Comparing two Manual therapy approaches along with Inpatient medical care for women having Cauda equina syndrome due to Prolapsed lumbar intervertebral disc
试验速览
- 阶段
- 2 期
- 状态
- Not Applicable
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Primary outcomes of the study will be (1) pain measured by a 10cm visual analogue scale; (2) neurological functions measured by (i) straight leg raise degrees, (ii) dural sign, examination of lumbosacral (iii) dermatome, and (iv) myotome; (3) bladder control evaluated by post-void residual volume of urine by ultrasonography; and (4) pelvic floor muscle strength measured by ActivForce 2™ dynamometer.
研究概览
简要总结
There is a considerable research gap on manual therapy approaches for patients having PLID who choose conservative care, even with mild to moderate neurological impairments. This study aims to compare the effectiveness of two manual therapy approaches on women having CES due to PLID. We will evaluate the outcome of a new approach named Structural diagnosis and management (SDM), compared to the Mechanical diagnosis and therapy (MDT) of the lumbar spine. We planned a Randomized clinical trial (RCT) on 112 women admitted for conservative management of PLID at the inpatient unit of a specialized physiotherapy center. Between August and September 2025, women with PLID who have symptoms of CES attending the Outpatient unit of the center will be screened and invited to participate in the trial. Confirmation of PLID will be made by clinical examination and Magnetic resonance imaging (MRI) of the lumbosacral spine. After obtaining informed consent, patients will be randomly allocated to either the SDM (n=56) or the MDT (n=56) groups on two different floors of the facility. Both groups will receive two different manual therapy concepts targeting lumbar paravertebral structures in two sessions every day, each lasting 30-45 minutes at the inpatient unit for 14 days. In addition, both groups will receive medications, nursing care, and nutritional advice from a multidisciplinary team. Both groups will also receive customized home exercises for another 2 weeks after discharge from the inpatient care facility. We will follow the ethical standards of good clinical practice (ICH-GCP) and adhere to the Consolidated Standards of Reporting Trials (CONSORT). To ensure the rigor of the trial, we will ensure a separate trial and data management team, conduct block randomization during concealed allocation, and ensure appropriate monitoring and reporting of the adverse events and surgical referral.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Prolapse Lumbar intervertebral disc with cauda equina syndrome diagnosed according to the North American Spine Society guideline, magnetic resonance imaging MRI and willing to be treated in nonsurgical management.
排除标准
- •Participants will be excluded if they underwent surgery for PLID before the recruitment or were referred for surgery after the recruitment, have comorbidities that might affect the outcome as obesity, metabolic disease, uncontrolled hypertension or diabetes, early menopause, degenerative disc disease in MRI, and drop-out or withdrawal of participation within first week of recruitment.
结局指标
主要结局
Primary outcomes of the study will be (1) pain measured by a 10cm visual analogue scale; (2) neurological functions measured by (i) straight leg raise degrees, (ii) dural sign, examination of lumbosacral (iii) dermatome, and (iv) myotome; (3) bladder control evaluated by post-void residual volume of urine by ultrasonography; and (4) pelvic floor muscle strength measured by ActivForce 2™ dynamometer.
时间窗: Day 1, day 30, and Day 90
次要结局
- Disability in the Oswestry low back disability index (ODI)(Day 1, Day 30, Day 90)
研究者
Sapia Akter
Jashore University of Science & Technology