Chronic Prostatitis With Chronic Pelvic Pain SyndromeNCT05075551

Analyzing the Brain Alterations of Acupuncture on Patients With CP/CPPS Evaluated by fMRI

A study testing Acupuncture and fMRI scan in people with Chronic Prostatitis With Chronic Pelvic Pain Syndrome, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 20 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Chronic Prostatitis With Chronic Pelvic Pain Syndrome
What is being tested?: Acupuncture and fMRI scan
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 500 participants
Where: 1 siteChina
Study dates: 5 Jan 2022to 31 Dec 2023
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 20 to 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

(1)The clinical diagnosis of CP/CPPS is exclusionary diagnosis.The main steps of diagnosing CP/CPPS are follwing: T
he chief complaint is long-term recurrent pain or discomfort of lumbosacral and perianal distension in the lower abdomen of the external perineum genital area and the superior pubic area (more than 3 months).
Bacterial prostatitis will be eliminated by routine culture of prostatic fluid and urine culture before and after prostatic massage.
Urinary tract infection will be ruled out by routine urinalysis and sediment examination.
(2)Total score of NIH-CPSI ≥ 15.

Who cannot join

The participants would be excluded if they got any acute or chronic infectious disease, other chronic pain diseases, internal organic diseases, history of malignant tumors, and chronic diseases that might contribute to peripheral nerve injury like diabetes mellitus and hypertension.
Prostate changes will be observed by prostate ultrasound and other urogenital and pelvic space-occupying lesions will be excluded.
Contraindications of fMRI scan like claustrophobia and denture implantation status are also considered.

Trial locations and contacts

1 site in 1 country.

China1 site

Department of Acupuncture, LongHua Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: Analyzing the Brain Alterations of Acupuncture on Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome Evaluated by fMRI: Study Protocol for a Randomized Trial

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is one of the most common diseases in urology, but its pathogenesis remains unclear and the effective therapy lacks. As a kind of chronic pain which the patients suffered for more than 3 months, CP/CPPS could be alleviated by acupuncture. Functional magnetic resonance imaging (fMRI) and higher magnetic field strengths could enable scientists to investigate the brain accurately and non-invasively during every stage of chronic pain.To avoid placebo effect, sham acupuncture would be also enrolled.Herein, by the utilization of fMRI in resting-state, we investigated the influence on patients' brain alterations after the patients accepted the treatment of acupuncture.

Read the detailed description

A two (participant and assessor) blind, two-arm parallel, randomized controlled trial will be conducted. Sixty patients with CP/CPPS will be recruited from Huashan Hospital, Shanghai, and thirty healthy volunteers will be recruited as the healthy control group by advertisement. Patients will be randomly assigned into one of two intervention groups: acupuncture group and sham acupuncture group. The ratio of healthy control (n = 30), acupuncture group (n = 30) and sham acupuncture group (n = 30) will be 1:1:1. Sanyinjiao (SP6), Zhibian (BL54), Shenshu (BL23), and Huiyang (BL35) are chosen as acupoints for both acupuncture group and sham acupuncture group (Park sham device). The course of treatment is 2 times a week in three months (totally 24 times). The group of healthy control will get only once fMRI scan while the group of patients will get fMRI scan week 0 (before treatment), week 12 (after treatment) and week 36 (following up). Every time the participants receive the fMRI scan, they will be asked to finish the clinical scales. The primary outcome will be the change in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score from baseline to week 12 and week 36. Secondary outcomes will include the changes of Hospital Anxiety and Depression Scale, International Prostate Symptom Score, International Index of Erectile Function, Self-Esteem Scale, Social Support Rating Scale and Numeric Rating Scale and brain functional activated or inactivated regions.

Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Being tested: Acupuncture, Sham acupuncture, fMRI scan
Keywords: Chronic Prostatitis/Chronic Pelvic Pain Syndrome, Functional Magnetic Resonance Imaging, Acupuncture
Medical subject headings: Prostatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcupunctureDevice
Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used.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; BL23 is in the sacral region, in the second posterior sacral foramen; BL54 is in the fourth posterior sacral foramen, 3 cun beside the median sacral crest; BL35 is in the buttock region, 0.5 cun lateral to the extremity of the coccyx.
Sham acupunctureDevice
Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used.These volunteers will receive relatively shallow needling at bilateral sham SP6, BL54, BL23 and BL35. This treatment gets involved in the same duration and frequency of sessions, but the treatment was delivered superficially at non-acupuncture points 10 mm to the lateral of corresponding acupuncture and not above a meridian line (10mm to SP6, BL54, BL23 and BL35).The same equipment of fMRI scanner will be used.
fMRI scanOther
Both two group will get fMRI scan week 0 (before treatment), week 12 (after treatment) and week 36 (following up). The resting-state fMRI data will be obtained by using a 3.0T GE MR 750 MRI scanner with an eight-channel phase array head coil at the Huashan Hospital, Shanghai. The high resolution T1-weighted magnetic resonance images will be collected by a three-dimensional fast spoiled gradient-echo dual-echo sequence [repetition time (TR) = 8100 ms; echo time (TE) = 3.1 ms; FA = 8 deg; matrix=256 × 256; field of view (FOV)=25.6× 25.6 cm2; slice thickness=1 mm; no gap and 156 slices]. The whole resting state fMRI data will be acquired by using a gradient-recalled echo-planar imaging pulse sequence (TR/TE = 2,000/30 ms; FA = 90°; acquisition matrix = 64×64; FOV = 22×22 cm2; slice thickness= 4 mm; 43 slices and total 240 time points; no gap).

Study groups in NCT05075551
Study group	Role	What they receive
Acupuncture	Experimental	Before participants accept the treatment, they are acquired to finish the clinical scales (including NIH-CPSI scale, HADS, VAS, SSRS, SES, IPSS and QoL) and then get the fMRI scan. Hwato brand disposable acupuncture needles will be used. Sanyinjiao (SP6), Zhibian (BL54), Shenshu (BL23), and Huiyang (BL35) are selected as acupoints. The course of treatment is 2 times a week in three months (totally 24 times). At the ending of the treatment, all the volunteers will be asked to finish the clinical scales and get the fMRI scan again. As the step of following up, all the patients will be asked to finish the clinical scales and get the fMRI scan again to evaluate the efficacy of avoiding the recurrence of acupuncture. Receives: Device: Acupuncture; Other: fMRI scan
Sham Acupuncture	Sham comparator	In the sham acupuncture group, these volunteers will receive relatively shallow needling at bilateral sham SP6, BL54, BL23, and BL35. This treatment gets involved in the same duration and frequency of sessions, but the treatment was delivered superficially at non-acupuncture points 10 mm to the lateral of corresponding acupuncture and not above a meridian line (10mm to SP6, BL54, BL23 and BL35). The Hwato brand disposable acupuncture needles will be inserted with a depth of 2-3 mm without any manipulation.The procedure of finishing scales and get fMRI scanning will be the same as the group of acupuncture. Receives: Device: Sham acupuncture; Other: fMRI scan

What is being measured

The primary outcome is the main question the study is designed to answer.

The change in the NIH-CPSI total score at the end of week 12 and week 36
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) , compared with the baseline in week 0.It is because a decline of at least 6 points in NIH-CPSI is acknowledged as the minimal clinically important difference. The NIH-CPSI is a self-assessment form with nine items, which the main components encompass pain with 4 items focused on location, severity and frequency, urinary function embracing one irritative item and one obstructive item, and quality of life impact with 3 items about the effect of symptoms on daily activities. The NIH-CPSI provides a systematized and unanimously accepted outcome measuring tool, and it is widely used in clinical trials, along with in the evidence-based evaluation of treatment effects.
Measured: week 0, week 12 and week 36

Secondary outcomes (9)

