Pelvic Floor Muscle Training With or Without Dry Needling for Women With Chronic Pelvic Pain: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Pelvic Pain
研究概览
简要总结
The presence of trigger points in the pelvic floor musculature (PFM) is a frequent condition in individuals with chronic pelvic pain (CPP) and is associated with higher levels of pain, disability and functional decline. The purpose of this study is to test the effectiveness of two interventions: pelvic floor muscle (PFM) training with biofeedback and PFM training with the addition of trigger point dry needling applied over(Lumbar square, psoas, external obliques, gluteus medius, piriformis and adductors) on pain and quality of life of women with CPP.
详细描述
Chronic pelvic pain (CPP) is characterized as non-cyclic pain located in the distal region of the abdomen and pelvis, often refractory to conventional treatments, lasting more than six months The presence of trigger points in the pelvic floor muscles (PFM) is a frequent condition in individuals with CPP and is associated with higher levels of pain, disability and functional decline. Secondary dysfunctions associated with the clinical picture of chronic pelvic pain can be treated with muscle training through the use of biofeedback and dry needling. The purpose of this study is to test the effectiveness of two interventions: pelvic floor muscle (PFM) training with biofeedback and PFM training with the addition of trigger point dry needling applied over(Lumbar square, psoas, external obliques, gluteus medius, piriformis and adductors) on pain and quality of life of women with CPP.
We will recruit 44 women aged 18 to 60 years with CPP lasting for a minimum of six months. We will exclude women with urinary incontinence, neurological conditions, malignancy, fractures, pregnancy and those that did not agree to receive treatment with needles will be excluded.
Individuals will be randomized into two groups: PFM training with biofeedback and Dry Needling Group and PFM training with biofeedback. Participants will receive a total of 4 sessions twice a week,,for two weeks. This investigation's primary outcome will be pain (NRS) Immediately after the 4 visits. Quality of life, global impression of recovery and sexual function evaluated at Immediately after the 4 visits will be secondary outcomes.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Single-blinded (outcome assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 60 years
- •Pain in the lower pelvic and lumbar region, are not related to filling or emptying of the bladder, for more than 6 months
- •With medical diagnosis of CPP
排除标准
- •Previous spinal surgery
- •Any neurological condition
- •Fractures in the pelvic region and or lumbar spine
- •Lumbar radiculopathy.
- •Pregnancy
- •Women with difficulty in understanding written or spoken language
- •Having urinary infection or appendicitis on the day of evaluation,
- •Who are diagnosed with Post-coital bleeding, postmenopausal bleeding, unexplained abrupt weight loss, presence of visible mass on ultrasound, macroscopic or microscopic hematuria.
- •Performed some surgical intervention with general anesthesia in the last 120 days,
- •Having being received Intervesical therapy or botox in the last 90 days,
- •Aversion / phobia to needles .
研究组 & 干预措施
PFM training plus dry needling
PFM training associated with the use of dry needling over abdominal, gluteal and lombar miofascial trigger points.
干预措施: PFM training (Other)
PFM training plus dry needling
PFM training associated with the use of dry needling over abdominal, gluteal and lombar miofascial trigger points.
干预措施: Dry needling (Other)
PFM training
4 sessions (40 minutes approximately), Twice a week for 2 weeks of pelvic floor training with electromyographic biofeedback.
干预措施: PFM training (Other)
结局指标
主要结局
Pelvic Pain
时间窗: Four weeks after randomization
Numerical Pain rating scale (0-10)
次要结局
- Sexual dysfunction(Four weeks after randomization)
- Satisfaction referred by the volunteers with the treatment(Four weeks after randomization)
- Quality of life of Volunteers(Four weeks after randomization)
研究者
Mariana Della Valentina Pessoa
PT
Federal University of Health Science of Porto Alegre