INTRODUCTION

PURPOSE OF THE STUDY 

Sciatica is classified in ICD 11-MMS as diagnostic code as ME84.3 Sciatica defined as a radiating pain along the course of the sciatic nerve and is felt in the back, buttocks, posterior of the thigh, legs and the foot.Sciatica are also termed as Ischialgia , Neuralgia or Neuritis of Sciatic nerve Sciatic neuralgia, Sciatic nerve neuritis. Sciatica can result from a herniated disc pressing directly on the nerve. Any cause of irritation or inflammation of this nerve can reproduce the painful symptoms of sciatica. The sciatica pain greatly interfere with an individual’s ability to perform daily activates. It may lead to reduce productivity and reduce quality of life.If proper treatment was not given to patient, who is suffering to sciatica it may lead to complications. With time the intensity of pain and parenthesis may be increase in the affected leg leads to loss of muscle strength in affected legs, loss of bladder and bowel control, and at last may be permanent damage to sciatica nerve may occur

EPIDEMIOLOGY Recent modification of lifestyle, some stress factors and some occupational factors like IT professional, teaches, driver, security guards are responsible for increase in incidence rate of sciatica. Physical activity associated with occupation has also been shown to influence incidence of sciatica. Carpenters and machine operators were shown to be more likely to develop sciatica than sedentary office workers. 

KNOWLEDGE GAP In modern medications such as Analgesics such as acetaminophen and tramadol, can relieve pain. Long-term use of analgesics and NSAID’S may cause stomach ulcers as well as kidney and liver problems . Homoeopathy with its scientific holistic approach helps understanding the individual who is suffering from Sciatica. Thus offering relief in most gentle and comprehensive way. Physician has to study all the causative factors in a given case he cannot be satisfied merely by paying attention to those factors commonly held to be responsible for the disease. This is more so, as he has to be sure that all impediments to cure have been removed before he proceeds with the administration of the similar remedy. There are many medicines in our Materia Medica , some of these remedies have significant action on nerves thus clinical presentation corresponds to symptoms arising due to irritation of nerves i.e. the neuralgia with extreme hypersensitivity. So Homoeopathic remedies are best suited in sciatica without any significant side effects due to minuteness of dose. The selection of remedy based upon the theory of individualization and characteristic symptoms of the individual in every case.This study bridges the gap by assessing the impact of effectiveness of individualised Homoeopathic medicine in management of Sciatica among adults. Hence the study will be undertaken to understand the effectiveness of individualised homoeopathic medicines in management of Sciatica among adults.

OBJECTIVES

 PRIMARY OBJECTIVE To assess effectiveness of the individualised Homoeopathic Medicines in the management of sciatica among adults.

SECONDARY OBJECTIVE 1 To compare the patient pre- treatment and post treatment score for Sciatica on VAS scale and Modified Roland Sciatica Questionnaire.

 SECONDARY OBJECTIVE 2 To arrive at a group of remedies (Homoeopathic medicines) indicated in the management of Sciatica among adults

METHODOLOGY

STUDY DESIGN An Experimental Non Controlled study

STUDY SETTING Cases of Sciatica will be recruited from Out Patient department of the institute.

DURATION OF STUDY

1.       Duration of study : 18 months

2.       Duration of each case: Each case will be studied for 8 months or till       relief of symptoms.

3.       Duration of follow up: Each case will be followed up after 15 days or as and when required.

4.       Clinical Outcome Assessment will be done at base, 1 month,

5.       3 month, 6 months and at termination of treatment

METHOD OF SELECTION OF STUDY SUBJECT (ELIGIBILITY CRITERIA)

INCLUSION CRITERIA

1.       Clinically diagnosed cases of sciatica.

2.       Patients of adult age group.

3.       Patients belonging to all gender.

4.       Patients willing to give informed written consent.

EXCLUSION CRITERIA

1.       Patient who advised for surgical interventions like Cauda Equina Syndrome or       Progressive Large Paresis .

2.       Patients having any Surgical history of spine.

3.       Spinal or Intraspinal tumors.

4.       Traumatic conditions, Infection and Fracture of Spine.

5.       Non-adherence to treatment protocols.

6.       Suspected Immuno-compromised patients.

7.       Pregnant and Lactating women.

    SUBJECT WITHDRAWAL CRITERIA:

