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Trial record 18 of 21 for:    Recruiting, Not yet recruiting, Available Studies | "Sterilization, Reproductive"

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

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ClinicalTrials.gov Identifier: NCT03641807
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Zhou Jing, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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 co-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 10 minutes 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 1-3 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.


Condition or disease Intervention/treatment Phase
Chronic Prostatitis Chronic Pelvic Pain Syndrome Other: Acupuncture Other: Sham acupuncture Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Comparison of Three Different Modes of Assessment on Acupuncture Effect on Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome: a Study Protocol for a Randomized Controlled Trial
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 6, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acupuncture Other: Acupuncture
Bilateral Shenshu (BL23), Zhongliao (BL33), Huiyang (BL35) and Sanyinjiao (SP6) will be inserted by disposable acupuncture needles (sizes 0.30 × 75 and 0.30 × 40 mm). After routine sterilization with patients in a prone position, bilateral Zhongliao (BL33) will be inserted to a depth of 50-60 mm with a 30°to 45°angle in an inferomedial direction by using needles (0.30 mm in diameter, 75 mm in length). Bilateral Huiyang (BL35) will be inserted to a depth of 50-60 mm with a slightly superolateral direction by using needles (0.30 mm in diameter, 75 mm in length). Bilateral Shenshu (BL23) and Sanyinjiao (SP6) will be inserted vertically to a depth of 25-30 mm by using needles (0.30 mm in diameter, 40 mm in length). Manipulation of lifting and thrusting combined with twirling and rotating evenly until "deqi". Manipulations will be applied every 10 minutes and each session will last for 30 minutes. Participants will be treated for 4 weeks, 3 sessions a week with a total of 12 sessions.

Sham Comparator: Sham acupuncture Other: Sham acupuncture
Bilateral sham BL 23, BL 33, BL 35 (15 mm to BL23, BL33 and BL35) and SP6 (10 mm to SP6) will be inserted by needles (0.20 mm in diameter, 25 mm in length) to a depth of 2-3mm without manipulation. Participants will be treated for 4 weeks, 3 sessions a week with a total of 12 sessions.




Primary Outcome Measures :
  1. The change from baseline of total score of National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) after 4-week treatment [ Time Frame: week 4 ]
    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).


Secondary Outcome Measures :
  1. Mode 1 (filling the scale at the hospital within 10 minutes after the last session of 4-week acupuncture treatment being in the company of outcome assessors) of assessment for change from baseline of NIH-CPSI [ Time Frame: week 4 ]
    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).

  2. Mode 2 (filling the scale at the same day which is the same as Mode 1 but not at hospital) of assessment for change from baseline of NIH-CPSI [ Time Frame: week 4 ]
    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).

  3. Mode 3 (filling the scale at the hospital 1 to 3 days after the last acupuncture session) of assessment for change from baseline of NIH-CPSI [ Time Frame: week 4 ]
    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).

  4. The change from baseline of subscales scores of NIH-CPSI [ Time Frame: week 4 ]
    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).

  5. The change from baseline of International Prostate Symptom Score (IPSS) [ Time Frame: week 4 ]
    International Prostate Symptom Score (IPSS) (Hong Kong Chinese version 2) is a valid, reliable and sensitive measure to assess Chinese males with 7 questions concerning urinary symptoms and 1 question concerning quality of life [34]. Total score of IPSS ranges from 0-35 (asymptomatic to very symptomatic). Symptoms evaluated by IPSS are categorized as mild (0-7), moderate (8-19) and severe (20-35).

  6. The proportions of participants in each response category of the Global Response Assessment (GRA) [ Time Frame: week 4 ]
    Global Response Assessment (GRA) which is composed of 7 response categories: markedly worsened, moderately worsened, slightly worsened, no change, slightly improved, moderately improved, and markedly improved.


Other Outcome Measures:
  1. Expectancy of acupuncture [ Time Frame: Baseline ]
    Participants need to answer two questions: "In general, do you believe acupuncture is effective for treating the illness?" and "Do you think acupuncture will be helpful to improve your CP/CPPS symptoms?" Participants will choose "Unclear", "Yes" or "No" as the answer.

  2. Blinding assessment [ Time Frame: week 4 ]
    Participants will be asked to reply to the question ("Do you think you have received traditional acupuncture in the past weeks?") after treatment (sessions 11 or 12) within 5 minutes. The participants will be able to choose one of the following options as the answer: "Unclear", "Yes" or "No".

  3. Incidence of adverse events (AEs) related with acupuncture [ Time Frame: week 1 to week 4 ]
    AEs related to acupuncture include severe pain (assessed by VAS, 7 points at least), broken needle, fainting, local hematoma, localized infection and post-acupuncture discomfortable symptoms such as nausea, vomiting, palpitation, dizziness, headache, anorexia and insomnia, etc. during treatment period.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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:

  • have urologic disease (eg, bladder outlet obstruction, overactive bladder, neuropathic bladder, interstitial cystitis, cystitis glandularis, bladder cancer, acute prostatitis or bacterial prostatitis, benign prostatic hyperplasia, prostate cancer, symptomatic urinary tract infection, and organic diseases of urinary system)
  • 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
  • have diseases that influence urologic symptoms (eg, multiple sclerosis, multiple system atrophy, stroke, alzheimer's disease, Parkinson's disease, spinal cord injury, cauda equina injury, sexually transmitted disease)
  • have any acute disease or severe disease requiring treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03641807


Contacts
Contact: Jing Zhou, Master 86-010-15650729586 zjinbj@sina.com

Locations
China, Hunan
The First Hospital of Hunan University of Chinese Medicine Recruiting
Changsha, Hunan, China
Contact: Wei Zhang         
Hengyang Hospital Affiliated to Hunan University of Chinese Medicine Recruiting
Hengyang, Hunan, China
Contact: Zenghui Yue         
China, Shandong
Yantai Hospital of Traditional Chinese Medicine Recruiting
Yantai, Shandong, China
Contact: Zhiwei Zang         
China, Sichuan
West China Hospital of Sichuan University Recruiting
Chengdu, Sichuan, China
Contact: Ning Li         
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Responsible Party: Zhou Jing, Principal Investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03641807     History of Changes
Other Study ID Numbers: 2018-098-KY
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Somatoform Disorders
Pelvic Pain
Prostatitis
Chronic Disease
Disease
Pathologic Processes
Mental Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Disease Attributes