Health Condition 1: null- Low back pain radiating to one or both lower extremities
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex within the age between 18-65 years. 2. Low back pain radiating to one or both lower extremities (buttock and below) of >3 months but equal or less than 2 years duration. 3. Patient testing positive for Straight Leg Raising (SLR), Lasegueâ??s sign 4. Patients with a pain level of equal or greater than 2 on a scale of 0-10 (VAS) 5. MRI evidence of a herniated disc spine corresponding to the patientâ??s radicular symptoms. 6. Willing to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Tuberculosis of the spine / hip. 2. Ankylosing spondylosis or Fractures or secondary to fractures 3. Patients with neurological deficits like, sensory loss, foot drop, limb muscle wasting and bowel/bladder incontinence 4. Patients diagnosed as diabetes mellitus (HbA1c > 6.5 %, FBS >126 mg/dl) and complications of Diabetes Mellitus viz., neuropathy, nephropathy, retinopathy, etc. 5. Patients who have a known history of cardiovascular diseases. 6. Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT >3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2 mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease. 7. Inflammatory Bowel Disease, Severe Dementia, Severe Infection(s), Non-ambulatory patients Monoplegia / Paraplegia/hemiplegia. 8. Pregnant / Lactating women. 9. Patients with evidence of malignancy 10. Psychiatric diseases, Alcoholics and/or substance abusers 11. Patients who have completed participation in any other clinical trial during the past six (06) months. 12. Any other condition which the Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Improvement in the Straight Leg Raising test â?? SLR/Lasegueâ??s sign 2. Change in the visual analogue scale (VAS) for pain in last 48 hours 3. Change in disease specific Ayurvedic parameters 4. Change in severity of disease symptoms 5. Rolandâ??Morris disability questionnaire (RDQ-23) for low back ache and sciatica Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement in MRI 2. Coin Test 3. Lumbar spine mobility test (LSM) 4. Femoral Nerve Strech Test (FNS) 5. Change in laboratory parameters and X-Ray Timepoint: 12 weeks | — |
Countries
India
Contacts
Regional Ayurveda Research Institute for Metabolic Disorders