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临床试验/CTRI/2025/07/090658
CTRI/2025/07/090658尚未招募不适用

Neurobiological and biochemical assessment of pain perception after Kalari Marma Chikitsa in Sciatica

ITRA, Jamnagar1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月30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
30
试验地点
1
主要终点
The primary outcome is to evaluate the change of leg pain intensity on the basis of VAS from baseline to week 2.

研究概览

简要总结

Kalari Marma Chikitsa is an age old method used in southern regions of India especially the state of Kerala for various neuromuscular and arthrological disorders while clinical studies regarding its efficacy for pain management in sciatica is insufficient. This study aims to explore the feasibility and efficacy of Kalari Marma Chikitsa in pain perception of sciatica patients at both clinical and biochemical levels.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
30.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients suffering from sign and symptoms of sciatica for more than 1month.
  • Patients within the age group 30-65 years, irrespective of gender, religion, occupation, and socioeconomic status will be included in the study.
  • Patients willing to undergo trial.
  • Patients with mild and moderate pain (upto grade 3) on a visual analogue scale.
  • Patients coming under the minimal and moderate disability gradation of Oswestry Low Back Pain Disability Questionnaire.

排除标准

  • Patients with red flag conditions in sciatica (muscle wasting of one or both leg, bowel or bladder dysfunction, progressive neurological deficits, saddle anesthesia, sudden onset bilateral radiculopathy, incapacitating pain and unrelenting night pain).
  • Cauda equina syndrome.
  • Fractures related to spine and hip joint.
  • Tuberculosis, other infectious disease and malignancy of lumbosacral spine.
  • Sciatica patients with associated symptoms like fever, nausea, unexplained weight loss and considerable loss of appetite will be excluded.
  • Patients of controlled hypertension.
  • Other diseases like cardiac diseases, renal diseases, endocrine disorders, severe anemia and malignancy.
  • Pregnant or lactating female.

结局指标

主要结局

The primary outcome is to evaluate the change of leg pain intensity on the basis of VAS from baseline to week 2.

时间窗: 0 day and 14 day

To assess the change in pain perception by evaluating the changes in neurotransmitter levels before and after the treatment.

时间窗: 0 day and 14 day

次要结局

  • Changes in paresthesia, stiffness and muscle power grading of muscles of affected lower limb.(Changes in ROM.)

研究者

发起方
ITRA, Jamnagar
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Ipsita Panda

Institute of teaching and research in Ayurveda

研究点 (1)

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