An interventional study of Acupuncture and Sham acupuncture in Chronic Prostatitis With Chronic Pelvic Pain Syndrome, sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences. Completed at 1 site in China. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-08-09.
Sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Not applicable, Interventional, and Treatment
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) refers to the presence of bothersome pelvic pain symptoms without an identifiable cause. Common symptoms of CP/CPPS include discomfort in the perineum, suprapubic region, and lower urinary tract symptoms. It affects men of all ages without apparent racial predisposition, among which, 36-50 years old are the most commonly influenced. Yet, few effective therapies are available for treating CP/CPPS.
Acupuncture may be an effective treatment option for CP/CPPS. However, effects of acupuncture on CP/CPPS remain uncertain because of the small sample sizes or other methodological limitations.
The objective of this multi-centre, randomized, sham acupuncture-controlled trial is to assess the effectiveness of acupuncture for relieving symptoms of CP/CPPS. The results will provide a robust conclusion with a high level of evidence.
88 studies on the registry are indexed under Prostatitis; 11 are open to participants now.
This study's enrollment of 440 is above the median of 60 across 73 interventional studies indexed under Prostatitis.
Browse Prostatitis studies →Guang'anmen Hospital of China Academy of Chinese Medical Sciences is the lead sponsor of 137 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The participants in the acupuncture group will receive treatment that consists of 20 acupuncture sessions over an 8-week (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks) period after baseline, each for 30 minutes. Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used. Sanyinjiao (SP6), Zhongliao (BL33), Shenshu (BL23), and Huiyang (BL35), were selected as acupoints protocol. SP6 is on the tibial aspect of the leg, posterior to the medial border of the tibia, 3 cun superior to the prominence of the medial malleolus; BL32 is in the sacral region, in the second posterior sacral foramen; BL33 is in the third posterior sacral foramen; BL35 is in the buttock region, 0.5 cun lateral to the extremity of the coccyx.
Device: Acupuncture
The participants in the sham acupuncture group will receive shallow needling at bilateral sham BL23, BL33, BL35 and SP6. The protocol includes the same duration and frequency of sessions as for the acupuncture treatment, but the treatment was delivered superficially at non-acupuncture points 10-15 mm to the lateral of corresponding acupuncture and not above a meridian line (15mm to BL23, BL33 and BL35; 10mm to SP6). The Hwato brand disposable acupuncture needles (size 0.30 × 25mm) will be inserted with a depth of 2-3 mm without any manipulation.
Device: Sham acupuncture
For acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used. Bilateral SP6, BL33, BL23, and BL35, were selected as acupoints protocol. Acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks).
For sham acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 25mm) will be used to insert vertically about 2-3 mm without manipulation into non-acupoints bilateral sham SP6, sham BL33, sham BL23, and sham BL35, which were located at different physical locations than SP6, BL23, BL 33, and BL35. Sham acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks).
Proportion of Responders at the End of 8-week
The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI).
Time frame: week 8
Proportion of Responders at the End of 32-week
The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the NIH-CPSI.
Time frame: week 32
Proportion of Responders at Other Time Points
The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the NIH-CPSI.
Time frame: weeks 1-7; week 20
the Change From Baseline in NIH-CPSI Total Score
The National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) is a universally accepted, reliable and valid instrument recommended for clinical evaluation and research of CP/CPPS by consensus guidelines. It measures the domains of pain (score range, 0-21), urinary function (0-10) and quality of life impact (0-12) in CP/CPPS, with a total score ranging from 0 to 43 and higher scores indicating worse conditions.
Time frame: weeks 1-8; week 20; week 32
the Change From Baseline in NIH-CPSI Subscales
The NIH-CPSI is a universally accepted, reliable and valid instrument recommended for clinical evaluation and research of CP/CPPS by consensus guidelines. It measures the domains of pain, urinary function and quality of life impact in CP/CPPS. The score range of pain subscale is 0-21, with higher scores indicating worse conditions. The score range of urinary function subscale is 0-10, with higher scores indicating worse conditions. The score range of quality-of-life subscale is 0-12, with higher scores indicating worse quality of life.
Time frame: weeks 1-8; week 20; week 32
the Change From Baseline in the International Prostate Symptom Score (IPSS)
IPSS is a valid, reliable and sensitive measure for patients with lower urinary tract symptoms; it is widely used in clinical practice and research to determine the severity of lower urinary tract symptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency, weak urine stream, straining and nocturia. Each of the questions is rated from 0 (not at all) to 5 (almost always). IPSS score ranges from 0 to 35, with higher score indicating more severe urinary symptoms.
