A Non-Randomised Clinical Trial to Evaluate the Efficacy of Uttarbhaktika Snehana and Manya Basti in the Management of Cervical Radiculopathy
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1.To assess the effect of Uttarbhaktika Snehana with Rasna Ghrita in the patients of Cervical Radiculopathy.
研究概览
简要总结
Cervicalradiculopathy is a neurologic condition characterized by dysfunction of acervical spinal nerve, the roots of the nerve, or both. It usually presentswith pain in the neck and one arm, with a combination of sensory loss, loss ofmotor function, or reflex changes in the affected nerve-root distribution. Thesymptoms includeneck pain, radiation of pain, stiffness, weakness, paresthesia,clumsy finger movements, vertigo, tenderness over cervical, movements of theneck restricted etc. It is commonly called a "pinched nerve,"occurs when a nerve in the neck is compressed or irritated where it branchesaway from the spinal cord. It is often caused by "wear and tear"changes that occur in the spine. Because of present-day lifestyles, food,habits, excessive stress-strain and anxiety more people are getting theseproblems. In younger people, it is most often caused by a sudden injury thatresults in a herniated disk. In some cases, however, there is no traumaticepisode associated with the onset of symptoms. It is associated with movementimpairment of the upper limbs in 68% of the cases, scapular pain in 52.5% ofcases, paresthesia in 45.5% of the cases, chest pain in 17.8% of the cases andheadache in 9.7% of the cases, among others.
It is a commondisease affecting the middle and old age group of both sex and is prevalentworldwide with a lifetime incidence of 40-60%. The most affected age group is30-70 years.In daily wage labourers and some occupational postureslike in teachers, coolies, drivers, tailors are the commonest causes of neckpain. In males the prevalence is 100% by age 70yrs, 96% in women older than 70yrs. 60-70% women and 85% of men show changes related with cervical spondylosisby the age of 45yrs.
Viswachiis a disease which exhibits weakness or sensational disturbances, disturbancesof the movements of the hand. Vishwachi is a disease affecting the neck andupper extremities having the signs and symptoms like Ruka, Stambha, Toda,Karmakshaya and Chestapaharana of Bahu.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Those who are diagnosed with the features of cervical herniated disc or bone spur is impeding a nerve root in the neck through MRI finding with a feature like difficulty in movements of the arm, stiffness in hand, clumsy movements of fingers, neck pain, radiation of pain, stiffness, weakness, paresthesia, vertigo, tenderness over cervical, movements of the neck restricted.
- •Patients with age group of 18-55 years.
- •Willing and able to participate in the study for 1 month.
排除标准
- •Those who are not willing to participate in the study.
- •Pregnancy and Lactating mother.
- •History of cervical instability, cord compression, central pain syndrome (e.
- •Fibromyalgia), evidence of CNS involvement, known history of high- level spinal cord injury, traumatic injuries to upper limb and cervical spine, limitation of glenohumeral joint, elbow joint or wrist joint, evidence of malignancy.
- •Any medical red flag.
- •(i.e., spinal tumor, fracture, metabolic disease, RA, osteoporosis, spinal infection etc).
- •Patients having co – morbidities like hypertension (systolic >160 and diastolic >100 mm of Hg) despite of antihypertensive agents and diabetic mellitus (According to WHO, fasting plasma glucose ≥ 7.0mmol/l (126mg/dl) or 2–h plasma glucose ≥ 11.1mmol/l (200mg/dl), active case of tuberculosis.
- •Those who have completed participation in any other clinical trial drugs or their ingredients in one -month period.
结局指标
主要结局
1.To assess the effect of Uttarbhaktika Snehana with Rasna Ghrita in the patients of Cervical Radiculopathy.
时间窗: Check the efficacy of Uttarbhaktika Snehana and Manya Basti with the help of neck disability index, foraminal compression (Spurling’s test), distraction test, upper limb tension test (brachial plexus tension or Elvey test), cervical rotation test | [time frame:baseline or 0th day, 8th and 16th and 30th day]
2. To compare the efficacy of Uttarbhaktika Snehana and Manya Basti with the help of neck disability index, foraminal compression (Spurling’s test), distraction test, upper limb tension test (brachial plexus tension or Elvey test), cervical rotation test.
时间窗: Check the efficacy of Uttarbhaktika Snehana and Manya Basti with the help of neck disability index, foraminal compression (Spurling’s test), distraction test, upper limb tension test (brachial plexus tension or Elvey test), cervical rotation test | [time frame:baseline or 0th day, 8th and 16th and 30th day]
3. To provide comparative analysis of effect of Uttarbhaktika Snehana and Manya Basti in Cervical Radiculopathy.
时间窗: Check the efficacy of Uttarbhaktika Snehana and Manya Basti with the help of neck disability index, foraminal compression (Spurling’s test), distraction test, upper limb tension test (brachial plexus tension or Elvey test), cervical rotation test | [time frame:baseline or 0th day, 8th and 16th and 30th day]
次要结局
- 1.Evaluate the therapeutic efficacy of Uttarbhaktika Snehana.(2.Evaluate the therapeutic efficacy of Manya Basti.)