Extracorporeal Shockwave and Myofascial Release Therapy in Chronic Pelvic Pain Syndrome

Study on the Intervention of Extracorporeal Shockwave Therapy and Myofascial Release Therapy in Chronic Pelvic Pain Syndrome

The primary aims of this research are three folds: (1) To identify more relatively effective interventions for improving pain symptoms in CP/CPPS patients. (2) To ascertain the correlation between PFM elastic modulus and tenderness symptoms. This may find a more objective method of assessing efficacy. (3) To determine the correlation between the intensity of the sympathetic response and the patient's symptoms and to explore other possible pathogenetic mechanisms.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pelvic Pain Syndrome
• Intervention / Treatment: Device: extracorporeal shockwave; Behavioral: myofascial release

Detailed Description

Chronic prostatitis/chronic pelvic pain syndrome is a high prevalent syndrome. Previous studies showed that extracorporeal shockwave therapy and myofascial release therapy could improve quality of life in patients with Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Theoretically, a combined therapy with extracorporeal shockwave therapy and myofascial release therapy is likely to have significant advantages in treating CP/CPPS.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ningqing Huang; Phone Number: 18852068261; Email: hnq1998118@163.com
• Study Contact Backup: Name: Ningqing Huang; Phone Number: 18852068261; Email: huangningqing@seu.edu.cn

Study Locations

• China
  • Nanjing, China
    • Zhongda Hospital Affiliated to Southeast University
    • Contact: Ningqing Huang, master; Phone Number: 18852068261; Email: hnq1998118@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• ① According to the National Institutes of Health classification of prostatitis[27], all male patients meet the diagnostic criteria for chronic prostatitis type IIIB/chronic pelvic pain syndrome (pain in the bladder, groin, perineal area, genitalia or lower abdomen with no significant abnormalities on urological examination);

  • Patients are aged 20-40 years;

    • Patients with Chronic pelvic pain lasting over 6 months； ④ Patients sign the informed consent form.

Exclusion Criteria:

• ① Patients with significant coagulation disorders, perineal anatomical abnormalities, hormonal abnormalities and neurological abnormalities;

  • Patients with a clear cause of pelvic pain, such as a history of previous surgery, chronic infection, trauma, prostatitis and epididymitis;

    • Patients receiving other treatments during the study; ④ Patients with any urethral pathology;

      • Patients who have had closed lumbar injections and previous lumbar surgery within six months;

        • Patients with other conditions causing pelvic pain; ⑦ Patients with contraindications to physiotherapy; ⑧ BMI>22.9

