Have you or your loved ones been diagnosed with chronic pelvic pain syndrome?

You may be eligible to participate in a chronic pelvic pain syndrome clinical trial.

Have you or your loved ones been diagnosed with chronic pelvic pain syndrome? You may be eligible to participate in a chronic pelvic pain syndrome clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Chronic Pelvic Pain Syndrome Clinical Trial in Hengyang Hunan

NCT03641807 | Interventional

Have you or your loved ones been diagnosed with chronic pelvic pain syndrome?

You may be eligible to participate in a chronic pelvic pain syndrome clinical trial.

Have you or your loved ones been diagnosed with chronic pelvic pain syndrome? You may be eligible to participate in a chronic pelvic pain syndrome clinical trial.

Recruiting

Male

18 - 50

Years old

This study is looking to recruit 60 Participants

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.

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Details for the study

Brief Title

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

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

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.

Treatments and/or Procedures

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.

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

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

Primary

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

Primary

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

The change from baseline of subscales scores of NIH-CPSI

week 4

Secondary

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

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

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

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).

week 4

Secondary

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

week 4

Secondary

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

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

Secondary

The proportions of participants in each response category of the Global Response Assessment (GRA)

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.

week 4

Other

Incidence of adverse events (AEs) related with acupuncture

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.

week 1 to week 4

Other

Blinding assessment

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".

week 4

Other

Expectancy of acupuncture

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.

Baseline

Study 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