Extracorporeal Shockwave and Myofascial Release Therapy in Chronic Pelvic Pain Syndrome

Chronic Pelvic Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05659199
• Other study ID #: ZongdaH
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2022
• Source: Zongda Hospital affiliated to Southeast University
• Contact: Ningqing Huang
• Phone: 18852068261
• Email: hnq1998118[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• ? 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; ? Patients sign the informed consent form.

Exclusion Criteria:

• ? 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; ? 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; ? Patients with contraindications to physiotherapy; ? BMI>22.9

Related Conditions & MeSH terms

• Chronic Pelvic Pain Syndrome
• Pelvic Pain
• Somatoform Disorders
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
China	Zhongda Hospital affiliated to Southeast University	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Zongda Hospital affiliated to Southeast University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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
Secondary	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