跳至主要内容
临床试验/CTRI/2024/07/069988
CTRI/2024/07/069988尚未招募不适用

Assessment of spinopelvic parameters in the normal Indianpopulation and comparison with patients of chronic backache An observational study

AIIMS Bathinda1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2024年7月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
122
试验地点
1
主要终点
(degenerative spine disease) with respect to the following parameters: TK, LL,SLA, LSA, C7SVA, PI, SS, PT

研究概览

简要总结

Aim

Assessment of spinopelvic parameters in the normal Indian population and comparison with

patients of chronic low backache : An observational study

Objectives

Primary Objectives

  • To compare the sagittal spinopelvic parameters in asymptomatic v/s diseased population

(degenerative spine disease) with respect to the following parameters: TK, LL,SLA, LSA,

C7SVA, PI, SS, PT

Secondary Objectives

  • To assess normal radiolographical parameters in Indian population and compare with

patients with chronic low backache.

  • To assess variability among asymptomatic controls with respect to age, sex, BMI, type of

work (hard labor v/s sedentary).

  • To look for markers predicting the onset or prognosticating the course of degenerative

spine disease.

Materials and Methods

  1. Study Design:

Observational, case control study

  1. Study Population:

Adult patients of age 18-60 years presenting to the Orthopaedics OPD of All India

Institute of Medical Sciences, Bathinda asymptomatic with respect to disorders of

spine (refer exclusion criteria) and patients presenting with complain of low

backache diagnosed as case of degenerative spine disease by a senior, experienced

orthopaedic spine surgeon.3)

Study Area: Department of Orthopaedics, All India Institute of Medical Sciences, Bathinda

  1. Study Duration: 2 years

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Inclusion criteria Consenting adults between 18-50 years age Complaint of chronic low backache (>12 weeks) Clinically diagnosed as a case of degenerative spine disease by an experienced spine surgeon.

排除标准

  • Exclusion criteria Not consenting <18 years or > 50 years of age Systemic and metabolic disease affecting bone (like RA) Evidence of foot, ankle, knee or hip pathology Evidence of spine pathology Evidence of acute or chronic trauma History of spine surgery Evidence of malignancy or spinal metastasis Females with positive urine pregnancy test Females taking treatment to conceive, or planning conception during or before recruitment Females with history of multiple miscarriages/ birth defects.

结局指标

主要结局

(degenerative spine disease) with respect to the following parameters: TK, LL,SLA, LSA, C7SVA, PI, SS, PT

时间窗: 1 month

- To compare the sagittal spinopelvic parameters in asymptomatic v/s diseased population

时间窗: 1 month

次要结局

  • - To assess normal radiolographical parameters in Indian population & compare with(patients with chronic low backache. - To assess variability among asymptomatic controls with respect to age, sex, BMI, type of)

研究者

发起方
AIIMS Bathinda
申办方类型
Government medical college

研究点 (1)

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