Time frame: week 4; week 8; week 20; week 32
the Change From Baseline in the Hospital Anxiety and Depression Scale (HADS)
HADS is made up of 7 items for the assessment of depression and anxiety; the completion of this scale usually requires 2-5 minutes. HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
Time frame: week 8; week 20; week 32
the Change From Baseline in the International Index of Erectile Function 5 (IIEF-5)
The IIEF-5 is a psychometrically valid and reliable instrument with high sensitivity and specificity for detecting treatment effects in patients with erection dysfunction of a broad spectrum of aetiology. Chinese version IIEF-5 score ranges from 0 to 25, with lower scores indicating greater severity of dysfunction and minimal clinical important difference over 5.
Time frame: week 8; week 20; week 32
the Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire
The EQ-5D-5L is a well-established and suitable for evaluation of quality of life in participants with CP/CPPS. EQ-5D-5L overall index ranges from -0.39 to 1.00, with higher overall index indicating better generic health-status.
Time frame: week 8; week 20; week 32
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
GRA consists of 7 response categories: markedly worsened, moderately worsened, slightly worsened, no change, slightly improved, moderately improved, and markedly improved.
Time frame: week 4; week 8; week 20; week 32
the Change for Peak and Average Urinary Flow Rate From Baseline
Time frame: weeks 8 and 32
Expectation Assessment
Expectation assessment will be assessed at baseline, which includes 2 brief questions to investigate whether patients are confident that acupuncture treatment will help their CP/CPPS: "In general, is acupuncture effective for controlling the illness?", "Do you think acupuncture will helpful to improve your CP/CPPS symptoms?" For each question, participants could choose "Yes", "No" or "unclear" as the answer.
Time frame: baseline
| Milestone | Acupuncture | Sham Acupuncture |
|---|---|---|
| Started | 220 | 220 |
| Completed | 206 | 208 |
| Not completed | 14 | 12 |
| Withdrew: Lost to follow-up | 4 | 3 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Withdrew: Decline to participate | 5 | 4 |
| Withdrew: Without reason | 4 | 5 |
The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI).
| percentage of participants | Acupuncture | Sham Acupuncture |
|---|---|---|
| Proportion of Responders at the End of 8-week | 60.6 | 36.8 |
The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the NIH-CPSI.
| percentage of participants | Acupuncture | Sham Acupuncture |
|---|---|---|
| Proportion of Responders at the End of 32-week | 61.5 | 38.3 |
The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the NIH-CPSI.
| percentage of participants | Acupuncture | Sham Acupuncture |
|---|---|---|
| Week 1 | 9.1 | 8.3 |
| Week 2 | 15.2 | 13.9 |
| Week 3 | 27.2 | 19.8 |
| Week 4 | 39.5 | 26.4 |
| Week 5 | 42.6 | 24.1 |
| Week 6 | 53.0 | 33.3 |
| Week 7 | 61.0 | 35.3 |
| Week 20 | 64.1 | 34.8 |
The National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) is a universally accepted, reliable and valid instrument recommended for clinical evaluation and research of CP/CPPS by consensus guidelines. It measures the domains of pain (score range, 0-21), urinary function (0-10) and quality of life impact (0-12) in CP/CPPS, with a total score ranging from 0 to 43 and higher scores indicating worse conditions.
| score on a scale | Acupuncture | Sham Acupuncture |
|---|---|---|
| Week 1 | -1.9 (-2.4 to -1.5) | -1.3 (-1.8 to -0.9) |
| Week 2 | -2.9 (-3.4 to -2.4) | -2.4 (-2.9 to -1.9) |
| Week 3 | -3.9 (-4.4 to -3.4) | -3.0 (-3.5 to -2.5) |
| Week 4 | -4.8 (-5.4 to -4.3) | -3.7 (-4.2 to -3.1) |
| Week 5 | -5.2 (-5.8 to -4.6) | -3.7 (-4.3 to -3.2) |
| Week 6 | -5.9 (-6.5 to -5.3) | -4.0 (-4.6 to -3.5) |
| Week 7 | -6.7 (-7.3 to -6.1) | -4.6 (-5.2 to -4.0) |
| Week 8 | -7.4 (-8.0 to -6.8) | -4.9 (-5.5 to -4.3) |
| Week 20 | -7.2 (-8.0 to -6.6) | -4.5 (-5.2 to -3.9) |
| Week 32 | -7.4 (-8.1 to -6.7) | -4.9 (-5.5 to -4.2) |
The NIH-CPSI is a universally accepted, reliable and valid instrument recommended for clinical evaluation and research of CP/CPPS by consensus guidelines. It measures the domains of pain, urinary function and quality of life impact in CP/CPPS. The score range of pain subscale is 0-21, with higher scores indicating worse conditions. The score range of urinary function subscale is 0-10, with higher scores indicating worse conditions. The score range of quality-of-life subscale is 0-12, with higher scores indicating worse quality of life.
