An open single arm clinical trial to determine the effectiveness of Uloga Suttigai (Metal Cauterization) in the management of Vathathambam (Sciatica)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The therapeutic effectiveness of Uloga suttigai for the management of sciatic pain will be determined by visual analogue scale and Oswestry low back disability index
研究概览
简要总结
BACKGROUND
The Siddha system of medicine is based on a combination of ancient medical practices and spiritual disciplines In the text Yugi vaythiya chinthamani Yugimunivar classified the Vadha disease as 80 types and Vadathambam is one among them.In modern medicine Vathathambam may be correlated with Sciatica Sciatica pain is the most common musculo skeletal conditions that have life time prevalence of up to 70 percentage and this seems to be increasing in incidences Sciatica is condition in which the patient experience pain and or paresthesias in the sciatic nerve distribution or an associated lumbo sacral nerve root the sciatic nerve is made up of the L4 through S2 nerve roots which coalesce at the pelvis to form the sciatic nerve At upto 2cm in diameter the sciatic nerve is easily largest nerve in the body Sciatic pain often is worsened with flexion of the lumbar spine twisting bending or coughing The sciatic nerve provides direct motor function to the hamstrings lower extremity adductors and indirect motor function to the calf muscle anterior lower leg muscle and some intrinsic foot muscles Also indirectly through its terminal branches the sciatic nerve provides sensation to the posterior and lateral lower leg and the plantar aspect of the foot The straight leg raise test is a passive examination Typically pain that is reproduced between 30 to 70 degrees of hip flexion and experienced primarily in the back is likely due to a lumbar disc herniation In modern medicine the condition is managed by electro therapy hydrotherapy and exercise therapy to the patients Suttigai is one of the 32 external medicines found in Siddha literatures under the topic Puramarunthugal Vathathambam is caused by vitiated Vatham In chronic condition Kabam also added with vitiated Vatham and produce severe symptoms and signs In Suttigai procedure is mostly used in chronic and severe symptoms This Suttigai procedure act over cutaneous receptor and first cause sharp pain through ascending pathway and activate the descending pathway endogenous analgesic system Periaqueductal grey matter PAGdorsal raphe nucleus nucleus raphe Magnus and medial reticular column which involves the various chemicals
Suttigai therapy is non pharmocological cost effective economically non viable easy to perform even at remote areas for management of sciatica
OBJECTIVE
To study the therapeutic effectiveness of Uloga Suttigai (Metal cauterization) in reducing the clinical signs and symptoms of Vathathambam (Sciatica) through VAS scale and Oswestry low back Disability Index
STUDY DESIGN
An open single arm clinical trial with a total number of 30 diagnosed patient of Vathathambam Sciatica reporting at Ayothidoss Pandithar hospital National Institute of Siddha will be enrolled in the study patients having history of uncontrolled Diabetes Rheumatoid arthritis Chronic alcoholism Psychiatric illness Limb weakness Foot drop fracture infective arthiritis Pregnant and Lactating women will excluded The trial procedure suttigai will be given for 48 days
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
- 20.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •1 Presence of low back pain 2 Presence of burning pain numbness paresthesia and tingling sensation 3 A positive SLR test 4 Willing to give blood samples for investigation 5 Willing to take photographs 6 Willing to participate in trial and signing consent by fulfilling the condition of proforma.
排除标准
- •Known history infective arthritis Known history of fracture of malunion History of uncontrolled diabetes mellitus Pregnant and lactating women Known case of limb weakness and foot drop Chronic alcoholism Psychiatric illness Rheumatoid arthritis.
结局指标
主要结局
The therapeutic effectiveness of Uloga suttigai for the management of sciatic pain will be determined by visual analogue scale and Oswestry low back disability index
时间窗: 48 days
次要结局
未报告次要终点
研究者
N A Adlinnivetha
National Institute of Siddha
