Effectiveness of an 8 week Physiotherapy intervention program for Rural Women having Lumber Disc Herniation with cauda Equina Syndrome in Jashore, Bangladesh.
试验速览
- 阶段
- 不适用
- 状态
- Not Applicable
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- pain at rest, sitting and standing in VAS scale, Neurological evaluation by ASIA impairment scale, and PVR by ultrasonography
研究概览
简要总结
Background – Cauda equina syndrome (CES) is a complication associated with lumbar disc herniation (LDH). Women in rural lower-middle income countries (LMIC) pose a greater risk of impairments to bladder and bowel control, sensory and motor functions, and may experience increased pain intensity due to a lack of accessibility to rehabilitation services. Physiotherapy management, the McKenzie technique and Kegels have previously demonstrated a positive impact on pain intensity, bowel and bladder control, and functioning in patients with LDH and CES. This study aims to explore the effectiveness of an eight-week Physiotherapy intervention in women with LDH and CES living in rural Bangladesh and their experiences of receiving rehabilitation.
Methods – The study will be a mixed method using one arm pre and post-test design and in-depth interview with a convenience sampling will be carried out to evaluate the effectiveness of a Physiotherapy intervention program in women from rural villages surrounding Jashore, Bangladesh over an eight-week period. Data will be collected from the participants through pre-post-test outcome measures: Pain intensity using the Visual analogue Scale, neurological function through the American Spinal Injury Association (ASIA) assessment, bladder function using an ultrasonographic evaluation of post-void residual volume, pelvic floor function including strength and endurance using a dynamometer. Functioning will be measured through the Oswestry low back disability Index as a secondary outcome. Data will be analyzed using a paired t-test and regression analysis. Focus group interviews will also be conducted with a sub-sample of participants to explore their experiences of the intervention and receiving rehabilitation. This data will be analyzed using an inductive thematic reflexive approach. A concurrent triangulation approach will be adopted with quantitative and qualitative data being integrated at the point of interpretation and presented in a joint-display table.
Discussion – This study aims to provide short-term rehabilitation and promote long-term self-management techniques to marginalized women with the highest risk of disability to enhance their physical and functional ability, social life and engagement in activities of daily living. We will reach a community that may otherwise have not sought treatment due to a lack of time and resources.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- Female
入选标准
- •Low back pain with lower limb radicular symptoms 2) Lasegue sign and cross lasegue sign positive 3) Post Void Residuals purine volume more than 50 ml 4) Magnetic Resonance Imaging evidence of Lumbar disc herniation in single or multiple levels.
排除标准
- •Degenerative Disc Disease of Lumbar spine 2) Any history of disc or spine surgery 3) Uncontrolled endocrine or metabolic disease.
- •Unwilling.
结局指标
主要结局
pain at rest, sitting and standing in VAS scale, Neurological evaluation by ASIA impairment scale, and PVR by ultrasonography
时间窗: 56 days
次要结局
- disability by Oswestry disability index(56 days)
研究者
K M Amran Hossain
Jashore University of Science & technology
