To Investigate the Use of Trans-perineal Trigger Point Dry Needling With Manual Therapy and to Compare the Outcome With Manual Therapy Treatment for Chronic Pelvic Pain With Dyspareunia. A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Pain reduction or resolution within 10 treatment sessions, evaluated with the 0-10 Numeric Pain Rating Scale (0-10NPRS)
研究概览
简要总结
Chronic Pelvic Pain (CPP) are around 10% of gynaecology referrals.Non-relaxing pelvic floor dysfunction (NRPFD) is an under-appreciated cause for CPP with dyspareunia where no other pathology exists. The effectiveness of manual therapy in studies have shown statistically significant pre and post treatment differences.However no study has reviewed the efficacy of inclusion of trans- perineal trigger point dry needling used with manual therapy for NRPFD. This study will investigate the effectiveness of trans-perineal trigger point dry needling used with manual therapy techniques for CPP.
详细描述
This study will investigate the effectiveness of inclusion of trans-perineal trigger point dry needling with manual therapy treatment for chronic pelvic pain with dyspareunia and associated pelvic floor dysfunctions.The use of trigger point dry needling (TrptDN) for chronic low back pain has proved beneficial.This study will evaluate the treatment outcomes of trans-perineal trigger point dry needling and manual therapy to only manual therapy for CPP.
The outcomes will evaluate the number of treatment requirements between the dry needling with manual therapy group and the manual therapy group and review which group has faster resolution in pain and other associated pelvic floor symptoms.
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
- None
盲法说明
It is difficult to mask the participants or care provider due to the nature of the therapy. The outcome questionnaires are filled in individually by the participants only.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients reporting non-cyclical CPP with dyspareunia and associated PFD with no palpable pelvic floor pathology, but with palpable high pelvic floor muscle (PFM) tone and tenderness will be referred for physiotherapy by the gynaecology team.
- •Visceral conditions like interstitial cystitis are difficult to exclude at gynaecology review, as they mimic CPP symptoms.
- •Smokers and non-smokers included.
- •Nulliparous, singleton and multiparous patients.
排除标准
- •Body mass index greater than 30, makes it difficult to dry needle as the required needle length is not available.
- •Chronic back pain over 6 months duration, under pain management team.
- •Orthopaedic back surgeries with implants.
- •Pelvic pathologies like endometriosis, fibroids, cysts, etc.
- •Pregnancy related pelvic pain.
- •Pregnant during the trial.
- •Pelvic organ carcinomas.
- •Undergoing cancer treatment.
- •Post gynaecology surgeries, less than 16 weeks.
- •Cardiovascular, gastroenterology, renal or orthopaedic surgery, less than 6 month's post-operative.
- •Neurological conditions like stroke, epilepsy, Parkinson's disease etc.
- •Exclusion criteria for dry needling:
- •Extreme needle phobia, Rheumatoid arthritis, prolonged corticosteroid treatment, warfarin treatment, heart implants and blood clotting disorders.
- •Participant with no significant learning disability and should be able to understand the procedure to consent for treatment.
- •Participant should not require a chaperone during treatment.
研究组 & 干预措施
Manual therapy
Intervention to be administered is manual therapy with myofascial release of trigger points for pelvic floor muscles, pelvis and abdominal musculature.
干预措施: Manual therapy (Procedure)
Dry needling & manual therapy
Intervention to be administered is Trans-perineal trigger point dry needling, done externally to target the trigger points in the pelvic floor muscles along with dry needling of the pelvis and abdominal musculature.Manual therapy will only be used in areas difficult to reach with the acupuncture needles.
干预措施: Manual therapy (Procedure)
Dry needling & manual therapy
Intervention to be administered is Trans-perineal trigger point dry needling, done externally to target the trigger points in the pelvic floor muscles along with dry needling of the pelvis and abdominal musculature.Manual therapy will only be used in areas difficult to reach with the acupuncture needles.
干预措施: Trigger point dry needling (Procedure)
结局指标
主要结局
Pain reduction or resolution within 10 treatment sessions, evaluated with the 0-10 Numeric Pain Rating Scale (0-10NPRS)
时间窗: 10 weeks or earlier on resolution
Participants will be asked to fill the 0-10NPRS at base line, 4th, 8th and 10th session or earlier on resolution of symptoms and to review which arm has faster resolution with lesser treatment sessions.
次要结局
- Patient treatment satisfaction in each group(10 weeks or earlier on resolution)
- Resolution in dyspareunia(10 weeks or earlier on resolution)
- Resolution in bladder, bowel and sexual dysfunction(10 weeks or earlier on resolution)
研究者
Shalini Wiseman
Senior Physiotherapist in Women's Health & Continence
Cork University Hospital