Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2023

Open Access 01-12-2023 | Shockwave Therapy | Study protocol

Comparing the effectiveness of extracorporeal shockwave therapy and myofascial release therapy in chronic pelvic pain syndrome: study protocol for a randomized controlled trial

Authors: Ningqing Huang, Zhi Qin, Wudong Sun, Kaiming Bao, Jingxian Zha, Peng Zhang, Panpan Feng, Xiaojun Zhao, Mengqian Liu, Jinjun Shi, Ming Ma

Published in: Trials | Issue 1/2023

Login to get access

Abstract

Background

Chronic prostatitis/chronic pelvic pain syndrome is a highly prevalent syndrome. Previous studies showed that extracorporeal shockwave therapy and myofascial release therapy could improve the quality of life in patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Theoretically, combined therapy with extracorporeal shockwave therapy and myofascial release therapy will likely have significant advantages in treating CP/CPPS. We, therefore, present a protocol for conducting a well-designed randomized controlled trial to compare the efficacy and safety of each therapy.

Methods

The proposed study will be a three-group randomized control trial (RCT) design that includes 150 participants from Zhongda Hospital Affiliated to Southeast University, with equal allocation of participants to the three intervention groups. The study duration will be 8 weeks, which includes a 4-week treatment period and a 4-week follow-up period. The primary outcome will be the changes in surface electromyography (sEMG) assessment and National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI). The secondary outcomes will include the changes in three-dimensional quantification, shear wave elastography (SWE), and sympathetic skin response (SSR) testing. Assessments will be conducted before the intervention (T0), before the 5th intervention (T1), immediately after the 8th intervention (T2), and the 4th week after the end of the 8th intervention (T3).

Discussion

This trial will compare the differences in efficacy between single extracorporeal shockwave therapy, single myofascial release therapy, and combined therapy to select the most appropriate treatment option for patients with CP/CPPS. The possible pathogenesis of CP/CPPS would also be analyzed by comparing the intercorrelation between each objective and subjective measurement (NIH-CPSI score, sEMG, SWE, SSR).

