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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | 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. |
|
| Sham acupuncture | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | weeks 1-7; week 20 |
| the Change From Baseline in NIH-CPSI Total Score |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhishun Liu | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'anmen Hospital, China Academy of Chinese Medical Science | Beijing | Beijing Municipality | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29273095 | Background | Qin Z, Liu Y, Zhou K, Wu J, Pang R, Li N, Xu C, Kwong JSW, Liu Z. Acupuncture for chronic prostatitis/chronic pelvic pain syndrome: study protocol for a randomized controlled trial. Trials. 2017 Dec 22;18(1):616. doi: 10.1186/s13063-017-2383-8. | |
| 34399062 | Result | Sun Y, Liu Y, Liu B, Zhou K, Yue Z, Zhang W, Fu W, Yang J, Li N, He L, Zang Z, Su T, Fang J, Ding Y, Qin Z, Song H, Hu H, Zhao H, Mo Q, Zhou J, Wu J, Liu X, Wang W, Pang R, Chen H, Wang X, Liu Z. Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome : A Randomized Trial. Ann Intern Med. 2021 Oct;174(10):1357-1366. doi: 10.7326/M21-1814. Epub 2021 Aug 17. |
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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
The data will be available with publication until 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.
Researchers whose proposal has been approved will sign a data access agreement
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| ID | Title | Description |
|---|---|---|
| FG000 | Acupuncture | 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. 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). |
| FG001 | Sham 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. Sham acupuncture: 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acupuncture | 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. 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Number | percentage of participants | week 8 |
|
34 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acupuncture | 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. 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subcutaneous hematoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zhishun Liu | Guang'anmen Hospital, China Academy Chinese Medical Sciences | +86 010 88002331 | liuzhishun@aliyun.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 4, 2017 | Aug 27, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D011472 | Prostatitis |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
| Sham acupuncture | Device | 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). |
|
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.
| 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. | 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. | 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. | 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. | 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. | 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. | week 4; week 8; week 20; week 32 |
| the Change for Peak and Average Urinary Flow Rate From Baseline | weeks 8 and 32 |
| baseline |
| 39219163 | Derived | Zhu L, Sun Y, Yan S, Liu X, Wang X, Liu Z. Efficacy of acupuncture on drinkers with chronic prostatitis / chronic pelvic pain syndrome: secondary analysis of a randomized clinical trial. Acupunct Med. 2024 Oct;42(5):243-250. doi: 10.1177/09645284241274158. Epub 2024 Sep 1. |
| 37122487 | Derived | Zhu L, Fang J, Sun Y, Yang M, Yao H, Liu Z. Impact of ejaculation upon effect of acupuncture on chronic prostatitis/chronic pelvic pain syndrome: Secondary analysis of a randomized controlled trial. Integr Med Res. 2023 Jun;12(2):100943. doi: 10.1016/j.imr.2023.100943. Epub 2023 Apr 3. |
| Decline to participate |
|
| Without reason |
|
| BG001 | Sham 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. Sham acupuncture: 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | 5 participants in the acupuncture and 4 participants in the sham acupuncture group declined to participate the trial. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| National Institutes of Health Chronic Prostatitis Symptom Index (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 (score range, 0-10) and quality of life impact (score range, 0-12) in CP/CPPS, with a total score ranging from 0 to 43 (a combination of subscale scores) and higher scores indicating worse conditions. | 5 participants in the acupuncture group declined to participate the trial and did not receive treatment. 4 participants declined to participate the trial and 1 withdrew without reason in the sham acupuncture group. All those 5 participants did not receive treatment. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Sham 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. Sham acupuncture: 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). |
|
|
| Primary | 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. | Posted | Number | percentage of participants | week 32 |
|
|
|
| Secondary | 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. | Posted | Number | percentage of participants | weeks 1-7; week 20 |
|
|
|
| Secondary | 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. | Of the 220 participants randomly assigned to the acupuncture group, 206 completed 8-week treatment and 32-week follow-up: 5 declined to participate the trial, 4 lost to follow-up, 4 withdrew without reason and 1 withdrew because lack of perceived efficacy. Of the 220 participants randomly assigned to the sham acupuncture group, 208 completed 8-week treatment and 32-week follow-up: 4 declined to participate, 5 withdrew without reason and 3 lost to follow-up. | Posted | Mean | 95% Confidence Interval | score on a scale | weeks 1-8; week 20; week 32 |
|
|
|
