Different Modes of Assessment on Acupuncture Effect on Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome

NCT ID: NCT03641807

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2021-10-30

Brief Summary

Background: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common disorder. Some studies have indicated that acupuncture may ameliorate the symptoms of CP/CPPS. However, results are varied and range widely, perhaps due to different modes of assessment including timepoints, places of assessment, and especially subjective scales. We propose to determine the efficacy of acupuncture relative to sham acupuncture for patients with CP/CPPS, and compare different modes of assessment regarding the therapeutic effects of acupuncture.

Methods: Sixty patients with CP/CPPS will be randomly assigned to receive either acupuncture or sham-acupuncture (30 patients, each). Treatment will be conducted 3 times/week, for 4 weeks. The primary outcomes will each be the change from baseline of the total NIH (National Institutes of Health) CPSI (Chronic Prostatitis Symptom Index) score associated with 3 modes of assessment: Mode 1, the scale recorded at the hospital within 10minutes after the last session of 4 weeks of acupuncture treatment, in the company of the outcome assessors; Mode 2, the scale recorded the same day, but not at the hospital; and Mode 3, the scale recorded at the hospital 1 to 3 days after the last acupuncture session. The 3 key secondary outcomes include will be the 3 modes assessment of the changes from baseline of the NIH-CPSI total scores in the acupuncture group at week 4 after treatment. Analysis was by intention-to-treat, and multiplicity was controlled for with a step-down closed-testing procedure.

Conditions

Chronic Prostatitis; Chronic Pelvic Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Acupuncture

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

Bilateral BL23, BL33, BL35 and SP6 will be inserted using Hwato-brand disposable acupuncture needles. With patients prone, after routine sterilization, bilateralBL33 will be inserted to a depth of 50 to 60mm with a 30° to 45° angle in an inferomedial direction using needles (0.30mm in diameter, 75mm in length). Bilateral BL35 will be inserted to a depth of 50 to 60mm with a slightly superolateral direction using needles (0.30mm in diameter, 75mm in length). BL23 and SP6 will be inserted vertically to a depth of 25 to 30mm using needles (0.30mm in diameter, 40mm in length). Manipulation of the needles by lifting and thrusting combined with twirling and rotating evenly will be performed until deqi occurs, defined as a sensation of soreness, numbness, heaviness, and ache. Manipulations will be applied every 10minutes and each session will last for 30minutes.

Sham acupuncture

Group Type: SHAM_COMPARATOR

Sham acupuncture

Intervention Type: OTHER

Bilateral sham BL 23, BL 33, BL 35 (15mmto BL23, BL33, and BL35) and SP6 (10mmto SP6) will be inserted by needles (0.20mm in diameter, 25mm in length) to a depth of 2 to 3mm without manipulation.

Interventions

Acupuncture

Bilateral BL23, BL33, BL35 and SP6 will be inserted using Hwato-brand disposable acupuncture needles. With patients prone, after routine sterilization, bilateralBL33 will be inserted to a depth of 50 to 60mm with a 30° to 45° angle in an inferomedial direction using needles (0.30mm in diameter, 75mm in length). Bilateral BL35 will be inserted to a depth of 50 to 60mm with a slightly superolateral direction using needles (0.30mm in diameter, 75mm in length). BL23 and SP6 will be inserted vertically to a depth of 25 to 30mm using needles (0.30mm in diameter, 40mm in length). Manipulation of the needles by lifting and thrusting combined with twirling and rotating evenly will be performed until deqi occurs, defined as a sensation of soreness, numbness, heaviness, and ache. Manipulations will be applied every 10minutes and each session will last for 30minutes.

Intervention Type: OTHER

Sham acupuncture

Bilateral sham BL 23, BL 33, BL 35 (15mmto BL23, BL33, and BL35) and SP6 (10mmto SP6) will be inserted by needles (0.20mm in diameter, 25mm in length) to a depth of 2 to 3mm without manipulation.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• meet the diagnostic criteria according to the NIH CP/CPPS consensus: discomfort or pain in the pelvic region for at least 3 months in the previous 6 months
• 18-50 years
• NIH-CPSI total score ≥15

Exclusion Criteria

• Urologic disease
• Residual urine volume ≥100 milliliter (mL)
• Qmax ≤15mL/s
• Use 5-alpha reductase inhibitor, alpha-blockers, antibiotics or any other prostatitis-specific medication during previous 1 month
• Diseases that influence urologic symptoms are multiple sclerosis, multiple system atrophy, stroke, Alzheimer disease, Parkinson's disease, spinal cord injury, cauda equina injury, and sexually transmitted disease
• Any acute disease or severe disease requiring treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Zhou Jing

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, China

Site Status: RECRUITING

Hengyang Hospital Affiliated to Hunan University of Chinese Medicine

Hengyang, Hunan, China

Site Status: RECRUITING

Yantai Hospital of Traditional Chinese Medicine

Yantai, Shandong, China

Site Status: RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jing Zhou, Master

Role: CONTACT

zjinbj@sina.com

86-010-15650729586

Facility Contacts

Wei Zhang

Role: primary

Zenghui Yue

Role: primary

Zhiwei Zang

Role: primary

Ning Li

Role: primary

Other Identifiers

2018-098-KY

Identifier Type: -

Identifier Source: org_study_id