Chronic ProstatitisNCT03641807
Different Modes of Assessment on Acupuncture Effect on Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
A study testing Acupuncture in people with Chronic Prostatitis and Chronic Pelvic Pain Syndrome, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 4 sites in China.
Trial summary
Background: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common disorder. Some studies have indicated that acupuncture may ameliorate the symptoms of CP/CPPS. However, results are varied and range widely, perhaps due to different modes of assessment including timepoints, places of assessment, and… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Chronic Prostatitis, Chronic Pelvic Pain Syndrome
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 4 sitesChina
- Study dates
- 1 Nov 2018to 30 Oct 2021
- 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
- meet the diagnostic criteria according to the NIH CP/CPPS consensus: discomfort or pain in the pelvic region for at least 3 months in the previous 6 months
- 18-50 years
- NIH-CPSI total score ≥15
Who cannot join
- Urologic disease
- Residual urine volume ≥100 milliliter (mL)
- Qmax ≤15mL/s
- Use 5-alpha reductase inhibitor, alpha-blockers, antibiotics or any other prostatitis-specific medication during previous 1 month
- Diseases that influence urologic symptoms are multiple sclerosis, multiple system atrophy, stroke, Alzheimer disease, Parkinson's disease, spinal cord injury, cauda equina injury, and sexually transmitted disease
- Any acute disease or severe disease requiring treatment
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
The First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan
Wei Zhang
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Ning Li
- Recruiting
Hengyang Hospital Affiliated to Hunan University of Chinese Medicine
Hengyang, Hunan
Zenghui Yue
- Recruiting
Yantai Hospital of Traditional Chinese Medicine
Yantai, Shandong
Zhiwei Zang
About this study
Official title: The Comparison of Three Different Modes of Assessment on Acupuncture Effect on Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome: a Study Protocol for a Randomized Controlled Trial
Background: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common disorder. Some studies have indicated that acupuncture may ameliorate the symptoms of CP/CPPS. However, results are varied and range widely, perhaps due to different modes of assessment including timepoints, places of assessment, and especially subjective scales. We propose to determine the efficacy of acupuncture relative to sham acupuncture for patients with CP/CPPS, and compare different modes of assessment regarding the therapeutic effects of acupuncture.
Methods: Sixty patients with CP/CPPS will be randomly assigned to receive either acupuncture or sham-acupuncture (30 patients, each). Treatment will be conducted 3 times/week, for 4 weeks. The primary outcomes will each be the change from baseline of the total NIH (National Institutes of Health) CPSI (Chronic Prostatitis Symptom Index) score associated with 3 modes of assessment: Mode 1, the scale recorded at the hospital within 10minutes after the last session of 4 weeks of acupuncture treatment, in the company of the outcome assessors; Mode 2, the scale recorded the same day, but not at the hospital; and Mode 3, the scale recorded at the hospital 1 to 3 days after the last acupuncture session. The 3 key secondary outcomes include will be the 3 modes assessment of the changes from baseline of the NIH-CPSI total scores in the acupuncture group at week 4 after treatment. Analysis was by intention-to-treat, and multiplicity was controlled for with a step-down closed-testing procedure.
- Conditions
- Chronic Prostatitis, Chronic Pelvic Pain Syndrome
- Being tested
- Acupuncture, Sham acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Bilateral BL23, BL33, BL35 and SP6 will be inserted using Hwato-brand disposable acupuncture needles. With patients prone, after routine sterilization, bilateralBL33 will be inserted to a depth of 50 to 60mm with a 30° to 45° angle in an inferomedial direction using needles (0.30mm in diameter, 75mm in length). Bilateral BL35 will be inserted to a depth of 50 to 60mm with a slightly superolateral direction using needles (0.30mm in diameter, 75mm in length). BL23 and SP6 will be inserted vertically to a depth of 25 to 30mm using needles (0.30mm in diameter, 40mm in length). Manipulation of the needles by lifting and thrusting combined with twirling and rotating evenly will be performed until deqi occurs, defined as a sensation of soreness, numbness, heaviness, and ache. Manipulations will be applied every 10minutes and each session will last for 30minutes.
Sham acupunctureOther
Bilateral sham BL 23, BL 33, BL 35 (15mmto BL23, BL33, and BL35) and SP6 (10mmto SP6) will be inserted by needles (0.20mm in diameter, 25mm in length) to a depth of 2 to 3mm without manipulation.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Not described Receives: Other: Acupuncture |
| Sham acupuncture | Sham comparator | Not described Receives: Other: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in total score of National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) measured by the assessment of mode 1
The National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) has a total score range from 0 to 43 and higher scores indicate more severe symptoms. The 9 items of this scale are stratified into 3 domains which are pain/discomfort (location/type, frequency and severity, 0-21 points), urinary symptoms (10 points) and quality of life (0-12 points). Mode 1, the scale is recorded at the hospital within 10minutes after the twelfth (last) treatment of the 4-week treatment period, in the company of the outcome assessors.
