CTRI/2023/05/052859尚未招募3 期
â??A randomized controlled clinical trial to evaluate the efficacy of Ayurveda treatment protocol in lumbar disc herniation with radiculopathyâ??
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES Ministry of AYUSH, Government of India0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Participants of any gender in the age group 25-55 years.
- •2.Subjects having Oswestry disability index (ODI) score between 21% -60 %.
- •3.Participants diagnosed with lumbar disc herniation with radiculopathy with unilateral radiating pain (either left or right lower limb) due to Intervertebral disc herniation confirmed by MRI (disc herniation between L3 and S1 level; at single or double level) provided no neurologic deficit is evident
- •4.Positive straight leg raise test (ipsilateral or contralateral pain in the leg, buttock, or back at 70 degrees or less of leg elevation, and the pain is typically worsened by dorsiflexion of ankle or neck flexion after slowly lowering the leg until the patient no longer feels pain
- •5.Willingness to provide informed consent and adhere to the study protocol for 2 months.
排除标准
- •1.Indication for surgical intervention for disc herniation like severe motor deficit (motor power of lower limbs assessed through Medical Research Council Manual Muscle Testing scale <=3), severe spinal stenosis; excruciating pain that cannot be managed by conservative treatment, foraminal stenosis, conjoint nerve root, perineural cyst etc.
- •2.Patients who have received non pharmacological interventions like physiotherapy, traction, manual therapy, etc. for the management of lumbar disc herniation in last 3 months.
- •3.History of or evidence of any of the following - Osteoporotic lumbar fracture, presence of inflammatory or infective diseases that affect spinal morphology, such as ankylosing spondylitis, Spondylodiscitis or inflammatory spondylitis, spondylolisthesis, Pottâ??s spine, Pyriformis syndrome, sacro-iliitis, neural foraminal stenosis
- •4. History of spinal surgery in last 2 years or having epidural fibrosis.
- •5.Patients with caudaequina syndrome or neurological deficits such as foot drop, limb muscle wasting and bowel/bladder incontinence or Non-ambulatory patients with Monoplegia/ Paraplegia/ Hemiplegia.
- •6.Evidence or history of spinal trauma or Spinal Malignancy.
- •7.Presence of other medical condition presenting with numbness and pain in lower extremities, such as diabetic polyneuropathy and peripheral vascular disease, Motor Neuron Disease, Multiple Sclerosis, Stroke or Cognitive Impairment.
- •8.Major coexisting medical condition such as cancer, chronic obstructive pulmonary disease, cardiovascular disease and severe hepatic and renal dysfunction.
- •9.Peptic ulcer disease, GI haemorrhage/perforation.
- •10.Obesity (BMI greater than or equal to 30 kg/m2).
- •11.Metallic implants like pace makers, hearing aid implants etc. and other contraindications for MRI.
- •12.Any other condition that as per the investigator is contraindicated for the intervention in the study.
研究者
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