| score on a scale | Acupuncture | Sham Acupuncture |
|---|---|---|
| Change in NIH-CPSI pain subscale at week 1 | -0.6 (-0.9 to -0.4) | -0.5 (-0.7 to -0.2) |
| Change in NIH-CPSI pain subscale at week 2 | -0.8 (-1.1 to -0.6) | -0.8 (-1.0 to -0.5) |
| Change in NIH-CPSI pain subscale at week 3 | -1.1 (-1.4 to -0.9) | -0.8 (-1.1 to -0.6) |
| Change in NIH-CPSI pain subscale at week 4 | -1.6 (-1.8 to -1.3) | -1.1 (-1.3 to -0.9) |
| Change in NIH-CPSI pain subscale at week 5 | -1.5 (-1.7 to -1.2) | -1.1 (-1.3 to -0.9) |
| Change in NIH-CPSI pain subscale at week 6 | -1.8 (-2.0 to -1.5) | -1.1 (-1.4 to -0.9) |
| Change in NIH-CPSI pain subscale at week 7 | -2.0 (-2.3 to -1.8) | -1.3 (-1.5 to -1.1) |
| Change in NIH-CPSI pain subscale at week 8 | -2.1 (-2.4 to -1.9) | -1.3 (-1.5 to -1.1) |
| Change in NIH-CPSI pain subscale at week 20 | -2.0 (-2.3 to -1.8) | -1.0 (-1.2 to -0.7) |
| Change in NIH-CPSI pain subscale at week 32 | -2.0 (-2.3 to -1.8) | -1.3 (-1.5 to -1.0) |
| Change in NIH-CPSI urinary subscale at week 1 | -0.5 (-0.7 to -0.3) | -0.4 (-0.6 to -0.2) |
| Change in NIH-CPSI urinary subscale at week 2 | -0.8 (-1.0 to -0.6) | -0.6 (-0.8 to -0.4) |
| Change in NIH-CPSI urinary subscale at week 3 | -1.0 (-1.3 to -0.8) | -0.9 (-1.1 to -0.7) |
| Change in NIH-CPSI urinary subscale at week 4 | -1.3 (-1.6 to -1.1) | -1.0 (-1.2 to -0.8) |
| Change in NIH-CPSI urinary subscale at week 5 | -1.6 (-1.8 to -1.3) | -1.1 (-1.3 to -0.9) |
| Change in NIH-CPSI urinary subscale at week 6 | -1.7 (-1.9 to -1.5) | -1.2 (-1.4 to -0.9) |
| Change in NIH-CPSI urinary subscale at week 7 | -1.9 (-2.2 to -1.7) | -1.3 (-1.6 to -1.1) |
| Change in NIH-CPSI urinary subscale at week 8 | -2.1 (-2.4 to -1.9) | -1.4 (-1.6 to -1.2) |
| Change in NIH-CPSI urinary subscale at week 20 | -2.1 (-2.3 to -1.8) | -1.5 (-1.7 to -1.2) |
| Change in NIH-CPSI urinary subscale at week 32 | -2.1 (-2.4 to -1.9) | -1.5 (-1.8 to -1.2) |
| Change in NIH-CPSI quality of life subscale at week 1 | -0.8 (-0.9 to -0.6) | -0.5 (-0.7 to -0.3) |
| Change in NIH-CPSI quality of life subscale at week 2 | -1.2 (-1.4 to -1.0) | -0.9 (-1.2 to -0.7) |
| Change in NIH-CPSI quality of life subscale at week 3 | -1.7 (-1.9 to -1.5) | -1.2 (-1.4 to -1.0) |
| Change in NIH-CPSI quality of life subscale at week 4 | -1.9 (-2.2 to -1.7) | -1.5 (-1.8 to -1.3) |
| Change in NIH-CPSI quality of life subscale at week 5 | -2.2 (-2.4 to -1.9) | -1.5 (-1.8 to -1.3) |
| Change in NIH-CPSI quality of life subscale at week 6 | -2.4 (-2.7 to -2.2) | -1.7 (-2.0 to -1.5) |
| Change in NIH-CPSI quality of life subscale at week 7 | -2.8 (-3.0 to -2.5) | -1.9 (-2.2 to -1.7) |
| Change in NIH-CPSI quality of life subscale at week 8 | -3.1 (-3.4 to -2.8) | -2.2 (-2.4 to -1.9) |
| Change in NIH-CPSI quality of life subscale at week 20 | -3.2 (-3.5 to -2.8) | -2.0 (-2.4 to -1.7) |
| Change in NIH-CPSI quality of life subscale at week 32 | -3.1 (-3.5 to -2.8) | -2.1 (-2.4 to -1.8) |
IPSS is a valid, reliable and sensitive measure for patients with lower urinary tract symptoms; it is widely used in clinical practice and research to determine the severity of lower urinary tract symptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency, weak urine stream, straining and nocturia. Each of the questions is rated from 0 (not at all) to 5 (almost always). IPSS score ranges from 0 to 35, with higher score indicating more severe urinary symptoms.
