Effects of Therapeutic Exercises and Educational Sessions After Microdiscectomy Through Minimally Invasive Surgery for Disc Herniation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from Baseline Post Surgery (Oswestry Disability Questionnaire)
研究概览
简要总结
The basic purpose of current research is to evaluate the comparative effectiveness of therapeutic exercises and educational sessions after microdiscectomy through Minimally Invasive Surgery for disc herniation. A Randomized trial will be conducted on 60 patients from Ghurki hospital , divided into two groups. Simple random sampling will be utilized as sampling strategy. Assessment of physical activities of daily living and quality of life will be performed before and after 8 weeks of post intervention surgery through Oswestry Disability Index, Physical activity survey , SF 36 and Subjective Quality of Life scale respectively . A follow up assessment will be performed after 6 months. Analysis will be done through SPSS 21.
详细描述
The increasing number of spinal injuries and pathologies directs the need of technological advancement in spinal surgeries and its approaches in Pakistan. Among various expansion in surgical procedures; minimally invasive surgery of spine has gaining more advantage for spinal decompression, spinal fusion and instrumentation over lumbar, thoracic and cervical spine areas considering multilevel pathology.(1) Minimally invasive spine surgery (MISS), has attracted increasing attention within the last decade. The common thread between all minimally invasive spine surgeries is use of smaller incisions and less deterioration of surrounding soft tissue, typically results in less pain after surgery and a faster recovery with reduced length of stay at hospital. The patient reported functional outcome after this procedure was found to be better in comparison with the open approach procedures.(2) Therapeutic exercise post-operatively was programmed to maximize recovery and to minimize potential future problems including disability and improving quality of life. Three different approaches for post-operative management has been practiced including: 1. Recovery phase: 4 to 16 weeks of limited activity following the surgery, 2. eliminating post-operative activity restriction leads to enhanced short-term outcomes for patients after limited open discectomy, 3. Incorporating therapeutic exercise intervention program.(3) The purpose of therapeutic exercise post-operatively was to maximize recovery and to minimize potential future problems including disability and improving quality of life. (4)The therapeutic intervention program comprises of two components: patient education and exercise therapy based on protocols by clinical expertise considering the philosophy of surgeon. Patient education comprises of a one hour counseling session. Therapeutic exercise program encompasses trunk strengthening exercises (both isometrics and dynamics) along with core stabilization exercises and endurance training. (5)
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)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 20 to 50 years
- •Diagnosed cases of L4-L5 through Gold standard MRI
- •Who have undergone minimally invasive microdiscectomy due to herniated disc
- •Both male and female
- •Patients who will be without adverse events or complications 4 weeks post surgery
排除标准
- •Low back pain due to causes other than herniated disc
- •Leg pain due to causes other than herniated disc
- •Who have undergone standard/open microdiscectomy
- •Previous history of spinal surgery
- •Patients unwilling to participate
研究组 & 干预措施
Patient Education Session
Educational session will be given twice a day for three months. Individualized instructional booklet about back care for each patient will be designed, reviewed and finalized by operating surgeons according to the needs of patients.
干预措施: Patient Education Session (Other)
Therapeutic exercises plus educational sessions
Trunk and lower musculature strength and endurance training will be performed twice a week for three months. Therapeutic exercises incorporating mat exercises will be performed. Progression will be made according to patient status.
干预措施: Therapeutic Exercise plus educational session (Other)
结局指标
主要结局
Change from Baseline Post Surgery (Oswestry Disability Questionnaire)
时间窗: 3 months
The Oswestry Disability Index is considered as a vital tool that investigators and disability assessors use to measure an individual's permanent functional disability. The test is defined as the 'gold standard' of low back functional outcome tools. ODI consist of 10 items and each item is scored on Likert scale from 0 to 5. The total score is then added and multiplied by 2. Thus the score is from 0 to 100. Greater score represents more severe disability.
次要结局
- Change from Baseline Post Surgery (Quality of life Scale)(3 months)
- Change from Baseline Post Surgery (Short Form 36)(3 months)