Trial registration

The name of the registry: Extracorporeal Shockwave and Myofascial Release Therapy in Chronic Pelvic Pain Syndrome.
Registration number: NCT05659199. Date of registration: December 2022.
Appendix
Available only for authorised users
Literature
1.
Anderson RU, Wise D, Nathanson BH. Chronic prostatitis and/or chronic pelvic pain as a psychoneuromuscular disorder-a meta-analysis. Urology. 2018;120:23–9.PubMed
2.
Murphy AB, Macejko A, Taylor A, et al. Chronic prostatitis: management strategies [J]. Drugs. 2009;69(1):71–84.PubMed
3.
Kwon JK, Chang IH. Pain, catastrophizing, and depression in chronic prostatitis/chronic pelvic pain syndrome [J]. Int Neurourol J. 2013;17(2):48–58.PubMedPubMedCentral
4.
吴春磊. 中国人群中慢性盆腔疼痛症状与前列腺炎症的关系的流行病学研究[D]; 广西医科大学, 2014.
5.
6.
Barone B, De Luca L, Napolitano L, et al. Lower urinary tract symptoms and mental health during COVID-19 pandemic. Archivio italiano di urologia, andrologia : organo ufficiale [di] Societa italiana di ecografia urologica e nefrologica. 2022;94(1):46–50.
7.
Magistro G, Stief CG, Wagenlehner FME. Chronic prostatitis/chronic pelvic pain syndrome] [J. Der Urologe Ausg A. 2020;59(6):739–48.PubMed
8.
Forrest JB, Schmidt S. Interstitial cystitis, chronic nonbacterial prostatitis and chronic pelvic pain syndrome in men: a common and frequently identical clinical entity. J Urol. 2004;172(6 Pt 2):2561–2.PubMed
9.
Shoskes DA, Landis JR, Wang Y, et al. Impact of post-ejaculatory pain in men with category III chronic prostatitis/chronic pelvic pain syndrome. J Urol. 2004;172(2):542–7.PubMed
10.
Shoskes DA, Berger R, Elmi A, et al. Muscle tenderness in men with chronic prostatitis/chronic pelvic pain syndrome: the chronic prostatitis cohort study. J Urol. 2008;179(2):556–60.PubMed
11.
Chen X, Zhou Z, Qiu X, et al. The effect of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) on erectile function: a systematic review and meta-analysis. PLoS One. 2015;10(10):e0141447.PubMedPubMedCentral
12.
Rees J, Abrahams M, Doble A, et al. Diagnosis and treatment of chronic bacterial prostatitis and chronic prostatitis/chronic pelvic pain syndrome: a consensus guideline. BJU Int. 2015;116(4):509–25.PubMedPubMedCentral
13.
Xu Y, Zhang L, Shen Y, et al. Effectiveness of psychological interventions for treating chronic prostatitis/chronic pelvic pain syndrome: a protocol for systematic review and meta-analysis. Medicine. 2020;99(39):e22151.PubMedPubMedCentral
14.
15.
Seng JS, Graham-Bermann SA, Clark MK, et al. Posttraumatic stress disorder and physical comorbidity among female children and adolescents: results from service-use datas. Pediatrics. 2005;116(6):e767–76.PubMed
16.
Piontek K, Ketels G, Klotz SGR, et al. The longitudinal association of symptom-related and psychological factors with health-related quality of life in patients with chronic pelvic pain syndrome. J Psychosom Res. 2022;153:110707.PubMed
17.
18.
Rabal Conesa C, Cao Avellaneda E, López Cubillana P, et al. Manual therapy intervention in men with chronic pelvic pain syndrome or chronic prostatitis: an exploratory prospective case-series. Cureus. 2022;14(4):e24481.PubMedPubMedCentral
19.
Bian Z, Jin C, Mo F, et al. Dietary habits and lifestyle related to the effectiveness of low-intensity extracorporeal shock wave therapy for chronic prostatitis/chronic pelvic pain syndrome-like symptoms: Initial results. Andrologia. 2022;54(9):e14490.PubMed
20.
Jin C, Zhang S, Mo F, et al. Efficacy and safety evaluation of low-intensity extracorporeal shock wave therapy on prostatitis-like symptoms: an open-label, single-arm trial. Andrologia. 2022;54(1):e14260.PubMed
21.
Sakr AM, Fawzi AM, Kamel M, et al. Outcomes and clinical predictors of extracorporeal shock wave therapy in the treatment of chronic prostatitis/chronic pelvic pain syndrome: a prospective randomized double-blind placebo-controlled clinical trial. Prostate Cancer Prostatic Dis. 2022;25(1):93–9.PubMed
22.
