Trial Outcomes & Findings for Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (NCT NCT03213938)
NCT ID: NCT03213938
Last Updated: 2022-08-09
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
440 participants
Primary outcome timeframe
week 8
Results posted on
2022-08-09
Participant Flow
Participant milestones
| Measure |
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).
|
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).
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|---|---|---|
|
Overall Study
STARTED
|
220
|
220
|
|
Overall Study
COMPLETED
|
206
|
208
|
|
Overall Study
NOT COMPLETED
|
14
|
12
|
Reasons for withdrawal
| Measure |
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).
|
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).
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|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Decline to participate
|
5
|
4
|
|
Overall Study
Without reason
|
4
|
5
|
Baseline Characteristics
5 participants in the acupuncture and 4 participants in the sham acupuncture group declined to participate the trial.
Baseline characteristics by cohort
| Measure |
Acupuncture
n=220 Participants
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).
|
Sham Acupuncture
n=220 Participants
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).
|
Total
n=440 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 8.0 • n=220 Participants
|
36.1 years
STANDARD_DEVIATION 7.9 • n=220 Participants
|
35.8 years
STANDARD_DEVIATION 8.0 • n=440 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=220 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=440 Participants
|
|
Sex: Female, Male
Male
|
220 Participants
n=220 Participants
|
220 Participants
n=220 Participants
|
440 Participants
n=440 Participants
|
|
Race/Ethnicity, Customized
Han
|
213 Participants
n=215 Participants • 5 participants in the acupuncture and 4 participants in the sham acupuncture group declined to participate the trial.
|
214 Participants
n=216 Participants • 5 participants in the acupuncture and 4 participants in the sham acupuncture group declined to participate the trial.
|
427 Participants
n=431 Participants • 5 participants in the acupuncture and 4 participants in the sham acupuncture group declined to participate the trial.
|
|
Race/Ethnicity, Customized
Others
|
2 Participants
n=215 Participants • 5 participants in the acupuncture and 4 participants in the sham acupuncture group declined to participate the trial.
|
2 Participants
n=216 Participants • 5 participants in the acupuncture and 4 participants in the sham acupuncture group declined to participate the trial.
|
4 Participants
n=431 Participants • 5 participants in the acupuncture and 4 participants in the sham acupuncture group declined to participate the trial.
|
|
Region of Enrollment
China
|
220 participants
n=220 Participants
|
220 participants
n=220 Participants
|
440 participants
n=440 Participants
|
|
National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score
|
31.0 units on a scale
STANDARD_DEVIATION 4.8 • n=215 Participants • 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.
|
31.4 units on a scale
STANDARD_DEVIATION 5.2 • n=215 Participants • 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.
|
31.2 units on a scale
STANDARD_DEVIATION 5.0 • n=430 Participants • 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.
|
PRIMARY outcome
Timeframe: week 8The 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).
Outcome measures
| Measure |
Acupuncture
n=220 Participants
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).
|
Sham Acupuncture
n=220 Participants
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).
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|---|---|---|
|
Proportion of Responders at the End of 8-week
|
60.6 percentage of participants
|
36.8 percentage of participants
|
PRIMARY outcome
Timeframe: week 32The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the NIH-CPSI.
Outcome measures
| Measure |
Acupuncture
n=220 Participants
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).
|
Sham Acupuncture
n=220 Participants
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).
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|---|---|---|
|
Proportion of Responders at the End of 32-week
|
61.5 percentage of participants
|
38.3 percentage of participants
|
SECONDARY outcome
Timeframe: weeks 1-7; week 20The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the NIH-CPSI.
Outcome measures
| Measure |
Acupuncture
n=220 Participants
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).
|
Sham Acupuncture
n=220 Participants
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).
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|---|---|---|
|
Proportion of Responders at Other Time Points
Week 1
|
9.1 percentage of participants
|
8.3 percentage of participants
|
|
Proportion of Responders at Other Time Points
Week 2
|
15.2 percentage of participants
|
13.9 percentage of participants
|
|
Proportion of Responders at Other Time Points
Week 3
|
27.2 percentage of participants
|
19.8 percentage of participants
|
|
Proportion of Responders at Other Time Points
Week 4
|
39.5 percentage of participants
|
26.4 percentage of participants
|
|
Proportion of Responders at Other Time Points
Week 5
|
42.6 percentage of participants
|
24.1 percentage of participants
|
|
Proportion of Responders at Other Time Points
Week 6
|
53.0 percentage of participants
|
33.3 percentage of participants
|
|
Proportion of Responders at Other Time Points
Week 7
|
61.0 percentage of participants
|
35.3 percentage of participants
|
|
Proportion of Responders at Other Time Points
Week 20
|
64.1 percentage of participants
|
34.8 percentage of participants
|
SECONDARY outcome
Timeframe: weeks 1-8; week 20; week 32Population: 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.
