Study on the Intervention of Extracorporeal Shockwave Therapy and Myofascial Release Therapy in Chronic Pelvic Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Pelvic floor muscle surface electromyography changes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: extracorporeal shockwave (Device)
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.
干预措施: myofascial release (Behavioral)
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
干预措施: extracorporeal shockwave (Device)
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
干预措施: myofascial release (Behavioral)
结局指标
主要结局
Pelvic floor muscle surface electromyography changes
时间窗: 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
时间窗: 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.
次要结局
- 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)
- 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)