The alterations in brain of patients with CP/CPPS measured by fMRI when finishing the whole treatment
By analysis of fMRI data, the potential alterations of treatment effect in brain will be concluded.
Measured: week 12
The alterations in brain of patients with CP/CPPS measured by fMRI in the following-up (24weeks after treatment)
By analysis of fMRI data, the potential alterations of recurrence in brain will be concluded.
Measured: week 36
the change from baseline in NIH-CPSI subscales
The alterations of NIH-CPSI subscales will provide the certain efficacy in the symptoms of CP/CPPS.
Measured: week 0, week 12, week 36
the change from baseline in the International Prostate Symptom Score (IPSS)
These changes will reveal the efficacy of acupuncture in the aspect of lower urinary tract symptoms.To detailly describe the symptoms of lower urinary tract, except for the NIH-CPSI, we will independently apply the International Prostate Symptom Score (IPSS). The IPSS covers seven symptom questions and one health-related quality of life (QoL) question.
Measured: week 0, week 12, week 36
the change from baseline in the Visual Analogue Scale (VAS)
These changes will reveal the efficacy of acupuncture in the aspect of pain.For pain assessment, the Numeric Rating Scale (NRS) is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0 -10 integers) that best reflects the intensity and severity of pain.
Measured: week 0, week 12, week 36
the change from baseline in the Self-Esteem Scale (SES).
These changes will reveal the efficacy of acupuncture in the aspect of internal self esteem. In 1965, the Self-Esteem Scale (SES) was initially designed to assess adolescents' overall feelings of self-worth and self-acceptance by Rosenberg. The SES contains five positive and five negative items, which is a widely used and well validated measurement with good psychometric properties.
Measured: week 0, week 12, week 36
the change from baseline in the Social Support Rating Scale (SSRS)
These changes will reveal the efficacy of acupuncture in the aspect of external social support.The Social Support Rating Scale (SSRS) is a questionnaire with 10 items which consists of objective support (3 items), subjective support (4 items) and the utilization of social support (3 items), which assist to evaluate the characteristics of social support and its association with mental health level, mental illness and various physical diseases. The higher score, the more social support.
Measured: week 0, week 12, week 36
the change from baseline in the Quality of Life（QoL)
These changes will reveal the efficacy of acupuncture in the aspect of subjective life quality feeling. In patients with prostatic diseases, this score is mainly used to evaluate the impact of urination symptoms on quality of life, ranging from very good to very painful, with 0-6 points, to understand the subjective feelings of patients on the level of lower urinary tract symptoms, mainly concerned with the degree of distress caused by lower urinary tract symptoms and whether they can tolerate them. This score is always used within IPSS.
Measured: week 0, week 12, week 36
the change from baseline in NIH-CPSI
These changes will reveal the efficacy of acupuncture in the aspect of symptoms of CP/CPPS.
Measured: week 0, week 12, week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jan 202231 Dec 2023

