Clinical trial NCT05659199: Extracorporeal Shockwave and Myofascial Release Therapy in Chronic Pelvic Pain Syndrome
Official title: Study on the Intervention of Extracorporeal Shockwave Therapy and Myofascial Release Therapy in Chronic Pelvic Pain Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pelvic Pain Syndrome
Keywords: chronic pelvic pain syndrome
extracorporeal shockwave
myofascial release therapy
surface electromyography
sympathetic skin response
Lead sponsor: Zongda Hospital affiliated to Southeast University
Sponsor class: NETWORK
First posted: 2022-12-21
Enrollment: 150
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: fascia trigger point release group extracorporeal shock wave group extracorporeal shock wave and fascial trigger point release treatment group
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pelvic floor muscle surface electromyography changes
timeFrame: 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.
measure: National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) changes
timeFrame: 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 outcomes:
measure: Three-dimensional quantification and Shear Wave Elastography (SWE) changes
timeFrame: 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
measure: sympathetic skin response (SSR) changes
timeFrame: 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
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital affiliated to Southeast University
Study officials:
affiliation: Zhongda Hospital
name: Ming Ma, Doctor
role: STUDY_DIRECTOR
References: