Extracorporeal Shockwave and Myofascial Release Therapy in Chronic Pelvic Pain Syndrome

NCT05659199 | Unknown

• 1 other identifier: ZongdaH
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pelvic Pain Syndrome

Keywords

chronic pelvic pain syndrome; extracorporeal shockwave; myofascial release therapy; surface electromyography; sympathetic skin response

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Three-dimensional quantification and Shear Wave Elastography (SWE) changes

  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

  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

Study Arms (3)

extracorporeal shockwave therapy

EXPERIMENTAL

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

myofascial release therapy

EXPERIMENTAL

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

extracorporeal shockwave combined with myofascial release therapy

EXPERIMENTAL

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; Behavioral: myofascial release

Interventions

extracorporeal shockwave 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.

extracorporeal shockwave combined with myofascial release therapy; extracorporeal shockwave therapy

myofascial release 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; myofascial release therapy

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: There is no need to confirm the self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zongda Hospital affiliated to Southeast University: lead

Study Sites (1)

Zhongda Hospital affiliated to Southeast University

Nanjing, China

Location

Related Publications (1)

• 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.

  PMID: 37853420 DERIVED

MeSH Terms

Interventions

Myofascial Release Therapy

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Ming Ma, Doctor

  Zhongda Hospital

  STUDY DIRECTOR

Central Study Contacts

Ningqing Huang

CONTACT

18852068261; hnq1998118@163.com

Ningqing Huang

CONTACT

18852068261; huangningqing@seu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: fascia trigger point release group extracorporeal shock wave group extracorporeal shock wave and fascial trigger point release treatment group

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 21, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: January 3, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• Access Criteria: All relevant data from this study will be made available upon study completion.

Locations

CN (1)