Chronic Pelvic Pain SyndromeNCT05659199
Extracorporeal Shockwave and Myofascial Release Therapy in Chronic Pelvic Pain Syndrome
A study testing extracorporeal shockwave and myofascial release in people with Chronic Pelvic Pain Syndrome, run by Zongda Hospital affiliated to Southeast University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men only
- Conditions the study is for
- Chronic Pelvic Pain Syndrome
- What is being tested?
- extracorporeal shockwave and myofascial release
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Zhongda Hospital affiliated to Southeast University
Nanjing
Ningqing Huang, master, 18852068261, hnq1998118@163.com
About this study
Official title: Study on the Intervention of Extracorporeal Shockwave Therapy and Myofascial Release Therapy in Chronic Pelvic Pain Syndrome
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.
Read the 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
- Being tested
- extracorporeal shockwave, myofascial release
- Keywords
- chronic pelvic pain syndrome, extracorporeal shockwave, myofascial release therapy, surface electromyography, sympathetic skin response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extracorporeal shockwaveDevice
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 releaseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Device: extracorporeal shockwave; Behavioral: myofascial release |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Pelvic Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- fascia trigger point release group extracorporeal shock wave group extracorporeal shock wave and fascial trigger point release treatment group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zongda Hospital affiliated to Southeast University
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Ming Ma, Doctor, Study director, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659199
- Sponsor's protocol ID
- ZongdaH
- Status last verified
- Dec 2022
- First submitted
- 9 Dec 2022
- Last updated
- 3 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37853420
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Intervention of Extracorporeal Shockwave Therapy and Myofascial Release Therapy in Chronic Pelvic Pain Syndrome
- ClinicalTrials.gov ID
- NCT05659199
- Acronym / sponsor ID
- ZongdaH
- Conditions
- Chronic Pelvic Pain Syndrome
- Keywords
- chronic pelvic pain syndrome, extracorporeal shockwave, myofascial release therapy, surface electromyography, sympathetic skin response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Zongda Hospital affiliated to Southeast UniversityResearch network
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- fascia trigger point release group extracorporeal shock wave group extracorporeal shock wave and fascial trigger point release treatment group
| Arm | Type | Receives |
|---|---|---|
| extracorporeal shockwave therapy | Experimental | Device: extracorporeal shockwaveextracorporeal 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 therapy | Experimental | Behavioral: myofascial releasemyofascial 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. |
| extracorporeal shockwave combined with myofascial release therapy | Experimental | Device: extracorporeal shockwave, Behavioral: myofascial releaseCombined 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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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);
Key exclusion criteria (5 listed)
- ① Patients with significant coagulation disorders, perineal anatomical abnormalities, hormonal abnormalities and neurological abnormalities;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extracorporeal shockwavePatients 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 combined with myofascial release therapy, extracorporeal shockwave therapy |
| myofascial releasepressure 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. | Behavioural | extracorporeal shockwave combined with myofascial release therapy, myofascial release therapy |
Primary outcome
Pelvic floor muscle surface electromyography changes
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.
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
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
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.
2 secondary outcomes
Three-dimensional quantification and Shear Wave Elastography (SWE) changes
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
sympathetic skin response (SSR) changes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2023.
- Derived from this study: PubMed 37853420Huang 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Ma, Doctor study director
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extracorporeal shockwave and myofascial release in people with Chronic Pelvic Pain Syndrome, run by Zongda Hospital affiliated to Southeast University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ningqing Huang (18852068261, hnq1998118@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic floor muscle surface electromyography changes (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05659199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2023.