First posted12 Oct 2021
Study start5 Jan 2022
Primary completion12 Sep 2023 (estimated)
Study completion31 Dec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Chronic Prostatitis With Chronic Pelvic Pain SyndromeStudies 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
Model description: The eligible participants will receive either acupuncture or sham acupuncture randomly assigned at the ratio of 1:1 after signing the Informed consent. Before they accept the treatment, they are acquired to finish the clinical scales and get the fMRI scan. Sanyinjiao (SP6), Zhibian (BL54), Shenshu (BL23), and Huiyang (BL35) have been chosen as acupoints. In the group of both acupuncture and sham acupuncture, the course of treatment is 2 times a week in three months (totally 24 times). There are 3 clinic visits and 3 telephone contacts for emergency. At the ending of the treatment, all the volunteers will be asked to finish the clinical scales and get the fMRI scan again. As the step of following up, all the patients will be asked to finish the clinical scales and get the fMRI scan again to evaluate the efficacy of avoiding the recurrence of acupuncture.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 500 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05075551
Sponsor's protocol ID: 681328
Status last verified: Jan 2023
First submitted: 19 Sep 2021
Last updated: 28 Feb 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Chen J, Zhang H, Niu D, Li H, Wei K, Zhang L, Yin S, Liu L, Zhang X, Zhang M, Liang C. The risk factors related to the severity of pain in patients with Chronic Prostatitis/Chronic Pelvic Pain Syndrome. BMC Urol. 2020 Oct 7;20(1):154. doi: 10.1186/s12894-020-00729-9.
PubMed 33028277
Krieger JN, Nyberg L Jr, Nickel JC. NIH consensus definition and classification of prostatitis. JAMA. 1999 Jul 21;282(3):236-7. doi: 10.1001/jama.282.3.236. No abstract available.
PubMed 10422990
Zhong YM, Luo XC, Chen Y, Lai DL, Lu WT, Shang YN, Zhang LL, Zhou HY. Acupuncture versus sham acupuncture for simple obesity: a systematic review and meta-analysis. Postgrad Med J. 2020 Apr;96(1134):221-227. doi: 10.1136/postgradmedj-2019-137221. Epub 2020 Feb 3.
PubMed 32015189
Hopton A, MacPherson H. Acupuncture for chronic pain: is acupuncture more than an effective placebo? A systematic review of pooled data from meta-analyses. Pain Pract. 2010 Mar-Apr;10(2):94-102. doi: 10.1111/j.1533-2500.2009.00337.x. Epub 2010 Jan 8.
PubMed 20070551
Passavanti MB, Pota V, Sansone P, Aurilio C, De Nardis L, Pace MC. Chronic Pelvic Pain: Assessment, Evaluation, and Objectivation. Pain Res Treat. 2017;2017:9472925. doi: 10.1155/2017/9472925. Epub 2017 Nov 20.
PubMed 29359045
Bhatt RR, Gupta A, Mayer EA, Zeltzer LK. Chronic pain in children: structural and resting-state functional brain imaging within a developmental perspective. Pediatr Res. 2020 Dec;88(6):840-849. doi: 10.1038/s41390-019-0689-9. Epub 2019 Dec 2.
PubMed 31791045
Ge S, Hu Q, Guo Y, Xu K, Xia G, Sun C. Potential Alterations of Functional Connectivity Analysis in the Patients with Chronic Prostatitis/Chronic Pelvic Pain Syndrome. Neural Plast. 2021 May 7;2021:6690414. doi: 10.1155/2021/6690414. eCollection 2021.
PubMed 34035803
Park JJ. Developing and validating a sham acupuncture needle. Acupunct Med. 2009 Sep;27(3):93. doi: 10.1136/aim.2009.001495. No abstract available.
PubMed 19734377

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Chronic Prostatitis With Chronic Pelvic Pain Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Analyzing the Brain Alterations of Acupuncture on Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome Evaluated by fMRI: Study Protocol for a Randomized Trial
ClinicalTrials.gov ID: NCT05075551
Acronym / sponsor ID: 681328
Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Keywords: Chronic Prostatitis/Chronic Pelvic Pain Syndrome, Functional Magnetic Resonance Imaging, Acupuncture
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 500 participants (estimated)
Lead sponsor: Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
Collaborators: Huashan Hospital
Study start: 5 Jan 2022 (actual)
Primary completion: 12 Sep 2023 (estimated)
Study completion: 31 Dec 2023 (estimated)
First posted: 12 Oct 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: The eligible participants will receive either acupuncture or sham acupuncture randomly assigned at the ratio of 1:1 after signing the Informed consent. Before they accept the treatment, they are acquired to finish the clinical scales and get the fMRI scan. Sanyinjiao (SP6), Zhibian (BL54), Shenshu (BL23), and Huiyang (BL35) have been chosen as acupoints. In the group of both acupuncture and sham acupuncture, the course of treatment is 2 times a week in three months (totally 24 times). There are 3 clinic visits and 3 telephone contacts for emergency. At the ending of the treatment, all the volunteers will be asked to finish the clinical scales and get the fMRI scan again. As the step of following up, all the patients will be asked to finish the clinical scales and get the fMRI scan again to evaluate the efficacy of avoiding the recurrence of acupuncture.