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.
Outcome measures
| Measure |
Acupuncture
n=215 Participants
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).
|
Sham Acupuncture
n=214 Participants
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).
|
|---|---|---|
|
the Change From Baseline in NIH-CPSI Total Score
Week 1
|
-1.9 score on a scale
Interval -2.4 to -1.5
|
-1.3 score on a scale
Interval -1.8 to -0.9
|
|
the Change From Baseline in NIH-CPSI Total Score
Week 2
|
-2.9 score on a scale
Interval -3.4 to -2.4
|
-2.4 score on a scale
Interval -2.9 to -1.9
|
|
the Change From Baseline in NIH-CPSI Total Score
Week 3
|
-3.9 score on a scale
Interval -4.4 to -3.4
|
-3.0 score on a scale
Interval -3.5 to -2.5
|
|
the Change From Baseline in NIH-CPSI Total Score
Week 4
|
-4.8 score on a scale
Interval -5.4 to -4.3
|
-3.7 score on a scale
Interval -4.2 to -3.1
|
|
the Change From Baseline in NIH-CPSI Total Score
Week 5
|
-5.2 score on a scale
Interval -5.8 to -4.6
|
-3.7 score on a scale
Interval -4.3 to -3.2
|
|
the Change From Baseline in NIH-CPSI Total Score
Week 6
|
-5.9 score on a scale
Interval -6.5 to -5.3
|
-4.0 score on a scale
Interval -4.6 to -3.5
|
|
the Change From Baseline in NIH-CPSI Total Score
Week 7
|
-6.7 score on a scale
Interval -7.3 to -6.1
|
-4.6 score on a scale
Interval -5.2 to -4.0
|
|
the Change From Baseline in NIH-CPSI Total Score
Week 8
|
-7.4 score on a scale
Interval -8.0 to -6.8
|
-4.9 score on a scale
Interval -5.5 to -4.3
|
|
the Change From Baseline in NIH-CPSI Total Score
Week 20
|
-7.2 score on a scale
Interval -8.0 to -6.6
|
-4.5 score on a scale
Interval -5.2 to -3.9
|
|
the Change From Baseline in NIH-CPSI Total Score
Week 32
|
-7.4 score on a scale
Interval -8.1 to -6.7
|
-4.9 score on a scale
Interval -5.5 to -4.2
|
SECONDARY outcome
Timeframe: weeks 1-8; week 20; week 32Population: 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.
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.
Outcome measures
| Measure |
Acupuncture
n=215 Participants
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).
|
Sham Acupuncture
n=214 Participants
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).
|
|---|---|---|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI pain subscale at week 1
|
-0.6 score on a scale
Interval -0.9 to -0.4
|
-0.5 score on a scale
Interval -0.7 to -0.2
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI pain subscale at week 2
|
-0.8 score on a scale
Interval -1.1 to -0.6
|
-0.8 score on a scale
Interval -1.0 to -0.5
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI pain subscale at week 3
|
-1.1 score on a scale
Interval -1.4 to -0.9
|
-0.8 score on a scale
Interval -1.1 to -0.6
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI pain subscale at week 4
|
-1.6 score on a scale
Interval -1.8 to -1.3
|
-1.1 score on a scale
Interval -1.3 to -0.9
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI pain subscale at week 5
|
-1.5 score on a scale
Interval -1.7 to -1.2
|
-1.1 score on a scale
Interval -1.3 to -0.9
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI pain subscale at week 6
|
-1.8 score on a scale
Interval -2.0 to -1.5
|
-1.1 score on a scale
Interval -1.4 to -0.9
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI pain subscale at week 7
|
-2.0 score on a scale
Interval -2.3 to -1.8
|
-1.3 score on a scale
Interval -1.5 to -1.1
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI pain subscale at week 8
|
-2.1 score on a scale
Interval -2.4 to -1.9
|
-1.3 score on a scale
Interval -1.5 to -1.1
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI pain subscale at week 20
|
-2.0 score on a scale
Interval -2.3 to -1.8
|
-1.0 score on a scale
Interval -1.2 to -0.7
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI pain subscale at week 32
|
-2.0 score on a scale
Interval -2.3 to -1.8
|
-1.3 score on a scale
Interval -1.5 to -1.0
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI urinary subscale at week 1
|
-0.5 score on a scale
Interval -0.7 to -0.3
|
-0.4 score on a scale
Interval -0.6 to -0.2
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI urinary subscale at week 2
|
-0.8 score on a scale
Interval -1.0 to -0.6
|
-0.6 score on a scale
Interval -0.8 to -0.4
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI urinary subscale at week 3
|
-1.0 score on a scale
Interval -1.3 to -0.8
|
-0.9 score on a scale
Interval -1.1 to -0.7
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI urinary subscale at week 4
|
-1.3 score on a scale
Interval -1.6 to -1.1
|
-1.0 score on a scale
Interval -1.2 to -0.8
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI urinary subscale at week 5
|
-1.6 score on a scale
Interval -1.8 to -1.3
|
-1.1 score on a scale
Interval -1.3 to -0.9
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI urinary subscale at week 6
|
-1.7 score on a scale
Interval -1.9 to -1.5
|
-1.2 score on a scale
Interval -1.4 to -0.9
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI urinary subscale at week 7
|
-1.9 score on a scale
Interval -2.2 to -1.7
|
-1.3 score on a scale
Interval -1.6 to -1.1
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI urinary subscale at week 8
|
-2.1 score on a scale
Interval -2.4 to -1.9
|
-1.4 score on a scale
Interval -1.6 to -1.2
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI urinary subscale at week 20
|
-2.1 score on a scale
Interval -2.3 to -1.8
|
-1.5 score on a scale
Interval -1.7 to -1.2
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI urinary subscale at week 32
|
-2.1 score on a scale
Interval -2.4 to -1.9
|
-1.5 score on a scale
Interval -1.8 to -1.2
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI quality of life subscale at week 1
|
-0.8 score on a scale
Interval -0.9 to -0.6
|
-0.5 score on a scale
Interval -0.7 to -0.3
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI quality of life subscale at week 2
|
-1.2 score on a scale
Interval -1.4 to -1.0
|
-0.9 score on a scale
Interval -1.2 to -0.7
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI quality of life subscale at week 3
|
-1.7 score on a scale
Interval -1.9 to -1.5
|
-1.2 score on a scale
Interval -1.4 to -1.0
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI quality of life subscale at week 4
|
-1.9 score on a scale
Interval -2.2 to -1.7
|
-1.5 score on a scale
Interval -1.8 to -1.3
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI quality of life subscale at week 5
|
-2.2 score on a scale
Interval -2.4 to -1.9
|
-1.5 score on a scale
Interval -1.8 to -1.3
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI quality of life subscale at week 6
|
-2.4 score on a scale
Interval -2.7 to -2.2
|
-1.7 score on a scale
Interval -2.0 to -1.5
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI quality of life subscale at week 7
|
-2.8 score on a scale
Interval -3.0 to -2.5
|
-1.9 score on a scale
Interval -2.2 to -1.7
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI quality of life subscale at week 8
|
-3.1 score on a scale
Interval -3.4 to -2.8
|
-2.2 score on a scale
Interval -2.4 to -1.9
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI quality of life subscale at week 20
|
-3.2 score on a scale
Interval -3.5 to -2.8
|
-2.0 score on a scale
Interval -2.4 to -1.7
|
|
the Change From Baseline in NIH-CPSI Subscales
Change in NIH-CPSI quality of life subscale at week 32
|
-3.1 score on a scale
Interval -3.5 to -2.8
|
-2.1 score on a scale
Interval -2.4 to -1.8
|
SECONDARY outcome
Timeframe: week 4; week 8; week 20; week 32Population: 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.
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.
Outcome measures
| Measure |
Acupuncture
n=208 Participants
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).
|
Sham Acupuncture
n=213 Participants
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).
|
|---|---|---|
|
the Change From Baseline in the International Prostate Symptom Score (IPSS)
Week 4
|
-2.7 score on a scale
Interval -3.2 to -2.3
|
-1.7 score on a scale
Interval -2.1 to -1.2
|
|
the Change From Baseline in the International Prostate Symptom Score (IPSS)
Week 8
|
-4.4 score on a scale
Interval -4.9 to -3.9
|
-2.7 score on a scale
Interval -3.2 to -2.2
|
|
the Change From Baseline in the International Prostate Symptom Score (IPSS)
Week 20
|
-4.7 score on a scale
Interval -5.3 to -4.2
|
-3.0 score on a scale
Interval -3.6 to -2.4
|
|
the Change From Baseline in the International Prostate Symptom Score (IPSS)
Week 32
|
-4.7 score on a scale
Interval -5.4 to -4.1
|
-3.1 score on a scale
Interval -3.8 to -2.5
|
SECONDARY outcome
Timeframe: week 8; week 20; week 32Population: 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.
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.
Outcome measures
| Measure |
Acupuncture
n=206 Participants
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).
|
Sham Acupuncture
n=208 Participants
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).
|
|---|---|---|
|
the Change From Baseline in the Hospital Anxiety and Depression Scale (HADS)
Week 8
|
-1.9 score on a scale
Interval -2.5 to -1.4
|
-0.8 score on a scale
Interval -1.3 to -0.3
|
|
the Change From Baseline in the Hospital Anxiety and Depression Scale (HADS)
Week 20
|
-2.4 score on a scale
Interval -3.0 to -1.8
|
-0.6 score on a scale
Interval -1.3 to 0.0
|
|
the Change From Baseline in the Hospital Anxiety and Depression Scale (HADS)
Week 32
|
-2.8 score on a scale
Interval -3.5 to -2.2
|
-0.5 score on a scale
Interval -1.2 to 0.1
|
SECONDARY outcome
Timeframe: week 8; week 20; week 32Population: 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.
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.
Outcome measures
| Measure |
Acupuncture
n=206 Participants
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).
|
Sham Acupuncture
n=207 Participants
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).
|
|---|---|---|
|
the Change From Baseline in the International Index of Erectile Function 5 (IIEF-5)
Week 8
|
0.8 score on a scale
Interval 0.2 to 1.3
|
0.3 score on a scale
Interval -0.3 to 0.8
|
|
the Change From Baseline in the International Index of Erectile Function 5 (IIEF-5)
Week 20
|
0.7 score on a scale
Interval 0.2 to 1.3
|
0.2 score on a scale
Interval -0.3 to 0.7
|
|
the Change From Baseline in the International Index of Erectile Function 5 (IIEF-5)
Week 32
|
1.0 score on a scale
Interval 0.4 to 1.6
|
0.4 score on a scale
Interval -0.1 to 1.0
|
SECONDARY outcome
Timeframe: week 8; week 20; week 32Population: 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.
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.
Outcome measures
| Measure |
Acupuncture
n=206 Participants
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).
|
Sham Acupuncture
n=208 Participants
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).
|
|---|---|---|
|
the Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire
Week 8
|
0.06 units on a scale
Interval 0.05 to 0.07
|
0.03 units on a scale
Interval 0.02 to 0.04
|
|
the Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire
Week 20
|
0.06 units on a scale
Interval 0.05 to 0.07
|
0.03 units on a scale
Interval 0.02 to 0.04
|
|
the Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire
Week 32
|
0.06 units on a scale
Interval 0.05 to 0.08
|
0.03 units on a scale
Interval 0.02 to 0.04
|
SECONDARY outcome
Timeframe: week 4; week 8; week 20; week 32Population: 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.
GRA consists of 7 response categories: markedly worsened, moderately worsened, slightly worsened, no change, slightly improved, moderately improved, and markedly improved.
Outcome measures
| Measure |
Acupuncture
n=208 Participants
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).
|
Sham Acupuncture
n=213 Participants
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).
|
|---|---|---|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 4 : Markedly improved
|
15.9 percentage of participants
|
7.5 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 4 : Moderately improved
|
24.0 percentage of participants
|
14.6 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 4 : Slightly improved
|
46.6 percentage of participants
|
50.7 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 4 : No change
|
13.0 percentage of participants
|
25.4 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 4 : Slightly worsened
|
0.5 percentage of participants
|
1.9 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 4 : Moderately worsened
|
0 percentage of participants
|
0 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 4 : Markedly worsened
|
0 percentage of participants
|
0 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 8 : Markedly improved
|
30.6 percentage of participants
|
8.7 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 8 : Moderately improved
|
36.4 percentage of participants
|
27.9 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 8 : Slightly improved
|
27.2 percentage of participants
|
40.9 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 8 : No change
|
5.3 percentage of participants
|
19.2 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 8 : Slightly worsened
|
0.5 percentage of participants
|
3.4 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 8 : Moderately worsened
|
0 percentage of participants
|
0 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 8 : Markedly worsened
|
0 percentage of participants
|
0 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 20 : Markedly improved
|
24.3 percentage of participants
|
6.7 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 20 : Moderately improved
|
24.3 percentage of participants
|
17.8 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 20 : Slightly improved
|
27.7 percentage of participants
|
31.7 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 20 : No change
|
19.4 percentage of participants
|
30.3 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 20 : Slightly worsened
|
4.4 percentage of participants
|
12.0 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 20 : Moderately worsened
|
0 percentage of participants
|
1.4 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 20 : Markedly worsened
|
0 percentage of participants
|
0 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 32 : Markedly improved
|
22.3 percentage of participants
|
8.2 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 32 : Moderately improved
|
24.8 percentage of participants
|
16.8 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 32 : Slightly improved
|
27.2 percentage of participants
|
29.3 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 32 : No change
|
20.9 percentage of participants
|
32.7 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 32 : Slightly worsened
|
4.4 percentage of participants
|
8.7 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 32 : Moderately worsened
|
0.5 percentage of participants
|
3.9 percentage of participants
|
|
the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)
Week 32 : Markedly worsened
|
0 percentage of participants
|
0.5 percentage of participants
|
SECONDARY outcome
Timeframe: weeks 8 and 32Population: 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.
Outcome measures
| Measure |
Acupuncture
n=195 Participants
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).
|
Sham Acupuncture
n=198 Participants
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).
|
|---|---|---|
|
the Change for Peak and Average Urinary Flow Rate From Baseline
Changes in peak urinary flow rate at week 8
|
0.6 ml/s
Interval -0.3 to 1.6
|
0.7 ml/s
Interval -0.2 to 1.6
|
|
the Change for Peak and Average Urinary Flow Rate From Baseline
Changes in peak urinary flow rate at week 32
|
0.5 ml/s
Interval -0.4 to 1.3
|
-0.6 ml/s
Interval -1.4 to 0.2
|
|
the Change for Peak and Average Urinary Flow Rate From Baseline
Changes in average urinary flow rate at week 8
|
0.6 ml/s
Interval 0.1 to 1.1
|
0.4 ml/s
Interval -0.1 to 0.9
|
|
the Change for Peak and Average Urinary Flow Rate From Baseline
Changes in average urinary flow rate at week 32
|
0.5 ml/s
Interval 0.1 to 1.0
|
-0.2 ml/s
Interval -0.6 to 0.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baselinePopulation: 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.
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.
Outcome measures
| Measure |
Acupuncture
n=213 Participants
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).
|
Sham Acupuncture
n=215 Participants
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).
|
|---|---|---|
|
Expectation Assessment
Do you believe acupuncture is effective for treating diseases in general? · Yes
|
167 Participants
|
165 Participants
|
|
Expectation Assessment
Do you believe acupuncture is effective for treating diseases in general? · No
|
0 Participants
|
1 Participants
|
|
Expectation Assessment
Do you believe acupuncture is effective for treating diseases in general? · Unclear
|
46 Participants
|
49 Participants
|
|
Expectation Assessment
Do you think acupuncture will be helpful to improve your CP/CPPS symptoms? · Yes
|
156 Participants
|
150 Participants
|
|
Expectation Assessment
Do you think acupuncture will be helpful to improve your CP/CPPS symptoms? · No
|
0 Participants
|
1 Participants
|
|
Expectation Assessment
Do you think acupuncture will be helpful to improve your CP/CPPS symptoms? · Unclear
|
57 Participants
|
64 Participants
|
Adverse Events
Acupuncture
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Sham Acupuncture
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Acupuncture
n=220 participants at risk
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).
|
Sham Acupuncture
n=220 participants at risk
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).
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Subcutaneous hematoma
|
4.1%
9/220 • 34 weeks
|
2.3%
5/220 • 34 weeks
|
|
Infections and infestations
Localized infection
|
0.45%
1/220 • 34 weeks
|
0.00%
0/220 • 34 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.45%
1/220 • 34 weeks
|
0.00%
0/220 • 34 weeks
|
|
General disorders
Cold
|
3.2%
7/220 • 34 weeks
|
2.7%
6/220 • 34 weeks
|
|
General disorders
Fever
|
0.45%
1/220 • 34 weeks
|
0.45%
1/220 • 34 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillitis
|
0.00%
0/220 • 34 weeks
|
0.45%
1/220 • 34 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/220 • 34 weeks
|
0.45%
1/220 • 34 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.45%
1/220 • 34 weeks
|
0.00%
0/220 • 34 weeks
|
|
Gastrointestinal disorders
Acute gastritis
|
0.00%
0/220 • 34 weeks
|
0.45%
1/220 • 34 weeks
|
Additional Information
Zhishun Liu
Guang'anmen Hospital, China Academy Chinese Medical Sciences
Phone: +86 010 88002331
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place