| Secondary | 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. | Of the 220 participants randomly assigned to the acupuncture group, 206 completed 8-week treatment and 32-week follow-up: 5 declined to participate the trial, 4 lost to follow-up, 4 withdrew without reason and 1 withdrew because lack of perceived efficacy. Of the 220 participants randomly assigned to the sham acupuncture group, 208 completed 8-week treatment and 32-week follow-up: 4 declined to participate, 5 withdrew without reason and 3 lost to follow-up. | Posted | Mean | 95% Confidence Interval | score on a scale | weeks 1-8; week 20; week 32 |
|
|
|
| Secondary | 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. | Of the 220 participants randomly assigned to the acupuncture group, 206 completed 8-week treatment and 32-week follow-up. Additionally, the data of IPSS was not available for one participant at week 32 in the acupuncture group. Of the 220 participants randomly assigned to the sham acupuncture group, 208 completed 8-week treatment and 32-week follow-up. | Posted | Mean | 95% Confidence Interval | score on a scale | week 4; week 8; week 20; week 32 |
|
|
|
| Secondary | 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. | Of the 220 participants randomly assigned to the acupuncture group, 206 completed 8-week treatment and 32-week follow-up: 5 declined to participate the trial, 4 lost to follow-up, 4 withdrew without reason and 1 withdrew because lack of perceived efficacy. Of the 220 participants randomly assigned to the sham acupuncture group, 208 completed 8-week treatment and 32-week follow-up: 4 declined to participate, 5 withdrew without reason and 3 lost to follow-up. | Posted | Mean | 95% Confidence Interval | score on a scale | week 8; week 20; week 32 |
|
|
|
| Secondary | 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. | Of the 220 participants randomly assigned to the acupuncture group, 206 completed 8-week treatment and 32-week follow-up. Additionally, the data of IIEF-5 was not available for two participants at week 32. Of the 220 participants randomly assigned to the sham acupuncture group, 208 completed 8-week treatment and 32-week follow-up. Additionally, the data of IIEF-5 was not available for one participant at weeks 8, 20 and 32. | Posted | Mean | 95% Confidence Interval | score on a scale | week 8; week 20; week 32 |
|
|
|
| Secondary | 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. | Of the 220 participants randomly assigned to the acupuncture group, 206 completed 8-week treatment and 32-week follow-up: 5 declined to participate the trial, 4 lost to follow-up, 4 withdrew without reason and 1 withdrew because lack of perceived efficacy. Of the 220 participants randomly assigned to the sham acupuncture group, 208 completed 8-week treatment and 32-week follow-up: 4 declined to participate, 5 withdrew without reason and 3 lost to follow-up. | Posted | Mean | 95% Confidence Interval | units on a scale | week 8; week 20; week 32 |
|
|
|
| Secondary | 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. | Of the 220 participants randomly assigned to the acupuncture group, 206 completed 8-week treatment and 32-week follow-up: 5 declined to participate the trial, 4 lost to follow-up, 4 withdrew without reason and 1 withdrew because lack of perceived efficacy. Of the 220 participants randomly assigned to the sham acupuncture group, 208 completed 8-week treatment and 32-week follow-up: 4 declined to participate, 5 withdrew without reason and 3 lost to follow-up. | Posted | Number | percentage of participants | week 4; week 8; week 20; week 32 |
|
|
|
| Secondary | the Change for Peak and Average Urinary Flow Rate From Baseline | Of the 220 participants randomly assigned to the acupuncture group, 206 completed 8-week treatment and 32-week follow-up. Of the 220 participants randomly assigned to the sham acupuncture group, 208 completed 8-week treatment and 32-week follow-up. Additionally, the data of peak and average urinary flow rate was not available for several participants. | Posted | Mean | 95% Confidence Interval | ml/s | weeks 8 and 32 |
|
|
|
| Other Pre-specified | 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. | 5 participants in the acupuncture group declined to participate the trial and did not receive treatment. Additionally, the data of expectation assessment was not available for 2 participants in the acupuncture group. 4 participants declined to participate the trial and 1 withdrew without reason in the sham acupuncture group. All those 5 participants did not receive treatment. | Posted | Count of Participants | Participants | baseline |
|
|
|
| 0 |
| 220 |
| 0 |
| 220 |
| 20 |
| 220 |
| EG001 | Sham 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. Sham acupuncture: 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). | 0 | 220 | 0 | 220 | 14 | 220 |
| Localized infection | Infections and infestations | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cold | General disorders | Non-systematic Assessment |
|
| Fever | General disorders | Non-systematic Assessment |
|
| Tonsillitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Acute gastritis | Gastrointestinal disorders | Non-systematic Assessment |
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Not provided
Not provided
Not provided
| D052801 |
| Male Urogenital Diseases |
| Week 3 |
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| Week 4 |
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| Week 5 |
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| Week 6 |
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| Week 7 |
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| Week 20 |
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| Week 2 |
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| Week 3 |
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| Week 4 |
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| Week 5 |
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| Week 6 |
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| Week 7 |
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| Week 8 |
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| Week 20 |
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| Week 32 |
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| Change in NIH-CPSI pain subscale at week 2 |