Arm	Type	Receives
Acupuncture	Experimental	Device: Acupuncture, Other: fMRI scanBefore participants accept the treatment, they are acquired to finish the clinical scales (including NIH-CPSI scale, HADS, VAS, SSRS, SES, IPSS and QoL) and then get the fMRI scan. Hwato brand disposable acupuncture needles will be used. Sanyinjiao (SP6), Zhibian (BL54), Shenshu (BL23), and Huiyang (BL35) are selected as acupoints. The course of treatment is 2 times a week in three months (totally 24 times). At the ending of the treatment, all the volunteers will be asked to finish the clinical scales and get the fMRI scan again. As the step of following up, all the patients will be asked to finish the clinical scales and get the fMRI scan again to evaluate the efficacy of avoiding the recurrence of acupuncture.
Sham Acupuncture	Sham comparator	Device: Sham acupuncture, Other: fMRI scanIn the sham acupuncture group, these volunteers will receive relatively shallow needling at bilateral sham SP6, BL54, BL23, and BL35. This treatment gets involved in the same duration and frequency of sessions, but the treatment was delivered superficially at non-acupuncture points 10 mm to the lateral of corresponding acupuncture and not above a meridian line (10mm to SP6, BL54, BL23 and BL35). The Hwato brand disposable acupuncture needles will be inserted with a depth of 2-3 mm without any manipulation.The procedure of finishing scales and get fMRI scanning will be the same as the group of acupuncture.

Who may qualify

Ages: 20 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

(1)The clinical diagnosis of CP/CPPS is exclusionary diagnosis.The main steps of diagnosing CP/CPPS are follwing: T
he chief complaint is long-term recurrent pain or discomfort of lumbosacral and perianal distension in the lower abdomen of the external perineum genital area and the superior pubic area (more than 3 months).
Bacterial prostatitis will be eliminated by routine culture of prostatic fluid and urine culture before and after prostatic massage.
Urinary tract infection will be ruled out by routine urinalysis and sediment examination.
(2)Total score of NIH-CPSI ≥ 15.

Key exclusion criteria (3 listed)

The participants would be excluded if they got any acute or chronic infectious disease, other chronic pain diseases, internal organic diseases, history of malignant tumors, and chronic diseases that might contribute to peripheral nerve injury like diabetes mellitus and hypertension.
Prostate changes will be observed by prostate ultrasound and other urogenital and pelvic space-occupying lesions will be excluded.
Contraindications of fMRI scan like claustrophobia and denture implantation status are also considered.

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
AcupunctureHwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used.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; BL23 is in the sacral region, in the second posterior sacral foramen; BL54 is in the fourth posterior sacral foramen, 3 cun beside the median sacral crest; BL35 is in the buttock region, 0.5 cun lateral to the extremity of the coccyx.	Device	Acupuncture
Sham acupunctureHwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used.These volunteers will receive relatively shallow needling at bilateral sham SP6, BL54, BL23 and BL35. This treatment gets involved in the same duration and frequency of sessions, but the treatment was delivered superficially at non-acupuncture points 10 mm to the lateral of corresponding acupuncture and not above a meridian line (10mm to SP6, BL54, BL23 and BL35).The same equipment of fMRI scanner will be used.	Device	Sham Acupuncture
fMRI scanBoth two group will get fMRI scan week 0 (before treatment), week 12 (after treatment) and week 36 (following up). The resting-state fMRI data will be obtained by using a 3.0T GE MR 750 MRI scanner with an eight-channel phase array head coil at the Huashan Hospital, Shanghai. The high resolution T1-weighted magnetic resonance images will be collected by a three-dimensional fast spoiled gradient-echo dual-echo sequence [repetition time (TR) = 8100 ms; echo time (TE) = 3.1 ms; FA = 8 deg; matrix=256 × 256; field of view (FOV)=25.6× 25.6 cm2; slice thickness=1 mm; no gap and 156 slices]. The whole resting state fMRI data will be acquired by using a gradient-recalled echo-planar imaging pulse sequence (TR/TE = 2,000/30 ms; FA = 90°; acquisition matrix = 64×64; FOV = 22×22 cm2; slice thickness= 4 mm; 43 slices and total 240 time points; no gap).	Other	Acupuncture, Sham Acupuncture

Primary outcome

The change in the NIH-CPSI total score at the end of week 12 and week 36
Time frame: week 0, week 12 and week 36
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) , compared with the baseline in week 0.It is because a decline of at least 6 points in NIH-CPSI is acknowledged as the minimal clinically important difference. The NIH-CPSI is a self-assessment form with nine items, which the main components encompass pain with 4 items focused on location, severity and frequency, urinary function embracing one irritative item and one obstructive item, and quality of life impact with 3 items about the effect of symptoms on daily activities. The NIH-CPSI provides a systematized and unanimously accepted outcome measuring tool, and it is widely used in clinical trials, along with in the evidence-based evaluation of treatment effects.