Measured: week 4
The change from baseline in total score of National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) measured by the assessment of mode 2
The National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) has a total score range from 0 to 43 and higher scores indicate more severe symptoms. The 9 items of this scale are stratified into 3 domains which are pain/discomfort (location/type, frequency and severity, 0-21 points), urinary symptoms (10 points) and quality of life (0-12 points). Mode 2, the scale is recorded the same day, but not at the hospital.
Measured: week 4
The change from baseline in total score of National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) measured by the assessment of mode 3
The National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) has a total score range from 0 to 43 and higher scores indicate more severe symptoms. The 9 items of this scale are stratified into 3 domains which are pain/discomfort (location/type, frequency and severity, 0-21 points), urinary symptoms (10 points) and quality of life (0-12 points). Mode 3, the scale is recorded at the hospital 1 to 3 days after the last acupuncture session.
Measured: 1 to 3 days after the last acupuncture session
Secondary outcomes (6)
Mode 1 of assessment of the changes from baseline of NIH-CPSI total score in the acupuncture group
The National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) has a total score range from 0 to 43 and higher scores indicate more severe symptoms. The 9 items of this scale are stratified into 3 domains which are pain/discomfort (location/type, frequency and severity, 0-21 points), urinary symptoms (10 points) and quality of life (0-12 points). Mode 1, the scale is recorded at the hospital within 10minutes after the twelfth (last) treatment of the 4-week treatment period, in the company of the outcome assessors.
Measured: week 4
Mode 2 of assessment of the changes from baseline of NIH-CPSI total score in the acupuncture group
The National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) has a total score range from 0 to 43 and higher scores indicate more severe symptoms. The 9 items of this scale are stratified into 3 domains which are pain/discomfort (location/type, frequency and severity, 0-21 points), urinary symptoms (10 points) and quality of life (0-12 points). Mode 2, the scale is recorded the same day, but not at the hospital.
Measured: week 4
Mode 3 of assessment of the changes from baseline of NIH-CPSI total score in the acupuncture group
The National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) has a total score range from 0 to 43 and higher scores indicate more severe symptoms. The 9 items of this scale are stratified into 3 domains which are pain/discomfort (location/type, frequency and severity, 0-21 points), urinary symptoms (10 points) and quality of life (0-12 points). Mode 3, the scale is recorded at the hospital 1 to 3 days after the last acupuncture session.
Measured: 1 to 3 days after the last acupuncture session
The change from baseline of subscales scores of NIH-CPSI
The National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) has a total score range from 0 to 43 and higher scores indicate more severe symptoms. The 9 items of this scale are stratified into 3 domains which are pain/discomfort (location/type, frequency and severity, 0-21 points), urinary symptoms (10 points) and quality of life (0-12 points).
Measured: week 4
The change from baseline of International Prostate Symptom Score (IPSS)
International Prostate Symptom Score (IPSS) (Hong Kong Chinese version 2) is a valid, reliable and sensitive measure to assess Chinese males with 7 questions concerning urinary symptoms and 1 question concerning quality of life [34]. Total score of IPSS ranges from 0-35 (asymptomatic to very symptomatic). Symptoms evaluated by IPSS are categorized as mild (0-7), moderate (8-19) and severe (20-35).
Measured: week 4
The proportions of participants in each response category of the Global Response Assessment (GRA)
Global Response Assessment (GRA) which is composed of 7 response categories: markedly worsened, moderately worsened, slightly worsened, no change, slightly improved, moderately improved, and markedly improved.
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start1 Nov 2018
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
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, Zhou Jing, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641807
- Sponsor's protocol ID
- 2018-098-KY
- Status last verified
- Sep 2020
- First submitted
- 14 Aug 2018
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Three Different Modes of Assessment on Acupuncture Effect on Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome: a Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03641807
- Acronym / sponsor ID
- 2018-098-KY
- Conditions
- Chronic Prostatitis, Chronic Pelvic Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 22 Aug 2018 (actual)
- 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.
Background: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common disorder. Some studies have indicated that acupuncture may ameliorate the symptoms of CP/CPPS. However, results are varied and range widely, perhaps due to different modes of assessment including timepoints, places of assessment, and especially subjective scales. We propose to determine the efficacy of acupuncture relative to sham acupuncture for patients with CP/CPPS, and compare different modes of assessment regarding the therapeutic effects of acupuncture.
