Extracorporeal Shockwave and Myofascial Release Therapy in Chronic Pelvic Pain Syndrome

NCT ID: NCT05659199

Last Updated: 2023-01-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-06-30

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.

Conditions

Chronic Pelvic Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

extracorporeal shockwave

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

myofascial release

Intervention Type: BEHAVIORAL

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.

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

Group Type: EXPERIMENTAL

extracorporeal shockwave

Intervention Type: DEVICE

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.

myofascial release

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Zongda Hospital affiliated to Southeast University

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ming Ma, Doctor

Role: STUDY_DIRECTOR

Zhongda Hospital

Locations

Zhongda Hospital affiliated to Southeast University

Nanjing, , China

Countries

China

Central Contacts

Ningqing Huang

Role: CONTACT

hnq1998118@163.com

18852068261

Ningqing Huang

Role: CONTACT

huangningqing@seu.edu.cn

18852068261

Facility Contacts

Ningqing Huang, master

Role: primary

hnq1998118@163.com

18852068261

References

Huang N, Qin Z, Sun W, Bao K, Zha J, Zhang P, Feng P, Zhao X, Liu M, Shi J, Ma M. Comparing the effectiveness of extracorporeal shockwave therapy and myofascial release therapy in chronic pelvic pain syndrome: study protocol for a randomized controlled trial. Trials. 2023 Oct 18;24(1):675. doi: 10.1186/s13063-023-07633-1.

Reference Type: DERIVED

PMID: 37853420 (View on PubMed)

Other Identifiers

ZongdaH

Identifier Type: -

Identifier Source: org_study_id