will be undergo a 1-week screening period to determine eligibility for study entry. Eligible patients will be randomly assigned to one of the two groups 1) electroacupuncture group: electroacup...
After being informed about the study and potential risk, all patients giving written informed consent form will be undergo a 1-week screening period to determine eligibility for study entry. Eligible patients will be randomly assigned to one of the two groups 1) electroacupuncture group: electroacupuncture will be provided to patients at BL33, BL35 and SP6 for 3 time per week for the first 4 weeks, then twice a week for 4 weeks, and once a week for the last 4 weeks. There will be 24 times of treatment in total in 3 month; 2) sham electroacupuncture group: sham electroacupuncture will be provided to patients at sham acupoints to BL33, BL35 and SP6 with the same schedule as electroacupuncture group.The follow-up time for the two groups are 6 months after treatment. Primary and secondary outcome will be measured at 3, 6, and 9 months from the start of the treatment, respectively.
Tracking Information
- NCT #
- NCT04589715
- Collaborators
- Shaanxi Hospital of Traditional Chinese Medicine
- Hunan University of Traditional Chinese Medicine
- Lianyungang City Hospital of Traditional Chinese Medicine
- Jiangsu Second Hospital of Traditional Chinese Medicine
- Shenzhen Second People's Hospital
- Investigators
- Principal Investigator: Zhishun Liu, PhD,MD Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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