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| Change in NIH-CPSI pain subscale at week 3 |
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| Change in NIH-CPSI pain subscale at week 4 |
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| Change in NIH-CPSI pain subscale at week 5 |
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| Change in NIH-CPSI pain subscale at week 6 |
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| Change in NIH-CPSI pain subscale at week 7 |
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| Change in NIH-CPSI pain subscale at week 8 |
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| Change in NIH-CPSI pain subscale at week 20 |
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| Change in NIH-CPSI pain subscale at week 32 |
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| Change in NIH-CPSI urinary subscale at week 1 |
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| Change in NIH-CPSI urinary subscale at week 2 |
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| Change in NIH-CPSI urinary subscale at week 3 |
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| Change in NIH-CPSI urinary subscale at week 4 |
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| Change in NIH-CPSI urinary subscale at week 5 |
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| Change in NIH-CPSI urinary subscale at week 6 |
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| Change in NIH-CPSI urinary subscale at week 7 |
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| Change in NIH-CPSI urinary subscale at week 8 |
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| Change in NIH-CPSI urinary subscale at week 20 |
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| Change in NIH-CPSI urinary subscale at week 32 |
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| Change in NIH-CPSI quality of life subscale at week 1 |
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| Change in NIH-CPSI quality of life subscale at week 2 |
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| Change in NIH-CPSI quality of life subscale at week 3 |
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| Change in NIH-CPSI quality of life subscale at week 4 |
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| Change in NIH-CPSI quality of life subscale at week 5 |
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| Change in NIH-CPSI quality of life subscale at week 6 |
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| Change in NIH-CPSI quality of life subscale at week 7 |
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| Change in NIH-CPSI quality of life subscale at week 8 |
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| Change in NIH-CPSI quality of life subscale at week 20 |
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| Change in NIH-CPSI quality of life subscale at week 32 |
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| Week 8 |
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| Week 20 |
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| Week 32 |
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| Week 32 |
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| Week 20 |
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| Week 32 |
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| Week 32 |
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| Week 4 : Moderately improved |
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| Week 4 : Slightly improved |
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| Week 4 : No change |
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| Week 4 : Slightly worsened |
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| Week 4 : Moderately worsened |
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| Week 4 : Markedly worsened |
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| Week 8 : Markedly improved |
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| Week 8 : Moderately improved |
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| Week 8 : Slightly improved |
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| Week 8 : No change |
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| Week 8 : Slightly worsened |
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| Week 8 : Moderately worsened |
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| Week 8 : Markedly worsened |
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| Week 20 : Markedly improved |
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| Week 20 : Moderately improved |
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| Week 20 : Slightly improved |
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| Week 20 : No change |
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| Week 20 : Slightly worsened |
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| Week 20 : Moderately worsened |
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| Week 20 : Markedly worsened |
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| Week 32 : Markedly improved |
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| Week 32 : Moderately improved |
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| Week 32 : Slightly improved |
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| Week 32 : No change |
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| Week 32 : Slightly worsened |
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| Week 32 : Moderately worsened |
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| Week 32 : Markedly worsened |
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| Changes in peak urinary flow rate at week 32 |
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| Changes in average urinary flow rate at week 8 |
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| Changes in average urinary flow rate at week 32 |
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| Unclear |
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| Do you think acupuncture will be helpful to improve your CP/CPPS symptoms? |
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