Clinical trial NCT05075551: Analyzing the Brain Alterations of Acupuncture on Patients With CP/CPPS Evaluated by fMRI
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Keywords: Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Functional Magnetic Resonance Imaging
Acupuncture
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Huashan Hospital
First posted: 2021-10-12
Enrollment: 500
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

(1)The clinical diagnosis of CP/CPPS is exclusionary diagnosis.The main steps of diagnosing CP/CPPS are follwing: T

1. 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).
2. Bacterial prostatitis will be eliminated by routine culture of prostatic fluid and urine culture before and after prostatic massage.
3. Urinary tract infection will be ruled out by routine urinalysis and sediment examination.

(2)Total score of NIH-CPSI ≥ 15.

Exclusion Criteria:

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.

Primary outcomes:
measure: The change in the NIH-CPSI total score at the end of week 12 and week 36
timeFrame: week 0, week 12 and week 36
Secondary outcomes:
measure: The alterations in brain of patients with CP/CPPS measured by fMRI when finishing the whole treatment
timeFrame: week 12
measure: The alterations in brain of patients with CP/CPPS measured by fMRI in the following-up (24weeks after treatment)
timeFrame: week 36
measure: the change from baseline in NIH-CPSI subscales
timeFrame: week 0, week 12, week 36
measure: the change from baseline in the International Prostate Symptom Score (IPSS)
timeFrame: week 0, week 12, week 36
measure: the change from baseline in the Visual Analogue Scale (VAS)
timeFrame: week 0, week 12, week 36
measure: the change from baseline in the Self-Esteem Scale (SES).
timeFrame: week 0, week 12, week 36
measure: the change from baseline in the Social Support Rating Scale (SSRS)
timeFrame: week 0, week 12, week 36
measure: the change from baseline in the Quality of Life（QoL)
timeFrame: week 0, week 12, week 36
measure: the change from baseline in NIH-CPSI
timeFrame: week 0, week 12, week 36
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Acupuncture, LongHua Hospital, Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.