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

NCT03641807 | Unknown

• 1 other identifier: 2018-098-KY
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (3)

• The change from baseline in total score of National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) measured by the assessment of mode 1

  The National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) has a total score range from 0 to 43 and higher scores indicate more severe symptoms. The 9 items of this scale are stratified into 3 domains which are pain/discomfort (location/type, frequency and severity, 0-21 points), urinary symptoms (10 points) and quality of life (0-12 points). Mode 1, the scale is recorded at the hospital within 10minutes after the twelfth (last) treatment of the 4-week treatment period, in the company of the outcome assessors.

  week 4

• The change from baseline in total score of National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) measured by the assessment of mode 2

  The National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) has a total score range from 0 to 43 and higher scores indicate more severe symptoms. The 9 items of this scale are stratified into 3 domains which are pain/discomfort (location/type, frequency and severity, 0-21 points), urinary symptoms (10 points) and quality of life (0-12 points). Mode 2, the scale is recorded the same day, but not at the hospital.

  week 4

• The change from baseline in total score of National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) measured by the assessment of mode 3

  The National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) has a total score range from 0 to 43 and higher scores indicate more severe symptoms. The 9 items of this scale are stratified into 3 domains which are pain/discomfort (location/type, frequency and severity, 0-21 points), urinary symptoms (10 points) and quality of life (0-12 points). Mode 3, the scale is recorded at the hospital 1 to 3 days after the last acupuncture session.

  1 to 3 days after the last acupuncture session

Secondary Outcomes (6)

• Mode 1 of assessment of the changes from baseline of NIH-CPSI total score in the acupuncture group

  week 4

• Mode 2 of assessment of the changes from baseline of NIH-CPSI total score in the acupuncture group

  week 4

• Mode 3 of assessment of the changes from baseline of NIH-CPSI total score in the acupuncture group

  1 to 3 days after the last acupuncture session

• The change from baseline of subscales scores of NIH-CPSI

  week 4

• The change from baseline of International Prostate Symptom Score (IPSS)

  week 4

Other Outcomes (3)

• Expectancy of acupuncture

  Baseline

• Blinding assessment

  week 4

• Incidence of adverse events (AEs) related with acupuncture

  week 1 to week 4

Study Arms (2)

Acupuncture

EXPERIMENTAL

Other: Acupuncture

Sham acupuncture

SHAM COMPARATOR

Other: Sham acupuncture

Interventions

Acupuncture 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.

Acupuncture

Sham acupuncture 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.

Sham acupuncture

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• years
• NIH-CPSI total score ≥15

You may not qualify if:

• 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

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (4)

The First Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, China

RECRUITING

Hengyang Hospital Affiliated to Hunan University of Chinese Medicine

Hengyang, Hunan, China

RECRUITING

Yantai Hospital of Traditional Chinese Medicine

Yantai, Shandong, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Jing Zhou, Master

CONTACT

86-010-15650729586; zjinbj@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 22, 2018
• Study Start: November 1, 2018
• Primary Completion: June 30, 2021
• Study Completion: October 30, 2021
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

CN (4)