Methods: Sixty patients with CP/CPPS will be randomly assigned to receive either acupuncture or sham-acupuncture (30 patients, each). Treatment will be conducted 3 times/week, for 4 weeks. The primary outcomes will each be the change from baseline of the total NIH (National Institutes of Health) CPSI (Chronic Prostatitis Symptom Index) score associated with 3 modes of assessment: Mode 1, the scale recorded at the hospital within 10minutes after the last session of 4 weeks of acupuncture treatment, in the company of the outcome assessors; Mode 2, the scale recorded the same day, but not at the hospital; and Mode 3, the scale recorded at the hospital 1 to 3 days after the last acupuncture session. The 3 key secondary outcomes include will be the 3 modes assessment of the changes from baseline of the NIH-CPSI total scores in the acupuncture group at week 4 after treatment. Analysis was by intention-to-treat, and multiplicity was controlled for with a step-down closed-testing procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: Acupuncture |
| Sham acupuncture | Sham comparator | Other: Sham acupuncture |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- meet the diagnostic criteria according to the NIH CP/CPPS consensus: discomfort or pain in the pelvic region for at least 3 months in the previous 6 months
- 18-50 years
- NIH-CPSI total score ≥15
Key exclusion criteria (6 listed)
- Urologic disease
- Residual urine volume ≥100 milliliter (mL)
- Qmax ≤15mL/s
- Use 5-alpha reductase inhibitor, alpha-blockers, antibiotics or any other prostatitis-specific medication during previous 1 month
- Diseases that influence urologic symptoms are multiple sclerosis, multiple system atrophy, stroke, Alzheimer disease, Parkinson's disease, spinal cord injury, cauda equina injury, and sexually transmitted disease
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 |
|---|---|---|
| AcupunctureBilateral BL23, BL33, BL35 and SP6 will be inserted using Hwato-brand disposable acupuncture needles. With patients prone, after routine sterilization, bilateralBL33 will be inserted to a depth of 50 to 60mm with a 30° to 45° angle in an inferomedial direction using needles (0.30mm in diameter, 75mm in length). Bilateral BL35 will be inserted to a depth of 50 to 60mm with a slightly superolateral direction using needles (0.30mm in diameter, 75mm in length). BL23 and SP6 will be inserted vertically to a depth of 25 to 30mm using needles (0.30mm in diameter, 40mm in length). Manipulation of the needles by lifting and thrusting combined with twirling and rotating evenly will be performed until deqi occurs, defined as a sensation of soreness, numbness, heaviness, and ache. Manipulations will be applied every 10minutes and each session will last for 30minutes. | Other | Acupuncture |
| Sham acupunctureBilateral sham BL 23, BL 33, BL 35 (15mmto BL23, BL33, and BL35) and SP6 (10mmto SP6) will be inserted by needles (0.20mm in diameter, 25mm in length) to a depth of 2 to 3mm without manipulation. | Other | Sham acupuncture |
Primary outcome
The change from baseline in total score of National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) measured by the assessment of mode 1
Time frame: week 4
The National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) has a total score range from 0 to 43 and higher scores indicate more severe symptoms. The 9 items of this scale are stratified into 3 domains which are pain/discomfort (location/type, frequency and severity, 0-21 points), urinary symptoms (10 points) and quality of life (0-12 points). Mode 1, the scale is recorded at the hospital within 10minutes after the twelfth (last) treatment of the 4-week treatment period, in the company of the outcome assessors.
The change from baseline in total score of National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) measured by the assessment of mode 2
Time frame: week 4
The National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) has a total score range from 0 to 43 and higher scores indicate more severe symptoms. The 9 items of this scale are stratified into 3 domains which are pain/discomfort (location/type, frequency and severity, 0-21 points), urinary symptoms (10 points) and quality of life (0-12 points). Mode 2, the scale is recorded the same day, but not at the hospital.
The change from baseline in total score of National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) measured by the assessment of mode 3
Time frame: 1 to 3 days after the last acupuncture session
The National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) has a total score range from 0 to 43 and higher scores indicate more severe symptoms. The 9 items of this scale are stratified into 3 domains which are pain/discomfort (location/type, frequency and severity, 0-21 points), urinary symptoms (10 points) and quality of life (0-12 points). Mode 3, the scale is recorded at the hospital 1 to 3 days after the last acupuncture session.
6 secondary outcomes
Mode 1 of assessment of the changes from baseline of NIH-CPSI total score in the acupuncture group
Time frame: week 4
Mode 2 of assessment of the changes from baseline of NIH-CPSI total score in the acupuncture group
Time frame: week 4
Mode 3 of assessment of the changes from baseline of NIH-CPSI total score in the acupuncture group
Time frame: 1 to 3 days after the last acupuncture session
The change from baseline of subscales scores of NIH-CPSI
Time frame: week 4
The change from baseline of International Prostate Symptom Score (IPSS)
Time frame: week 4
The proportions of participants in each response category of the Global Response Assessment (GRA)
Time frame: week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
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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.
4 sites 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 and Chronic Pelvic Pain Syndrome, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 4 sites 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 6 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: status not confirmed, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Zhou, Master (86-010-15650729586, zjinbj@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline in total score of National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) measured by the assessment of mode 1 (time frame: week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2020.