| score on a scale | Acupuncture | Sham Acupuncture |
|---|---|---|
| Week 4 | -2.7 (-3.2 to -2.3) | -1.7 (-2.1 to -1.2) |
| Week 8 | -4.4 (-4.9 to -3.9) | -2.7 (-3.2 to -2.2) |
| Week 20 | -4.7 (-5.3 to -4.2) | -3.0 (-3.6 to -2.4) |
| Week 32 | -4.7 (-5.4 to -4.1) | -3.1 (-3.8 to -2.5) |
HADS is made up of 7 items for the assessment of depression and anxiety; the completion of this scale usually requires 2-5 minutes. HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
| score on a scale | Acupuncture | Sham Acupuncture |
|---|---|---|
| Week 8 | -1.9 (-2.5 to -1.4) | -0.8 (-1.3 to -0.3) |
| Week 20 | -2.4 (-3.0 to -1.8) | -0.6 (-1.3 to 0.0) |
| Week 32 | -2.8 (-3.5 to -2.2) | -0.5 (-1.2 to 0.1) |
The IIEF-5 is a psychometrically valid and reliable instrument with high sensitivity and specificity for detecting treatment effects in patients with erection dysfunction of a broad spectrum of aetiology. Chinese version IIEF-5 score ranges from 0 to 25, with lower scores indicating greater severity of dysfunction and minimal clinical important difference over 5.
| score on a scale | Acupuncture | Sham Acupuncture |
|---|---|---|
| Week 8 | 0.8 (0.2 to 1.3) | 0.3 (-0.3 to 0.8) |
| Week 20 | 0.7 (0.2 to 1.3) | 0.2 (-0.3 to 0.7) |
| Week 32 | 1.0 (0.4 to 1.6) | 0.4 (-0.1 to 1.0) |
The EQ-5D-5L is a well-established and suitable for evaluation of quality of life in participants with CP/CPPS. EQ-5D-5L overall index ranges from -0.39 to 1.00, with higher overall index indicating better generic health-status.
| units on a scale | Acupuncture | Sham Acupuncture |
|---|---|---|
| Week 8 | 0.06 (0.05 to 0.07) | 0.03 (0.02 to 0.04) |
| Week 20 | 0.06 (0.05 to 0.07) | 0.03 (0.02 to 0.04) |
| Week 32 | 0.06 (0.05 to 0.08) | 0.03 (0.02 to 0.04) |
GRA consists of 7 response categories: markedly worsened, moderately worsened, slightly worsened, no change, slightly improved, moderately improved, and markedly improved.
