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

NCT ID: NCT05075551

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-05
• Study Completion Date: 2023-12-31

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.

Conditions

Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Acupuncture

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.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: DEVICE

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.

fMRI scan

Intervention Type: OTHER

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).

Sham Acupuncture

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.

Group Type: SHAM_COMPARATOR

Sham acupuncture

Intervention Type: DEVICE

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 scan

Intervention Type: OTHER

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).

Interventions

Acupuncture

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.

Intervention Type: DEVICE

Sham acupuncture

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.

Intervention Type: DEVICE

fMRI scan

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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Huashan Hospital

OTHER

Sponsor Role: collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 19734377 (View on PubMed)

Other Identifiers

681328

Identifier Type: -

Identifier Source: org_study_id