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临床试验/CTRI/2024/11/077279
CTRI/2024/11/077279招募中不适用

Effectiveness of Individualized Homoeopathic Medicines in Pain and Health-Related Quality of life in Patients with Sciatica using Synthesis Repertory: A Single Group, Pre-Post Interventional Study

Dr Soumitra Bose1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月2日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Reduction in the pain of sciatica measured using Numerical Pain Rating Scale (NPRS)

研究概览

简要总结

INTRODUCTION: Hippocrates was, the first physician to use the term ‘sciatica’, deriving from the Greek ‘’ischios’’, hip. Sciatica (ME84.3 as per ICD-11) is commonly used to describe radiating leg pain. It is caused by inflammation or compression of the lumbosacral nerve roots (L4-S1) forming the sciatic nerve. A crucial function of the sciatic nerve is to provide direct motor activity to the hamstrings and lower extremity adductors, as well as indirect motor function to the anterior lower leg muscles, calf muscles, and select intrinsic foot muscles. Furthermore, its terminal branches indirectly contribute to sensation in the posterior and lateral lower leg and the plantar aspect of the foot. Importantly, sciatica predominantly arises from an inflammatory condition, leading to sciatic nerve irritation. Conversely, direct nerve compression results in more pronounced motor dysfunction, necessitating a thorough and prompt diagnostic evaluation if present. From a maximum incidence of 40%, the prevalence of sciatica varies greatly between research. Most instances occur in life’s fourth and fifth decades. In conservative treatment pain medications have uncertain benefits for sciatica and can have adverse effects, because of their role and use only very sparsely for a short period (weeks rather than months) and in the lowest possible dose for pain relief. Corticosteroids may improve symptoms for a short period (six weeks), as compared to a placebo. In Homeopathy, we do not treat based on the name of the disease, i.e. sciatica, but we treat the patients as a whole using constitutional medicines based on a summary of symptoms. These drugs reduce pain and limit disability. There have been many studies on sciatica in other areas, but very few works have been done in homoeopathy. This study presents cases clinically and radio-logically diagnosed as sciatica and their response to individualized homeopathic medicine in the context of pain via the Numerical Pain Rating Scale (NPRS) and changes the overall health-related quality of life by using the Oswestry Low Back Pain Disability Questionnaire (OLBPDQ) and with the help of the Synthesis repertory.

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
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients experiencing low back pain radiating to lower limb (unilateral or bilateral) since 3 months or more; confirmed by Straight leg raise (SLR) test.
  • Cases of sciatica with following symptoms: (1) Constant or intermittent pain anywhere in the course of sciatic nerve.
  • (2) Sharp, Shooting pain anywhere in the course of sciatic nerve.
  • (3) Burning or tingling sensation anywhere in the course of sciatic nerve.
  • Patients of age group 18 – 65 years.
  • Person not taking any other medicines either Homoeopathic or other forms for the last 1 month for the same suffering.

排除标准

  • Patients suffering from uncontrolled endocrine disorders, cardiovascular diseases and other uncontrolled or life-threatening illnesses affecting quality of life or any organ failure.
  • Spinal corticosteroid injection within 6 months.
  • Diagnosed psychological, personality, and neurological disorders such as dementia, Alzheimer’s disease, and parkinsonism.
  • Chronic alcoholism and substance abuse.
  • Pregnancy and lactating ladies.

结局指标

主要结局

Reduction in the pain of sciatica measured using Numerical Pain Rating Scale (NPRS)

时间窗: Each patient will get follow-up for at least 3 months at the interval of 1 month

次要结局

  • Improvement in quality of life assessed using Oswestry Low Back Pain Disability(Questionnaire (OLBPDQ).)

研究者

发起方
Dr Soumitra Bose
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Soumitra Bose

Mahesh Bhattacharyya Homoeopathic Medical College and Hospital

研究点 (1)

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