Back to resultsExtracorporeal Shockwave and Myofascial Release Therapy in Chronic Pelvic Pain Syndrome
Primary Purpose
Chronic Pelvic Pain Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
extracorporeal shockwave
myofascial release
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pelvic Pain Syndrome focused on measuring chronic pelvic pain syndrome, extracorporeal shockwave, myofascial release therapy, surface electromyography, sympathetic skin response
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
Sites / Locations
- Zhongda Hospital affiliated to Southeast University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
extracorporeal shockwave therapy
myofascial release therapy
extracorporeal shockwave combined with myofascial release therapy
Arm 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.
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.
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
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05659199
First Posted
December 9, 2022
Last Updated
December 30, 2022
Sponsor
Zongda Hospital affiliated to Southeast University
1. Study Identification
Unique Protocol Identification Number
NCT05659199
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zongda Hospital affiliated to Southeast University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pelvic Pain Syndrome
Keywords
chronic pelvic pain syndrome, extracorporeal shockwave, myofascial release therapy, surface electromyography, sympathetic skin response
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
fascia trigger point release group extracorporeal shock wave group extracorporeal shock wave and fascial trigger point release treatment group
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
extracorporeal shockwave therapy
Arm Type
Experimental
Arm 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.
Arm Title
myofascial release therapy
Arm Type
Experimental
Arm 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.
Arm Title
extracorporeal shockwave combined with myofascial release therapy
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
extracorporeal shockwave
Intervention Description
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
Behavioral
Intervention Name(s)
myofascial release
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pelvic floor muscle surface electromyography changes
Description
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.
Time Frame
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.
Title
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) changes
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Three-dimensional quantification and Shear Wave Elastography (SWE) changes
Description
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.
Time Frame
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
Title
sympathetic skin response (SSR) changes
Description
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.
Time Frame
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
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
There is no need to confirm the self-representation of gender identity
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ningqing Huang
Phone
18852068261
Email
hnq1998118@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ningqing Huang
Phone
18852068261
Email
huangningqing@seu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Ma, Doctor
Organizational Affiliation
Zhongda Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Zhongda Hospital affiliated to Southeast University
City
Nanjing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ningqing Huang, master
Phone
18852068261
Email
hnq1998118@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
No datasets were generated or analyzed during the current study. 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.
IPD Sharing 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.
IPD Sharing Access Criteria
All relevant data from this study will be made available upon study completion.
Learn more about this trial
Extracorporeal Shockwave and Myofascial Release Therapy in Chronic Pelvic Pain Syndrome
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