A Randomized Controlled Trial to Assess the Efficacy of Siravedha and Distal Sodium Channel Block in the Management of Grudhrasi w.s.r Sciatica
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- •Change in VAS, MRSS Score , SLR &Buckling test.
Study Overview
Brief Summary
In Ayurveda Grudhrasi is a type of Vatvyadhi characterized by the clinical features of radiating pain from Spikha (gluteal region) to Pada (foot). Vata and Kapha are predominantly involved dosha in this disease and pain is the cardinal symptom.[i] Based on the symptomatology of Ghrudhrasi it can be corelated with the disease Sciatica in modern parlance.Sciatica occurs due to spinal nerve irritation and is characterized by pain in distribution of sciatica nerve manifesting into chronic radiating low back pain to lower limbs
Distal Sodium Channel Block (DSCB) is a newer concept of pain management which is now being widely practiced. Infiltration of local anesthetic drugs singly or in combination with those that augment or prolong its action around the nerve sheaths, at the most terminal branch along its course
Primary Objective:
• To assess & compare the efficacy of Siravedha and DSCB in the management of Sciatica.
Secondary Objectives:
• To assess the outcome of Siravedha and DSCB.
• To assess the patient’s quality of life .(SF-12 Questionnaire)
Patients attending the OPD/IPD of the PG Department of Shalya Tantra, NIA hospital will be selected who will be fulfilling the criteria of inclusion, details of the study will be explained, and informed written consent of each patient will be taken on prescribed proforma. After that clinical trial will be executed
Total 40 patients will be selected after detail examination and divided in 2 groups of 20 patients each as per study protocol. All Procedures will be executed done under aseptic condition.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 25.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age: Patients of either gender between 25-60 years.
- •Patient having typical clinical feature pertaining to the Sciatica like Constant aching pain felt in the lumbar region and may radiate to the buttock, thigh, calf and foot.
- •Diagnosed case of Sciatica through Positive Passive SLRT and Buckling test .
- •Patients having normal CT, BT and Hb above 10gm percent will undergo Siravedha Patient willing to undergo trial.
Exclusion Criteria
- ••Patients with infectious diseases of spine.
- ••Patient with infection at the site of DSCB infiltration and Siravedha.
- ••Patients with past history of or ongoing malignancy or chemotherapy or radiotherapy •Patients with uncontrolled Diabetes mellitus, Cardiovascular diseases, HIV,Hypertension •Pregnant or Lactating Females.
- ••Patients with known hypersensitivity.
Outcomes
Primary Outcomes
•Change in VAS, MRSS Score , SLR &Buckling test.
Time Frame: BASELINE And 57 Days
•Improvement in symptoms of Sciatica.
Time Frame: BASELINE And 57 Days
Secondary Outcomes
- Change in the quality of life of the patient.( as per SF-12 Questionnaire).(BASELINE And 57 Days)