An interventional study of Acupuncture and Sham acupuncture in Chronic Prostatitis and Chronic Pelvic Pain Syndrome, sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences. Status unknown at 4 sites in China. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-09-09.
Sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Other: Acupuncture
Other: Sham 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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 1 to 3 days after the last acupuncture session
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.
Time frame: week 4
Mode 2 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 2, the scale is recorded the same day, but not at the hospital.
Time frame: week 4
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.
Time frame: 1 to 3 days after the last acupuncture session
The change from baseline of subscales scores of NIH-CPSI
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).
Time frame: week 4
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).
Time frame: week 4
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.
Time frame: week 4
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.
Time frame: Baseline
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".
Time frame: week 4
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.
Time frame: week 1 to week 4
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences