Chronic ProstatitisNCT02588274
Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome
A study testing Acupuncture in people with Chronic Prostatitis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) affects many adult men worldwide. So far, available therapies offer little or no proven benefit to CP/CPPS. The investigators design and implement this study is to assess efficacy of acupuncture therapy performed in the CP/CPPS . Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Chronic Prostatitis
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- History of pain perceived in the region of the prostate and absence of other lower urinary tract pathology for a minimum of 3 out of the past 6 months. In addition, associated lower urinary tract symptoms, sexual function, psychological factors should be addressed.
- Age 18 to 50 years
- NIH Chronic Prostatitis Symptom Index (NIH-CPSI) total score≥ 15 (scale 0-43, and 0 means no symptom).
Who cannot join
- Other urologic disease (for example, acute prostatitis, bacterial prostatitis, benign prostatic hyperplasia, prostate cancer, urinary tuberculosis, urinary tract infection)
- Serious or acute diseases with heart, liver, kidney and blood system.
- Patients who had received acupuncture or medication (including alpha-blockers or pain killers) treatment in the week prior to the baseline assessment
- Patients without telephone number who cannot be connected during the follow-up
Trial locations and contacts
1 site in 1 country.
China1 site
Guang'anmen Hospital, China Academy of Chinese Medical Science
Beijing, Beijing Municipality, 100053
About this study
Official title: Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome: Study Protocol for a Randomized, Placebo-controlled Trial
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) affects many adult men worldwide. So far, available therapies offer little or no proven benefit to CP/CPPS. The investigators design and implement this study is to assess efficacy of acupuncture therapy performed in the CP/CPPS .
Read the detailed description
This study is a multi-center, placebo-controlled, randomized trial comparing acupuncture and placebo needle among patients with CP/CPPS, which will be conducted in Guang'anmen Hospital of China Academy of Chinese Medical Sciences and Yantai Chinese Medicine Hospital from November 2015 to May 2017. 68 patients will be recruited in total through the advertisements spreading by newspaper, television and internet. After participants have completed a baseline evaluation and meet the selection criteria, one professional statistician uninvolved with treatment and data collection will assigns the participants by using a computer generated, blocked random allocation sequence randomly and acupuncturist will be blinded to the process of randomized assignment.Treatment group will use acupuncture and control group will use placebo needle, for treatment, Zhongliao (BL 33), Shenshu (BL 23), Guiyang (BL 35), Sanyinjiao (SP 6) acupuncture points will be used, the treatment sessions are 24 weeks after baseline, 3 times a week and each time the patients will accept a 30 minutes treatment, to control group, participants will receive placebo needle treatment at the same acupuncture points and the duration and frequency of sessions are same to the real acupuncture group. The primary outcome measure of this study is the decreasing in (National Institutes of Health Chronic Prostatitis Symptom Index) NIH-CPSI total score from baseline to week 8, and secondary outcomes include NIH-CPSI sub scales at week, (International Prostate Symptom Score) IPSS total score, Global response assessment, expectation degree and satisfaction degree. The first three secondary outcomes will be measured at 4,8,20 and 32 weeks, expectation degree will be measured at baseline, and the satisfaction degree will be measure at 8, 20, 32 weeks.
- Conditions
- Chronic Prostatitis
- Being tested
- Acupuncture, placebo needle
- Keywords
- Chronic prostatitis, chronic pelvic pain syndrome, acupuncture, placebo needle, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Also called needle
Acupuncture is one of the oldest standardized neuromodulatory therapies. The method of acupuncture treatment involves the insertion of needles in acupuncture points according to a system of channels and meridians. The needles are stimulated by manual manipulation, electrical stimulation or heat. The general theory of acupuncture is based on the premise that there are patterns of energy flow through the body that are essential for health. Disruptions of this flow are believed to be responsible for disease. Acupuncture may correct imbalances of flow at identifiable points close to the skin.
