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临床试验/CTRI/2024/12/077877
CTRI/2024/12/077877尚未招募不适用

Effect of Individualized homoeopathic medicines on pain and health related quality of life in patients of cervical spondylosis : A single group, pre - post interventional study

Mahesh Bhattacharyya Homoeopathic Medical College And Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月18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
To understand the impact on pain by using Numeric Pain Rating Scale.

研究概览

简要总结

INTRODUCTION: Cervical Spondylosis (ICD-11, 2023; FA8Z)  is a characterized by degenerative disorder of cervical spine, intervertebral discs, ligaments and cartilaginous material and osteophyte formation. Spondylosis may be associated with neurological dysfunction.“SPONDYLO” is a Greek word meaning vertebra and spondylosis generally mean changes in the vertebral joint characterized by increasing degeneration of the intervertebral disc with subsequent changes in the bones and soft tissues.It affects the vertebral bodies and intervertebral discs of the neck and leads to herniated intervertebral disks, osteophytes, and ligament hypertrophy. This may eventually cause compression of the nerve roots and spinal cord. The typical signs and symptoms of cervical spondylosis include headaches, neck stiffness, vertigo, numbness, weakness, and tingling in the arms and/or neck, as well as pain in these areas.The typical age range for individuals with cervical spondylosis is 40–60 years old, with a male to female ratio of 3:1. The highest frequency was seen between 40 to 49 years of age. Men the majority was seen starting around age 20."Vertebral osteophytosis secondary to degenerative disc disease" is the definition of spondylosis. Spondylosis is not the same as inflammatory diseases that cause osteophyte development, which are all referred to as arthritis.

Age-related degradation of the cervical spinal components and intervertebral disc is the main risk factor and contributor to the incidence of cervical spondylosis. Narrowing of the spinal canal and intervertebral foramina is caused by degenerative alterations in surrounding structures, such as the facets joints, uncovertebral joints, posterior longitudinal ligament (PLL), and ligamentum flavum. Axial neck discomfort, cervical myelopathy, and cervical radiculopathy are the three clinical symptoms that cervical spondylosis manifests as a result of compression of the spinal cord, spinal vasculature, and nerve roots. Certain sports activities like rugby, soccer, and horseback riding, as well as congenitally narrow vertebral canals and dystonic cerebral palsy that affects the cervical musculature, can all lead to an accelerated disease process and early-onset cervical spondylosis.The majority of patients with radiographic imaging-detected spondylotic alterations of the cervical spine are asymptomatic; 25% of patients under 40, 50% of patients over 40, and 85% of patients over 60 exhibit some degree of degenerative abnormalities. Levels C6–C7 are the most commonly impacted, followed by C5–C6. The most prevalent symptom of symptomatic cervical spondylosis is neck pain. Neck discomfort in the general population can have a point prevalence of 0.4% to 41.5%, a 1-year incidence of 4.8% to 79.5%, and a lifetime prevalence of up to 86.8%. Low back and neck pain is still the primary cause of years lived with disability (YLD) and the fourth most common cause of impairment, according to the Global Burden of Disease report from 2015.In homoeopathy, the idea of "individualization" is embraced, meaning that different patients with the same illness can be treated with different medicines based on their unique physical, mental, and miasmatic symptoms.

RESEARCH QUESTIONS: Is individualized homoeopathic medicines are effective on pain along with health related quality of life in the patients suffering from cervical spondylosis?

HYPOTHESIS:A) Null Hypothesis(H0): There is no significant role of individualized homoeopathic medicines in the treatment of Cervical Spondylosis.B) Alternative Hypothesis (HA): Individualized homoeopathic medicines have a significant role in the treatment of Cervical Spondylosis.

JUSTIFICATION OF STUDY :

Hogg-Johnson et al. conducted a review of the epidemiology of neck pain and discovered that the annual prevalence of neck pain in the general adult population and workers ranged from 12.1% to 71.5%. In the allopathic system of medication consists of topical analgesics, NSAIDs, analgesics and injections which have side effects that are more serious than the illness.In modern era the prevalence of Cervical Spondylosis in adult age group is rising very high due to working conditions, (such as posture and neck muscle endurance) have not been prospectively investigated specifically in office workers . According to the Global Burden of Disease 2015, neck pain remain the leading cause of years lived with disability (YLD) and the fourth leading cause of disability-adjusted life years (DALYs).Besides a large population of male and female patients are attended in OPD of Mahesh Bhattacharyya homoeopathic medical college and hospital daily with high prevalence of CS in adult age group. So, it will be an ideal set up to conduct the study.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Patients of age group of 18-60 years.
  • Positive radiological findings for cervical spondylosis.
  • Patients willing to give consent.

排除标准

  • Co-morbid conditions like uncontrolled endocrine disorder, inflammatory rheumatic disorder or other life threatening illness affecting quality of life.
  • Neurological Diseases like Alzheimer disease, dementia.
  • Pregnant and lactating women.
  • Undergoing Homoeopathic treatment for any other Clinical condition.

结局指标

主要结局

To understand the impact on pain by using Numeric Pain Rating Scale.

时间窗: Each Patients will be assessed at the baseline( before start of the treatment i.e. 0 weeks) and three months( 12 weeks after the start of treatment) after intervention

次要结局

  • To understand the imapct on quality of life by EQ-5D-5L questionnaires.(Each Patients will be assessed at the baseline(before the start of treatment i.e. 0 weeks) & three months( after 12 weeks) after intervention)

研究者

发起方
Mahesh Bhattacharyya Homoeopathic Medical College And Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Piu Mondal

Mahesh Bhattacharyya Homoeopathic Medical College and Hospital

研究点 (1)

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