Wang HJ, Su CH, Chen YM, Yu CC, Chuang YC. Molecular Effects of Low-Intensity Shock Wave Therapy on L6 Dorsal Root Ganglion/Spinal Cord and Blood Oxygenation Level-Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Changes in Capsaicin-Induced Prostatitis Rat Models. Int J Mol Sci. 2022;23(9):4716. https://​doi.​org/​10.​3390/​ijms23094716.
23.
24.
Emara HA, Al-Johani AH, Khaled OA, et al. Effect of extracorporeal shock wave therapy on spastic equinus foot in children with unilateral cerebral palsy. J Taibah Univ Med Sci. 2022;17(5):794–804.PubMedPubMedCentral
25.
Xiao L, Liu C, Li Y, et al. Effects of whole body vibration combined with extracorporeal shock wave therapy on spasticity and balance gait parameters in hemiplegic patients with stroke. Zhong nan da xue xue bao Yi xue ban = J Cent South Univ Med Sci. 2022;47(6):755–61.
26.
Pierce KE, Krol O, Kummer N, et al. Increased cautiousness in adolescent idiopathic scoliosis patients concordant with syringomyelia fails to improve overall patient outcomes. J Craniovertebral Junction Spine. 2021;12(2):197–201.
27.
Pankowski R, Roclawski M, Dziegiel K, et al. Transient monoplegia as a result of unilateral femoral artery ischemia detected by multimodal intraoperative neuromonitoring in posterior scoliosis surgery: a case report. Medicine. 2016;95(6):e2748.PubMedPubMedCentral
28.
Cho DS, Choi JB, Kim YS, et al. Heart rate variability in assessment of autonomic dysfunction in patients with chronic prostatitis/chronic pelvic pain syndrome. Urology. 2011;78(6):1369–72.PubMed
29.
Krieger JN, Nyberg JR L, Nickel JC. NIH consensus definition and classification of prostatitis. Jama. 1999;282(3):236.PubMed
30.
Inci E, Turkay R, Nalbant MO, et al. The value of shear wave elastography in the quantification of corpus cavernosum penis rigidity and its alteration with age. Eur J Radiol. 2017;89:106–10.PubMed
31.
Vetrugno R, Liguori R, Cortelli P, et al. Sympathetic skin response: basic mechanisms and clinical applications. Clin Auton Res. 2003;13(4):256–70.PubMed
32.
Fitzgerald MP, Anderson RU, Potts J, et al. Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes. J Urol. 2013;189(1 Suppl):S75-85.PubMedPubMedCentral
33.
Morozov A, Bazarkin A, Babaevskaya D, et al. A systematic review and meta-analysis of placebo effect in clinical trials on chronic prostatitis/chronic pelvic pain syndrome. Prostate. 2022;82(6):633–56.PubMed
34.
Qin Z, Zhang C, Guo J, et al. Oral pharmacological treatments for chronic prostatitis/chronic pelvic pain syndrome: a systematic review and network meta-analysis of randomised controlled trials. EClinicalMedicine. 2022;48:101457.PubMedPubMedCentral
35.
Breser ML, Salazar FC, Rivero VE, et al. Immunological mechanisms underlying chronic pelvic pain and prostate inflammation in chronic pelvic pain syndrome. Front Immunol. 2017;8:898.PubMedPubMedCentral
36.
Zimmermann R, Cumpanas A, Hoeltl L, et al. Extracorporeal shock-wave therapy for treating chronic pelvic pain syndrome: a feasibility study and the first clinical results. BJU Int. 2008;102(8):976–80.PubMed
37.
Pundik S, Mccabe J, Skelly M, et al. Association of spasticity and motor dysfunction in chronic stroke. Ann Phys Rehabil Med. 2019;62(6):397–402.PubMed
38.
Puce L, Bragazzi NL, Currà A, et al. Not all forms of muscle hypertonia worsen with fatigue: a pilot study in para swimmers. Front Physiol. 2022;13:902663.PubMedPubMedCentral
39.
Sheean G, Mcguire JR. Spastic hypertonia and movement disorders: pathophysiology, clinical presentation, and quantification. PM R. 2009;1(9):827–33.PubMed
40.
Murphy SF, Schaeffer AJ, Thumbikat P. Immune mediators of chronic pelvic pain syndrome. Nat Rev Urol. 2014;11(5):259–69.PubMedPubMedCentral
41.
Chung SD, Lin HC. Association between chronic prostatitis/chronic pelvic pain syndrome and anxiety disorder: a population-based study. PLoS One. 2013;8(5):e64630.PubMedPubMedCentral
42.
