A comparative study between fluoroscopy guided percutaneous vertebroplasty and teriparatide injection in treatment of acute and subacute osteoporotic vertebral compression fracture.
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
- 1
- 主要终点
- Reduction in pain measured by Visual Analogue Scale
研究概览
简要总结
Proposed topic of research:
A COMPARATIVE STUDY BETWEEN FLUOROSCOPY GUIDED PERCUTANEOUS VERTEBROPLASTY AND TERIPARATIDE INJECTION IN TREATMENT OF ACUTE AND SUBACUTE OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURE.
Objective of proposed research:
To compare the efficacy of vertebroplasty and teriparatide injection in pain relief and improving quality of life in patients with osteoporotic vertebral compression fracture.
Research hypothesis:
Significant Pain relief in osteoporotic vertebral compression fracture patients following vertebroplasty over teriparatide injection, and immediate relief following procedure.
Background of present study:
Osteoporotic vertebral compression fractures(OVCFs) are very common in elderly population with osteoporosis all over the world. In India, high prevalence of vertebral fractures can be observed. Lower socio-economic status, inadequate dietary intake, sedentary lifestyles, younger age at puberty, multiparity and early age of menopause in case of females in comparison to other countries and lack of any lifestyle modifications in older persons aggravates osteoporosis and also Osteoporotic Vertebral Compression Fractures (OVCF) among Indian population. At present OVCF is primarily managed conservatively, among which Injection Teriparatide is one the anabolic agents which is used for its bone forming and bone remodeling property. But with conservative treatment many times, responses are inadequate and immediate pain relief is not achieved, as per various literature evidences. Recent advanced procedure for these cases is hereby mentioned in different studies. Percutaneous vertebroplasty is one such procedure used for treatment of pain in these patients, but there is lack of evidences regarding head-to-head comparative study between efficacy of percutaneous vertebroplasty and conservative management for pain relief in OVCF. So, this is our humble approach to compare vertebroplasty and teriparatide injection in treatment of painful osteoporotic vertebral compression fractures.
Methodology:
• Study design / Experiment design: Parallel group, open label randomized controlled trial
• Study duration: 18 months
• Place of study: Department of Physical Medicine & Rehabilitation (PM&R), IPGME&R and SSKM Hospital, Kolkata
• Study population: Patients attending OPDs of Department of PM&R, IPGME&R, fulfilling inclusion and exclusion criteria.
• Sample size: total 38 (19 in each group)
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient diagnosed as Osteoporosis as per WHO criteria [T score of + -2.5].
- •Vertebral compression fracture on spine radiograph (minimum height loss 15%).
- •Low back pain for last 6 months or less.
- •Visual analogue scale (VAS) score > 3.
排除标准
- •Spinal instability
- •Radicular pain or Radiculopathy
- •Abnormal coagulation profile
- •Systemic or local infection
- •Severe cardio-pulmonary comorbidities, uncontrolled liver and kidney diseases
- •Uncontrolled Diabetes mellitus
- •Underlying malignant disease
- •Loss of vertebral height ≥80% or vertebra plana, pedicle fracture, burst fracture and Scoliosis
- •Greater than 3 compression fractures
- •Patient’s refusal
- •Allergy to local anesthetic or PMMA, or Teriparatide.
结局指标
主要结局
Reduction in pain measured by Visual Analogue Scale
时间窗: 6 month
次要结局
- Quality of Life measured by using QUALEFFO 41 questionnaire.(6 month)