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: extracorporeal shockwave therapy; extracorporeal shockwave group: Patients will be treated with extracorporeal shockwave therapy (ESWT) with bladder lithotomy position, twice a week for 4 weeks, 3,000 individually with a maximum total energy flow density of 0.25 mJ/mm2, rate 3Hz each time. Extracorporeal shockwave (RUIDI.SWT001, Shenzhen, China) can provide a kind of physical spark wave energy, that will be delivered by the probe. The water sac probe will be moved slowly over the groin, perineum and crura of the penis.	Device: extracorporeal shockwave; Patients will be treated with extracorporeal shockwave therapy (ESWT) with bladder lithotomy position, twice a week for 4 weeks, 3,000 individually with a maximum total energy flow density of 0.25 mJ/mm2, rate 3Hz each time. Extracorporeal shockwave (RUIDI.SWT001, Shenzhen, China) can provide a kind of physical spark wave energy, that will be delivered by the probe. The water sac probe will be moved slowly over the groin, perineum and crura of the penis.
Experimental: myofascial release therapy; myofascial release group: Based on the palpation findings, pressure was applied at 1 kg/cm2 (within the patient's tolerable range depending on the individual) to the points where patients had a VAS pain score of 4 or more during palpation. Intermittent pressure will be applied for 180-210s at the tenderness until the muscle relaxed.	Behavioral: myofascial release; pressure was applied at 1 kg/cm2 (within the patient's tolerable range depending on the individual) to the points where patients had a VAS pain score of 4 or more during palpation. Intermittent pressure will be applied for 180-210s at the tenderness until the muscle relaxed.
Experimental: extracorporeal shockwave combined with myofascial release therapy; Combined therapy group: On top of the routine palpation, the combined intervention group will be then treated with extracorporeal shockwave and myofascial release therapy in identical format as that in the intervention A and B	Device: extracorporeal shockwave; Patients will be treated with extracorporeal shockwave therapy (ESWT) with bladder lithotomy position, twice a week for 4 weeks, 3,000 individually with a maximum total energy flow density of 0.25 mJ/mm2, rate 3Hz each time. Extracorporeal shockwave (RUIDI.SWT001, Shenzhen, China) can provide a kind of physical spark wave energy, that will be delivered by the probe. The water sac probe will be moved slowly over the groin, perineum and crura of the penis.; Behavioral: myofascial release; pressure was applied at 1 kg/cm2 (within the patient's tolerable range depending on the individual) to the points where patients had a VAS pain score of 4 or more during palpation. Intermittent pressure will be applied for 180-210s at the tenderness until the muscle relaxed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic floor muscle surface electromyography changes	Pelvic floor muscle sEMG values will be collected using the Glazer pelvic floor muscle sEMG assessment (VISHEE SA9800) Pre-resting sEMG; Tense contraction phase sEMG; Endurance contraction phase sEMG; Post-resting EMG.	Assessments will be conducted before the intervention (T0), before the 5th intervention (T1), immediately after the 8th intervention (T2), and at the 4th week after the end of the 8th intervention (T3),assessing changes between these time points.
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) changes	Questionnaire with 13 entries, including 4 aspects: pain and discomfort symptom score, urinary symptom score, symptom impact score, quality of life score, with a total score of 0 to 43. The severity of CP/CPPS can be graded according to the total scores: mild (1-14), moderate (15-29), or severe (30-43). The efficacy evaluation criteria are developed with reference to the National Institutes of Health-Chronic Prostatitis Symptom Index score. Clinical control is defined as ≥ 90% decrease in the NIH-CPSI score; obvious improvement as ≥ 60% and < 89% decrease; improvement as ≥ 30% and < 59% decrease, and ineffective as < 30% decrease.	Assessments will be conducted before the intervention (T0), before the 5th intervention (T1), immediately after the 8th intervention (T2), and at the 4th week after the end of the 8th intervention (T3),assessing changes between these time points

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Three-dimensional quantification and Shear Wave Elastography (SWE) changes	Trans-rectal three-dimensional ultrasound (VOLUSON E8) will be used to assess the morphological parameters of the lacunae of the levator hiatus in CP/CPPS patients, the area of the levator hiatus is situated at a depth of 2-4 cm from the perineum, where is well within the effective range of 7-4-MHz transducers.	Assessments will be conducted before the intervention (T0) and at the 4th week after the end of the 8th intervention (T3),assessing change between two time points
sympathetic skin response (SSR) changes	SSR is a recently established method of non-invasive somatic neurography offers the advantages of both non-invasiveness and specificity, using the SA7550 FlexComp Infiniti System (Thought Technology, Canada). Sympathetic skin responses will be recorded with the active electrodes placed in the left palm and the reference electrodes on the dorsum of the left hand, while the patient will be in the sitting position. A channel recording from hand will be obtained simultaneously by stimulating the contralateral median nerve at the level of the wrist with a stimulation intensity at 20 mA for 0.2 ms[29]. A total of three potentials will be recorded and the mean values will be used for analysis.	Assessments will be conducted before the intervention (T0) and at the 4th week after the end of the 8th intervention (T3),assessing change between two time points

Collaborators and Investigators

• Sponsor: Zongda Hospital affiliated to Southeast University
• Investigators: Study Director: Ming Ma, Doctor, Zhongda Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: December 9, 2022
• First Submitted That Met QC Criteria: December 17, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Estimate): January 2, 2023
• Last Update Submitted That Met QC Criteria: December 30, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: chronic pelvic pain syndrome; surface electromyography; sympathetic skin response; extracorporeal shockwave; myofascial release therapy
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Pain; Neurologic Manifestations; Disease; Syndrome; Somatoform Disorders; Pelvic Pain
• Other Study ID Numbers: ZongdaH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: No datasets were generated or analyzed during the current study. The results will be published in a peer-reviewed journal upon study completion. Datasets generated or analyzed in this study will be provided by the corresponding authors upon reasonable request.
• IPD Sharing Time Frame: The results will be published in a peer-reviewed journal upon study completion. Datasets generated or analyzed in this study will be provided by the corresponding authors upon reasonable request.
• IPD Sharing Access Criteria: All relevant data from this study will be made available upon study completion.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No