Impact of pain severity on physical performance and quality of life among low back pain subjects: a cross-sectional observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Timed up and go test (TUG)
研究概览
简要总结
BACKGROUND
It’s common for individuals to experience low back pain (LBP) at some point in their lives, which is typically harmless and lasts for a few days or weeks. LBP affects the lumbar region of the spine, located between the hips and the bottom of the ribcage, and is often associated with muscle tension that limits movement. While the prevalence of LBP varies across populations, disability due to back pain is the leading cause of activity limitation for adults under 45 years old and second only to arthritis for those aged 45 to 65 years old. Prevalence refers to the number of individuals in a defined population who have a specific disease or condition at a given time (Jekel J, Elmore J, Katz D. Epidemiology, Biostatistics, and preventative medicine. Toronto, Ontario, Canada: WB Saunders Co;1996: 20-22). In India, the point, annual, and lifetime prevalence rates of LBP were 48% (95% CI 40-56%), 51% (95% CI 45-58%), and 66% (95% CI 56-75%), respectively, with higher rates among females, rural populations, and elementary workers. However, data on LBP prevalence and risk factors are limited in developing countries like India. Therefore, this study aims to fill this gap by investigating the relationship between pain severity and critical outcomes.
AIM:
To study the pain severity on performance and quality of life in individuals with Low Back Pain.
OBJECTIVE:
Primary objective:
➢ To explore the association between pain severity and physical performance.
Secondary objectives:
➢ To investigate the pain severity on health-related quality of life(HRQoL)
➢ To examine the effect of LBP using SF-36 Questionnaire and Timed up and go Test(TUG)
➢ To analyze the effect of LBP using the Numeric rating scale(NRS).
Need for the Study:
While previous research has established the impact of LBP on various aspects of well-being, there remains a gap in understanding how pain severity specifically affects physical performance and quality of life. This study seeks to address this gap by examining the relationship between pain severity and these critical outcomes.
Procedure:
Institutional Ethical Committee, SRIHER will be obtained and the Study will be registered in the Clinical Trial Registry of India. The participants will be screened for eligibility criteria. Once the participant fulfils the inclusion criteria, informed consent will be obtained and all baseline outcome measures will be recorded. The study will measure pain severity in participants using a Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Next, the participant will perform the Timed Up and Go (TUG) test, which involves standing up from a seated position, walking up to 3 meters, returning to the starting point, and sitting down on a chair while the time is recorded. Finally, the participant will complete a set of questionnaires that assess their Health-Related Quality of Life (HRQoL) using a survey similar to the SF-36.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)(—)
- 性别
- All
入选标准
- •Subjects identified with LBP.
排除标准
- •Exclusion criteria: Healthy people.
- •People with walking aids.
- •Subjects who had spinal fractures or surgery.
- •People who are unable to understand instructions due to cognitive impairment.
- •Pain Score of more than 7 in NRS.
结局指标
主要结局
Timed up and go test (TUG)
时间窗: At baseline
Health-related Quality of Life(SF-36 questionnaire)
时间窗: At baseline
次要结局
- Numeric rating scale (NRS)(At baseline)
研究者
Mr S J GHOKKUL
Sri Ramachandra Institute of Higher Education and Research[Deemed to be university]