| percentage of participants | Acupuncture | Sham Acupuncture |
|---|---|---|
| Week 4 : Markedly improved | 15.9 | 7.5 |
| Week 4 : Moderately improved | 24.0 | 14.6 |
| Week 4 : Slightly improved | 46.6 | 50.7 |
| Week 4 : No change | 13.0 | 25.4 |
| Week 4 : Slightly worsened | 0.5 | 1.9 |
| Week 4 : Moderately worsened | 0 | 0 |
| Week 4 : Markedly worsened | 0 | 0 |
| Week 8 : Markedly improved | 30.6 | 8.7 |
| Week 8 : Moderately improved | 36.4 | 27.9 |
| Week 8 : Slightly improved | 27.2 | 40.9 |
| Week 8 : No change | 5.3 | 19.2 |
| Week 8 : Slightly worsened | 0.5 | 3.4 |
| Week 8 : Moderately worsened | 0 | 0 |
| Week 8 : Markedly worsened | 0 | 0 |
| Week 20 : Markedly improved | 24.3 | 6.7 |
| Week 20 : Moderately improved | 24.3 | 17.8 |
| Week 20 : Slightly improved | 27.7 | 31.7 |
| Week 20 : No change | 19.4 | 30.3 |
| Week 20 : Slightly worsened | 4.4 | 12.0 |
| Week 20 : Moderately worsened | 0 | 1.4 |
| Week 20 : Markedly worsened | 0 | 0 |
| Week 32 : Markedly improved | 22.3 | 8.2 |
| Week 32 : Moderately improved | 24.8 | 16.8 |
| Week 32 : Slightly improved | 27.2 | 29.3 |
| Week 32 : No change | 20.9 | 32.7 |
| Week 32 : Slightly worsened | 4.4 | 8.7 |
| Week 32 : Moderately worsened | 0.5 | 3.9 |
| Week 32 : Markedly worsened | 0 | 0.5 |
| ml/s | Acupuncture | Sham Acupuncture |
|---|---|---|
| Changes in peak urinary flow rate at week 8 | 0.6 (-0.3 to 1.6) | 0.7 (-0.2 to 1.6) |
| Changes in peak urinary flow rate at week 32 | 0.5 (-0.4 to 1.3) | -0.6 (-1.4 to 0.2) |
| Changes in average urinary flow rate at week 8 | 0.6 (0.1 to 1.1) | 0.4 (-0.1 to 0.9) |
| Changes in average urinary flow rate at week 32 | 0.5 (0.1 to 1.0) | -0.2 (-0.6 to 0.3) |
Expectation assessment will be assessed at baseline, which includes 2 brief questions to investigate whether patients are confident that acupuncture treatment will help their CP/CPPS: "In general, is acupuncture effective for controlling the illness?", "Do you think acupuncture will helpful to improve your CP/CPPS symptoms?" For each question, participants could choose "Yes", "No" or "unclear" as the answer.
| Participants | Acupuncture | Sham Acupuncture |
|---|---|---|
| Do you believe acupuncture is effective for treating diseases in general? — Yes | 167 | 165 |
| Do you believe acupuncture is effective for treating diseases in general? — No | 0 | 1 |
| Do you believe acupuncture is effective for treating diseases in general? — Unclear | 46 | 49 |
| Do you think acupuncture will be helpful to improve your CP/CPPS symptoms? — Yes | 156 | 150 |
| Do you think acupuncture will be helpful to improve your CP/CPPS symptoms? — No | 0 | 1 |
| Do you think acupuncture will be helpful to improve your CP/CPPS symptoms? — Unclear | 57 | 64 |
Collected over 34 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acupuncture | 0/220 (0%) | 0/220 (0%) | 20/220 (9.1%) |
| Sham Acupuncture | 0/220 (0%) | 0/220 (0%) | 14/220 (6.4%) |
| Event | Acupuncture | Sham Acupuncture |
|---|---|---|
| Subcutaneous hematomaSkin and subcutaneous tissue disorders | 9/220 | 5/220 |
| ColdGeneral disorders | 7/220 | 6/220 |
| Localized infectionInfections and infestations | 1/220 | 0/220 |
| NauseaGastrointestinal disorders | 1/220 | 0/220 |
| FeverGeneral disorders | 1/220 | 1/220 |
| TonsillitisRespiratory, thoracic and mediastinal disorders | 0/220 | 1/220 |
| FallInjury, poisoning and procedural complications | 0/220 | 1/220 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 1/220 | 0/220 |
| Acute gastritisGastrointestinal disorders | 0/220 | 1/220 |
| Age, Continuous(years) | Acupuncture | Sham Acupuncture | Total |
|---|---|---|---|
| Mean | 35.5 ± 8.0 | 36.1 ± 7.9 | 35.8 ± 8.0 |
| Sex: Female, Male(Participants) | Acupuncture | Sham Acupuncture | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 220 | 220 | 440 |
| Race/Ethnicity, Customized(Participants) | Acupuncture | Sham Acupuncture | Total |
|---|---|---|---|
| Han | 213 | 214 | 427 |
| Others | 2 | 2 | 4 |
| Region of Enrollment(participants) | Acupuncture | Sham Acupuncture | Total |
|---|---|---|---|
| China | 220 | 220 | 440 |
| National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score(units on a scale) | Acupuncture | Sham Acupuncture | Total |
|---|---|---|---|
| Mean | 31.0 ± 4.8 | 31.4 ± 5.2 | 31.2 ± 5.0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Deidentified participant data and data dictionary will be available with publication until six months after publication. Formal request should be sent to the corresponding author (zhishunjournal@163.com) with a methodologically sound proposal. Researchers whose proposal has been approved will sign a data access agreement
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: The data will be available with publication until until six months after publication.
Access criteria: Formal request should be sent to the corresponding author (zhishunjournal@163.com) with a methodologically sound proposal. Researchers whose proposal has been approved. Researchers whose proposal has been approved will sign a data access agreement
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