placebo needleDevice
Placebo needle is a type of control without skin penetration based on the application of placebo needles with blunt needle tips.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Zhongliao (BL 33), Shenshu (BL 23), Huiyang (BL 35), and Sanyinjiao (SP 6) acupuncture points (Table 1). After patients are in prone position with relax, the investigators will use 75% alcohol pads to sterile the skin around the acupuncture points, and then insert steel needles (Huatuo, Suzhou, China 0.3mm*40mm/0.3mm*75mm) into the acupuncture points. For bilateral Zhongliao (BL 33), the needle will be inserted into about 50-60mm with 45 degree, for Huiyang (BL 35), the needle will be inserted into 50-60mm. for Shenshu (BL 23) and Sanyinjiao (SP 6), the needles will be inserted vertically to a depth of 25-30 mm. The treatment sessions are 24 after baseline, 3 times a week, and the each time the patients will accept a 30 minutes treatment. Receives: Device: Acupuncture |
| placebo needle | Placebo comparator | The participants in placebo needle group will receive placebo needle at the same acupuncture points to treatment group. Investigators will use a sort of blunt needle that cannot penetrate skin and stimulate deep tissues while the thrusting and twisting manipulation will be used by acupuncturists to mock the treatment procedure and blind the patients. The duration and frequency of sessions are same to the treatment group. Receives: Device: placebo needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIH-CPSI total score and change from baseline
Measured: baseline, week 1-8
Secondary outcomes (6)
NIH-CPSI subscales score
Measured: Baseline, week 4,8,20,32
NIH-CPSI total score in follow-up
Measured: week 20,32
IPSS total score and change from baseline
Measured: baseline, week 4,8,20,32
Global response assessment improvement
Measured: week 4,8,20,32
expectations degree
The expectations that acupuncture might help participants CP/CPPS at baseline. This scale includes two brief questions to investigate whether patients believe acupuncture treatment and if acupuncture may help CP/CPPS. The investigators designed this scale and the investigators want to explore the impact of variable that are potentially associated with placebo effects, namely will participants' expectations be treatment effect modifier?
Measured: baseline
Degree of satisfaction
The investigators designed this scale, which include 5 grades answer from 0 to 4, means "not at all" "a little" "Quite satisfied" "satisfaction" "very satisfaction"and the investigators want to use this to test blinding of participants.
Measured: week 8,20,32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic ProstatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qin Zongshi, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Zhishun Liu, PhD, Principal investigator, Guang'anmen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588274
- Sponsor's protocol ID
- 2015S102
- Status last verified
- Feb 2019
- First submitted
- 20 Oct 2015
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Qin Z, Zang Z, Wu J, Zhou J, Liu Z. Efficacy of acupuncture for chronic prostatitis/chronic pelvic pain syndromes: study protocol for a randomized, sham acupuncture-controlled trial. BMC Complement Altern Med. 2016 Nov 7;16(1):440. doi: 10.1186/s12906-016-1428-y.
PubMed 27821109
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome: Study Protocol for a Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02588274
- Acronym / sponsor ID
- 2015S102
- Conditions
- Chronic Prostatitis
- Keywords
- Chronic prostatitis, chronic pelvic pain syndrome, acupuncture, placebo needle, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) affects many adult men worldwide. So far, available therapies offer little or no proven benefit to CP/CPPS. The investigators design and implement this study is to assess efficacy of acupuncture therapy performed in the CP/CPPS .
Detailed description
This study is a multi-center, placebo-controlled, randomized trial comparing acupuncture and placebo needle among patients with CP/CPPS, which will be conducted in Guang'anmen Hospital of China Academy of Chinese Medical Sciences and Yantai Chinese Medicine Hospital from November 2015 to May 2017. 68 patients will be recruited in total through the advertisements spreading by newspaper, television and internet. After participants have completed a baseline evaluation and meet the selection criteria, one professional statistician uninvolved with treatment and data collection will assigns the participants by using a computer generated, blocked random allocation sequence randomly and acupuncturist will be blinded to the process of randomized assignment.Treatment group will use acupuncture and control group will use placebo needle, for treatment, Zhongliao (BL 33), Shenshu (BL 23), Guiyang (BL 35), Sanyinjiao (SP 6) acupuncture points will be used, the treatment sessions are 24 weeks after baseline, 3 times a week and each time the patients will accept a 30 minutes treatment, to control group, participants will receive placebo needle treatment at the same acupuncture points and the duration and frequency of sessions are same to the real acupuncture group. The primary outcome measure of this study is the decreasing in (National Institutes of Health Chronic Prostatitis Symptom Index) NIH-CPSI total score from baseline to week 8, and secondary outcomes include NIH-CPSI sub scales at week, (International Prostate Symptom Score) IPSS total score, Global response assessment, expectation degree and satisfaction degree. The first three secondary outcomes will be measured at 4,8,20 and 32 weeks, expectation degree will be measured at baseline, and the satisfaction degree will be measure at 8, 20, 32 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Device: AcupunctureZhongliao (BL 33), Shenshu (BL 23), Huiyang (BL 35), and Sanyinjiao (SP 6) acupuncture points (Table 1). After patients are in prone position with relax, the investigators will use 75% alcohol pads to sterile the skin around the acupuncture points, and then insert steel needles (Huatuo, Suzhou, China 0.3mm*40mm/0.3mm*75mm) into the acupuncture points. For bilateral Zhongliao (BL 33), the needle will be inserted into about 50-60mm with 45 degree, for Huiyang (BL 35), the needle will be inserted into 50-60mm. for Shenshu (BL 23) and Sanyinjiao (SP 6), the needles will be inserted vertically to a depth of 25-30 mm. The treatment sessions are 24 after baseline, 3 times a week, and the each time the patients will accept a 30 minutes treatment. |
| placebo needle | Placebo comparator | Device: placebo needleThe participants in placebo needle group will receive placebo needle at the same acupuncture points to treatment group. Investigators will use a sort of blunt needle that cannot penetrate skin and stimulate deep tissues while the thrusting and twisting manipulation will be used by acupuncturists to mock the treatment procedure and blind the patients. The duration and frequency of sessions are same to the treatment group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- History of pain perceived in the region of the prostate and absence of other lower urinary tract pathology for a minimum of 3 out of the past 6 months. In addition, associated lower urinary tract symptoms, sexual function, psychological factors should be addressed.
- Age 18 to 50 years
- NIH Chronic Prostatitis Symptom Index (NIH-CPSI) total score≥ 15 (scale 0-43, and 0 means no symptom).
Key exclusion criteria (4 listed)
- Other urologic disease (for example, acute prostatitis, bacterial prostatitis, benign prostatic hyperplasia, prostate cancer, urinary tuberculosis, urinary tract infection)
- Serious or acute diseases with heart, liver, kidney and blood system.
- Patients who had received acupuncture or medication (including alpha-blockers or pain killers) treatment in the week prior to the baseline assessment
- Patients without telephone number who cannot be connected during the follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAlso: needleAcupuncture is one of the oldest standardized neuromodulatory therapies. The method of acupuncture treatment involves the insertion of needles in acupuncture points according to a system of channels and meridians. The needles are stimulated by manual manipulation, electrical stimulation or heat. The general theory of acupuncture is based on the premise that there are patterns of energy flow through the body that are essential for health. Disruptions of this flow are believed to be responsible for disease. Acupuncture may correct imbalances of flow at identifiable points close to the skin. | Device | Acupuncture |
| placebo needlePlacebo needle is a type of control without skin penetration based on the application of placebo needles with blunt needle tips. | Device | placebo needle |
Primary outcome
NIH-CPSI total score and change from baseline
Time frame: baseline, week 1-8
6 secondary outcomes
NIH-CPSI subscales score
Time frame: Baseline, week 4,8,20,32
NIH-CPSI total score in follow-up
Time frame: week 20,32
IPSS total score and change from baseline
Time frame: baseline, week 4,8,20,32
Global response assessment improvement
Time frame: week 4,8,20,32
expectations degree
Time frame: baseline
Degree of satisfaction
Time frame: week 8,20,32
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 27821109Qin Z, Zang Z, Wu J, Zhou J, Liu Z. Efficacy of acupuncture for chronic prostatitis/chronic pelvic pain syndromes: study protocol for a randomized, sham acupuncture-controlled trial. BMC Complement Altern Med. 2016 Nov 7;16(1):440. doi: 10.1186/s12906-016-1428-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhishun Liu, PhD principal investigator
Guang'anmen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Chronic Prostatitis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIH-CPSI total score and change from baseline (time frame: baseline, week 1-8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02588274, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.