Effects of Extracorporeal Shockwave Therapy Versus Pulsed Electromagnetic Field Therapy in Females With Sexual Dysfunction: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
研究概览
简要总结
This is a prospective, three-arm, parallel-group, assessor-blinded randomized controlled trial designed to compare the effectiveness of extracorporeal shockwave therapy (ESWT) combined with pelvic floor muscle training (PFMT), pulsed electromagnetic field stimulation (PEMF) combined with PFMT, and PFMT alone in Females with sexual dysfunction. Participants will be randomly allocated in a 1:1:1 ratio, and the study duration is 16 weeks, including an 8-week intervention period and an 8-week follow-up period.
详细描述
Female sexual dysfunction is a multifactorial condition involving physiological, vascular, neuromuscular, and psychosocial components, and pelvic floor dysfunction and impaired genital blood flow are recognized contributing factors. Therefore, this trial integrates both neuromuscular rehabilitation and non-invasive energy-based modalities to target different underlying mechanisms of FSD.
A total of 90 women diagnosed with FSD based on a Female Sexual Function Index (FSFI) score < 26.55 will be recruited and randomly assigned in a 1:1:1 ratio to one of three groups. The ESWT + PFMT group will receive low-intensity radial extracorporeal shockwave therapy once weekly for 8 weeks, applied to the perineum and pelvic floor trigger points, in addition to a standardized pelvic floor muscle training program performed three times weekly under supervision. The PEMF + PFMT group will receive pulsed electromagnetic field stimulation three times weekly for 8 weeks, combined with the same standardized PFMT protocol. The PFMT-only group will perform identical supervised pelvic floor muscle training without adjunct device-based therapy.
Randomization will be performed using a computer-generated sequence with block randomization, and allocation will be ensured using sealed opaque envelopes. Outcome assessors will be blinded to group allocation to reduce assessment bias.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged 20-50 years diagnosed with female sexual dysfunction (FSFI score <26.55), reporting symptoms of reduced sexual desire, arousal dysfunction, orgasmic dysfunction, or dyspareunia.
- •Premenopausal women in a stable sexual relationship for at least 6 months and sexually active during the previous month.
- •Symptoms persisting for at least 3 months before enrollment.
- •Ability to understand study procedures and provide written informed consent.
- •Willingness to refrain from initiating any additional treatment for sexual dysfunction during the study period
排除标准
- •Pregnancy or planned pregnancy during the study period.
- •Pelvic surgery within the previous 6 months.
- •Active pelvic inflammatory disease, genital infection, or unexplained vaginal bleeding.
- •Neurological disorders affecting pelvic floor or sexual function.
- •Severe pelvic organ prolapse, severe urinary incontinence, or significant pelvic anatomical abnormalities.
- •Current hormonal therapy or use of medications known to affect sexual function, including antidepressants or antipsychotics.
- •Severe psychiatric disorders or cognitive impairment limiting participation.
- •Menopause or perimenopausal status.
- •Uncontrolled systemic diseases such as diabetes mellitus, hypertension, cardiovascular disease, or thyroid disorders.
- •Presence of malignancy, pelvic radiation history, or severe chronic pelvic pain disorders.
- •Contraindications to ESWT or PEMF including cardiac pacemakers or implanted electronic devices, coagulation disorders, anticoagulant therapy, epilepsy, or metal implants in the pelvic region.
- •Current participation in another clinical trial or receipt of physiotherapy for sexual dysfunction within the previous 3 months.
研究组 & 干预措施
PEMF + PFMT
Participants will receive pulsed electromagnetic stimulation combined with the same standardized pelvic floor muscle training program
干预措施: Pelvic floor muscle training (Other)
ESWT + PFMT
Participants will receive low-intensity extracorporeal shockwave therapy and participants will perform a standardized pelvic floor muscle training program
干预措施: low-intensity extracorporeal shockwave therapy (Other)
ESWT + PFMT
Participants will receive low-intensity extracorporeal shockwave therapy and participants will perform a standardized pelvic floor muscle training program
干预措施: Pelvic floor muscle training (Other)
PEMF + PFMT
Participants will receive pulsed electromagnetic stimulation combined with the same standardized pelvic floor muscle training program
干预措施: Pulsed electromagnetic field stimulation (Other)
PFMT (Control)
Participants will receive a standardized pelvic floor muscle training program
干预措施: Pelvic floor muscle training (Other)
研究者
Mahmoud Hamada Mohamed
Associate Professor of Physical Therapy
Benha University