Zhao M, Gao QH, Liu SJ, et al. Quality assessment and relevant clinical impact of randomized controlled trials on chronic prostatitis/chronic pelvic pain syndrome. BMC Urol. 2022;22(1):122.PubMedPubMedCentral
43.
Van Reijn-Baggen DA, Han-Geurts IJM, Voorham-van der Zalm PJ, et al. Pelvic floor physical therapy for pelvic floor hypertonicity: a systematic review of treatment efficacy. Sex Med Rev. 2022;10(2):209–30.PubMed
44.
Anderson RU, Wise D, Sawyer T, et al. 6-day intensive treatment protocol for refractory chronic prostatitis/chronic pelvic pain syndrome using myofascial release and paradoxical relaxation training. J Urol. 2011;185(4):1294–9.PubMed
45.
Anderson RU, Wise D, Sawyer T, et al. Equal improvement in men and women in the treatment of urologic chronic pelvic pain syndrome using a multi-modal protocol with an internal myofascial trigger point wand. Appl Psychophysiol Biofeedback. 2016;41(2):215–24.PubMed
46.
Al Edwan GM, Muheilan MM, Atta ON. Long term efficacy of extracorporeal shock wave therapy [ESWT] for treatment of refractory chronic abacterial prostatitis. Ann Med Surg (2012). 2017;14:12–7.
47.
Kang Y, Song P, Cao D, et al. The efficacy and safety of extracorporeal shockwave therapy versus acupuncture in the management of chronic prostatitis/chronic pelvic pain syndrome: evidence based on a network meta-analysis. Am J Mens Health. 2021;15(6):15579883211057998.PubMedPubMedCentral
48.
Kwon DR, Kwon DG. Botulinum Toxin a Injection Combined with Radial Extracorporeal Shock Wave Therapy in Children with Spastic Cerebral Palsy: Shear Wave Sonoelastographic Findings in the Medial Gastrocnemius Muscle, Preliminary Study. Children (Basel). 2021;8(11):1059. https://​doi.​org/​10.​3390/​children8111059.
49.
Park GY, Kwon DR. Sonoelastographic evaluation of medial gastrocnemius muscles intrinsic stiffness after rehabilitation therapy with botulinum toxin a injection in spastic cerebral palsy. Arch Phys Med Rehabil. 2012;93(11):2085–9.PubMed
50.
Doytchinova A, Hassel JL, Yuan Y, et al. Simultaneous noninvasive recording of skin sympathetic nerve activity and electrocardiogram. Heart Rhythm. 2017;14(1):25–33.PubMed
Metadata
Title
Comparing the effectiveness of extracorporeal shockwave therapy and myofascial release therapy in chronic pelvic pain syndrome: study protocol for a randomized controlled trial
Authors
Ningqing Huang
Zhi Qin
Wudong Sun
Kaiming Bao
Jingxian Zha
Peng Zhang
Panpan Feng
Xiaojun Zhao
Mengqian Liu
Jinjun Shi
Ming Ma
Publication date
01-12-2023
Publisher
BioMed Central
Published in
Trials / Issue 1/2023
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-023-07633-1

Other articles of this Issue 1/2023

Trials 1/2023 Go to the issue

Study protocol

Efficacy of an Internet-based intervention with self-applied exposure therapy in virtual reality for people with panic disorder: study protocol for a randomized controlled trial

Research

Safety of AFM11 in the treatment of patients with B-cell malignancies: findings from two phase 1 studies

Correction

Correction: Testing the combination of Feeling Safe and peer counselling against formulation-based cognitive behaviour therapy to promote psychological wellbeing in people with persecutory delusions: study protocol for a randomized controlled trial (the Feeling Safe-NL Trial)

Commentary

Medicines and Healthcare products Regulatory Agency’s “Consultation on proposals for legislative changes for clinical trials”: a response from the Trials Methodology Research Partnership Adaptive Designs Working Group, with a focus on data sharing

Review

Clinical research for life-threatening illnesses requiring emergency hospitalisation: a critical interpretive synthesis of qualitative data related to the experience of participants and their caregivers

Study protocol

The (cost) effectiveness of a very low-energy diet intervention with the use of eHealth in patients with type 2 diabetes and obesity: study protocol for a randomised controlled non-inferiority trial (E-diet trial)