1.       Patients not coming for follow up regularly.

2.       Patients who are not taking their prescribed medications timely.

3.       Patients who withdrew their consent.

4.       Patients who started taking other medications and physiotherapy in between the treatment.

METHOD OF SELECTION OF COMPARISION OR CONTROL :Not Applicable

           MATCHING CRITERIA : Not Applicable

 OPERATIONAL DEFINITION

Sciatica is classified in ICD 11-MMS as diagnostic code as ME84.3Sciatica defined as Neuralgic pain radiating down the back to the Buttock, thigh, calf, and foot with or without Numbness and Weakness of Lower Limb. The most important symptom of sciatica is lumbosacral radicular leg pain that follows a dermatomal pattern radiating below the knee and into the foot and toes. The pain worsens with coughing; patients may report sensory symptoms, limited forward flexion of the lumbar spine, gait deformity and unilateral spasm of the paraspinal muscles .INDIVIDUALISED HOMOEOPATHIC MEDICINE §153 “In this search for a homoeopathic specific remedy, that is to say, in this comparison of the collective symptoms of the natural disease with the list of symptoms of known medicines, in order to find among these an artificial morbific agent corresponding by similarity to the disease to be cured, the more striking, singular, uncommon and peculiar (characteristic) signs and symptom of the case of disease are chiefly and most solely to be kept in view; for it is more particularly these that very similar ones in the list of symptoms of the selected medicine must correspond to, in order to constitute it the most suitable for effecting the cure. The more general and undefined symptoms: loss of appetite, headache, debility, restless sleep, discomfort, and so forth, demand but little attention when of that vague and indefinite character, if they cannot be more accurately described, as symptoms of such a general nature are observed in almost every disease and from almost every drug.

SPECIFICATIONS OF INSTRUMENTS & RELATED MEASUREMENTS

1.      Standard homoeopathic case taking proforma will be used in each case.

2.      Outcome assessment tool:

a.      Pre validated Visual Analogue scale

b.      Modified Roland Sciatica Questionnaire

Pre- validated Visual Analogue Scale (VAS): A common method to assess pain intensity is using a Visual Analogue Scale (VAS), a 10- point scale where 0 represents no pain and 10 represent the worst possible pain.             

Pain Intensity Categories:

a.      Mild: Scores of 1-3.

b.      Moderate: Scores of 4-6

c.       Severe: Scores of 7-10

Modified Roland Sciatica Questionnaire

        The score is calculated by adding up the number of statements checked; possible scores range from 0 (no disability) to 23 (maximum disability)

 Score     0 to 4      Minimal or No disability

                  5 to 10     Mild Disability

                  11 to 17    Moderate Disability

                   18 to 23  Severe Disability

 The Outcome will be assessed in term of

  Clinical Outcome

1.       Intensity of pain of Sciatica

2.        Improvement of the patient will be assessed as a whole on the basis of Physical general symptoms and Mental state.

         Statistical Outcome:

As per comparison of the pre-treatment and post treatment scores in cases of Sciatica on “VAS scale” & “Modified Roland Sciatica Questionnaire”

   Assessment Outcome:

1.       Improved  VAS scale score & Modified Roland Sciatica Questionnaire score is reduced than the previous score , after taking Homoeopathic Medicines.

2.       Non Improved VAS scale score & Modified Roland Sciatica Questionnaire score remains same after taking Homoeopathic Medicines.

IMPROVED  A Score 0 - 4 : Minimal or No disability

NOT IMPROVED  Score 5 - 10 : Mild Disability

Score 11 - 17 :Moderate Disability

Score 18 -23 :Severe Disability

RESEARCH METHODOLOGY & DATA COLLECTION

       SAMPLE SIZE Total sample size is 45

      SAMPLING TECHNIQUE Non Probability Purposive Sampling Technique

      METHOD OF DATA COLLECTION RELEVENT TO OBJECTIVES

1.         Non Probability Purposive Sampling Technique.

2.       Informed written consent of 45 patients clinically diagnosed with Sciatica will be recruited from outpatient department of the institute and their cases will be recorded.

3.       Detailed Homoeopathic case taking will be done as per the Proforma for collecting and analysing data prepared to arrive at individualised homoeopathic medicine.

4.       Depending on the clinical presentation of the patient and totality erected, the patient will be administered indicated individualised homoeopathic medicine.

5.       Posology will be selected as per the requirement of the case.

STUDY INSTRUMENTS / DATA COLLECTION TOOLS

1.       Informed written consent will be taken.

2.       Complete Homoeopathic Case taking proforma.

3.       Visual Analogue Scale (VAS) and Modified Roland Sciatica questionnaires will be used to assess the severity of symptoms before and after the treatment.

4.       Appropriate reference books like Homoeopathic Materia Medica, Medicine books, Organon books, Pathology books, different homoeopathic journals and research papers will be considered.

5.       Appropriate Software will be used for repertorization of case.

DATA MANAGEMENT AND ANALYSIS PROCEDURE

1.        Framing of totality of symptoms will be done as per principles of Homoeopathy.

2.       Selection of remedy Homoeopathic remedies will be given as and when required after referring Materia medica.

3.       The Posology: Appropriate potency for each case will be selected based on the susceptibility of each patient. Potency will be modified as and when required.

4.       Duration of Study

a.  Duration of study : 18 months

b.  Duration of each case: Each case will be studied for 8 months or till relief of symptoms.

c.  Duration of follow up: Each case will be followed up after 15 days or as and when required.

d.  Clinical Outcome Assessment will be done at baseline, 1 month, 3 month, 6 months and at termination of treatment.

PLAN FOR STATISTICAL ANALYSIS

1.      Data collected will be compiled on MS Office Excel Sheet and will be subjected to statistical analysis using an appropriate software like SPSS(Statistical Package for Social Sciences). Descriptive statistics like frequency (n) & percentage (%) of categorical data, mean & standard deviation of numerical data in each time interval will be depicted.

2.      Normality of numerical data will be checked using Shapiro– Wilk test or Kolmogorov-Smirnov test. Depending on the normality of data, statistical tests will be determined.