9 secondary outcomes

The alterations in brain of patients with CP/CPPS measured by fMRI when finishing the whole treatment
Time frame: week 12
The alterations in brain of patients with CP/CPPS measured by fMRI in the following-up (24weeks after treatment)
Time frame: week 36
the change from baseline in NIH-CPSI subscales
Time frame: week 0, week 12, week 36
the change from baseline in the International Prostate Symptom Score (IPSS)
Time frame: week 0, week 12, week 36
the change from baseline in the Visual Analogue Scale (VAS)
Time frame: week 0, week 12, week 36
the change from baseline in the Self-Esteem Scale (SES).
Time frame: week 0, week 12, week 36
the change from baseline in the Social Support Rating Scale (SSRS)
Time frame: week 0, week 12, week 36
the change from baseline in the Quality of Life（QoL)
Time frame: week 0, week 12, week 36
the change from baseline in NIH-CPSI
Time frame: week 0, week 12, week 36

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
Background: PubMed 33028277Chen J, Zhang H, Niu D, Li H, Wei K, Zhang L, Yin S, Liu L, Zhang X, Zhang M, Liang C. The risk factors related to the severity of pain in patients with Chronic Prostatitis/Chronic Pelvic Pain Syndrome. BMC Urol. 2020 Oct 7;20(1):154. doi: 10.1186/s12894-020-00729-9.
Background: PubMed 10422990Krieger JN, Nyberg L Jr, Nickel JC. NIH consensus definition and classification of prostatitis. JAMA. 1999 Jul 21;282(3):236-7. doi: 10.1001/jama.282.3.236. No abstract available.
Background: PubMed 32015189Zhong YM, Luo XC, Chen Y, Lai DL, Lu WT, Shang YN, Zhang LL, Zhou HY. Acupuncture versus sham acupuncture for simple obesity: a systematic review and meta-analysis. Postgrad Med J. 2020 Apr;96(1134):221-227. doi: 10.1136/postgradmedj-2019-137221. Epub 2020 Feb 3.
Background: PubMed 20070551Hopton A, MacPherson H. Acupuncture for chronic pain: is acupuncture more than an effective placebo? A systematic review of pooled data from meta-analyses. Pain Pract. 2010 Mar-Apr;10(2):94-102. doi: 10.1111/j.1533-2500.2009.00337.x. Epub 2010 Jan 8.
Background: PubMed 29359045Passavanti MB, Pota V, Sansone P, Aurilio C, De Nardis L, Pace MC. Chronic Pelvic Pain: Assessment, Evaluation, and Objectivation. Pain Res Treat. 2017;2017:9472925. doi: 10.1155/2017/9472925. Epub 2017 Nov 20.
Background: PubMed 31791045Bhatt RR, Gupta A, Mayer EA, Zeltzer LK. Chronic pain in children: structural and resting-state functional brain imaging within a developmental perspective. Pediatr Res. 2020 Dec;88(6):840-849. doi: 10.1038/s41390-019-0689-9. Epub 2019 Dec 2.
Background: PubMed 34035803Ge S, Hu Q, Guo Y, Xu K, Xia G, Sun C. Potential Alterations of Functional Connectivity Analysis in the Patients with Chronic Prostatitis/Chronic Pelvic Pain Syndrome. Neural Plast. 2021 May 7;2021:6690414. doi: 10.1155/2021/6690414. eCollection 2021.
Background: PubMed 19734377Park JJ. Developing and validating a sham acupuncture needle. Acupunct Med. 2009 Sep;27(3):93. doi: 10.1136/aim.2009.001495. No abstract available.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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 and fMRI scan in people with Chronic Prostatitis With Chronic Pelvic Pain Syndrome, run by Shanghai University of Traditional Chinese Medicine 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 5 inclusion and 3 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 28 Feb 2023. 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?

Results are not available in the source record.

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?

The change in the NIH-CPSI total score at the end of week 12 and week 36 (time frame: week 0, week 12 and week 36). 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 NCT05075551, which also lists 8 linked publications.

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 28 Feb 2023.