Extracorporeal Shockwave and Myofascial Release Therapy in Chronic Pelvic Pain Syndrome

Zongda Hospital affiliated to Southeast University

Status: Not yet enrolling

Conditions: Chronic Pelvic Pain Syndrome

Treatments: Device: extracorporeal shockwave; Behavioral: myofascial release

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05659199

ZongdaH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups

extracorporeal shockwave therapy

Experimental group

Description:

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.

Treatment:

Device: extracorporeal shockwave

myofascial release therapy

Experimental group

Description:

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.

Treatment:

Behavioral: myofascial release

extracorporeal shockwave combined with myofascial release therapy

Experimental group

Description:

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

Treatment:

Behavioral: myofascial release

Device: extracorporeal shockwave