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临床试验/CTRI/2025/04/084533
CTRI/2025/04/084533尚未招募2 期

Effectiveness of Primal reflex release technique on lumbar lordosis, lumbar range of motion, trunk flexibility, sleep and wake behaviuor in patients with chronic low back pain

Mugdha Kumari1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年4月18日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
48
试验地点
1
主要终点
Lumbar range of motion, lumbar lordosis, trunk flexibility, sleep and wake behaviour

研究概览

简要总结

Chronic back pain is defined as back pain that persists for 12 weeks or longer even after an initialinjury or underlying cause of acute back pain has been treated. IT is a common health issue that can significantly impact quality of life, including physical activity, mental health and overall productivity. Chronic back pain affects about 10-20% of adults globally, depending on the population and study methods. It is one of the most common reasons for disability world wide.The primal reflex release technique is a treatment paradigm theorized to decrease pain and muscle spasm by targetting, resetting reflexes and using reciprocal inhibition to down regulate the autonomic nervous system. This study aims to determine the effectiveness of primal reflex release technique on lumbar lordosis, lumbar range of motion, trunk flexibility and sleep and wake behaviour in patients with chronic low back pain.

This study will be a randomized control trial and will be conducted at SGT Hospital in Gurugram. A sample size of 48 patients will be taken in this study using convenient sampling technique. Patients will be randomly assigned into two groups.

Group  A will be treated by Primal reflex release technique and group B will be treated by conventional exercise. Lumbar lordosis and lumbar range of motion will be measured by inclinometre, trunk flexibility by fingertip to floor test and pittsburg sleep diary to know about the sleep and wake behaviour. The evaluation will be done on day 1 as pretreatment values and at 4 week as post treatment values  respectively.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Patient age between 18 to 45 years either of the gender Patient having low back pain for more than 3 months Pain intensity greater than 3 on 0 to 10 numerical pain rating scale Patient who is not undergoing any treatment.

排除标准

  • Any neurological deficit, History of surgery, Any diagnosed respiratory conditions, Psychiatric disorders, Pregnancy, Any medication which may affect sleep, Diagnosed with sleep disorders(insomnia),PIVD, Underlying condition (such as cancer, infection or cauda equina syndrome), Spinal stenosis, Radiating pain occurring in the back.

结局指标

主要结局

Lumbar range of motion, lumbar lordosis, trunk flexibility, sleep and wake behaviour

时间窗: At baseline, at the end of 4 week

次要结局

未报告次要终点

研究者

发起方
Mugdha Kumari
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Mugdha Kumari

SGT University

研究点 (1)

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