1.    INTRODUCTION

In the modern era, the individual’s faulty lifestyle in terms of aahara and vihara and nature of predisposing stress and long working hours are adding tension on the usual health causing one of the dreadful and day to day life hampering condition called as sciatica (gridhrasi). Due to this Gridhrasi is one of the most frequently encountered intractable physical complaint which affects the ambulatory functions of the patient. The patient is unable to carry out day to day life due to excruciating pain, limiting to inability of body movements.

The word Gridhrasi itself suggest the limping gait similar to Vulture. The disease has been mentioned and counted among one of the 80 nanatmaja vata vikaras and explanation been given in the vatavyadhi, occurring due to vitiation of the vata and sometimes kapha dosha. The cardinal symptoms of Gridhrasi are Stambha (stiffness), Ruka (pain), Toda (pricking pain) and Muhuspandanam (twitching) in sphika, kati, uru, janu, jangha, pada in order. In kaphanubandata, Tandra, Gaurava, Arochaka are observed. The treatment modalities been told in ayurveda ranging from shamana to shodhana, out of those all treaties Siravedha is also among treatment plan for this disease postulated by acharya Susruta.

A similar condition in modern science is Sciatica.

Sciatica (or sciatic neuritis) is a set of symptoms including pain (broadly dealt under the term lower back ache) that may be caused by general compression and/or irritation of one of the five spinal nerve roots of sciatic nerve. It is a painful condition in which pain commences from the lower back or buttock and radiates to the lower extremity along its posterior or lateral aspect, more or less comprising of the area of distribution of the sciatic nerve. In addition to pain and radiation to the thighs, there may be numbness, muscular weakness, tingling sensation and difficulty in moving or controlling the leg, and the severity may be addressed by the altered gait.

The lifetime incidences of the disease varies from the range 10% to 40% while the annual incidenceⁱ varies from 1% to 6%. And the incidences rate varied from range less than 1% to 37%. In a statistical study on the epidemiology review on sciatica states the prevalence from 1.2% to 43%. The major affected age group under data came out to be the young adults (18 to 40 years) and the adults (41 to 60 years).

With wide range of clinical assessment of the range of motions to different maneuver, the treatment of the sciatica is still a challenge for the modern medicine and surgery. The treatment option for sciatica in present times includes: conservative treatment, epidural steroid injection, peri-radicular infiltration and lastly surgical intervention, which may leads to very severe post- surgery complications.

All these treatment options have their own side effects and complications, the cure is not certain and there is possibility of recurrence .The main emphasis of the interventions done to patients is just to maintain and improve the qualityⁱⁱ of life of the patient.

2.Lacunae in existing knowledge

Pre-existing work done in form of siravedha in gridhrasi comprises of 4angula above the knee joint; and that was without site specification. And the unexplored part mention in Susruta Samhita, siravedha    4angula below knee joint is yet to be established. So site assessment with effectiveness of either above or below knee joint criteria will refresh the knowledge and add on the clinical utility of the sidhanta of siravedha in terms of vedhya and avedhya siras are mentioned in Susruta Samhita. Also, the work on disease has been a part of research in the streamline of the Panchkarma, Kayachikitsa, Shalya and Rachana sharir yet no upfront work on this dreadful disease was contained.

2.1. Future Scope of Study

The study will provide futuristic base for site assessment to researchers who want to take this study further to next level, in attempt to alleviate this dreadful disease.

3. Research question

Whether above knee siravedha is more, less or equally effective than below knee siravedha in the management of gridhrasi?

1.    Hypothesis

Null Hypothesis : (H0):

There is statistically no significant difference in the effectiveness of siravedha in above or below the knee joint.

Alternate Hypothesis:

(H1): There is statistically significant difference in the effectiveness of siravedha - above than below the knee joint.

(H2): There is statistically significant difference in the effectiveness of siravedha - below than above the knee joint.

5. Review of literature :

6. Previous works:

1. A Comparative Clinical Evaluation of Agnikarma and Raktamokshana in Management of Gridhrasi (Sciatica).- by Durgesh Nandini, Tukaram Sambhaji Dudhamal - Dept. of Shalya Tantra, Institute for Post Graduate Teaching and Research In Ayurveda, Jamnagar.

2. Clinical Evaluation of Siravedha In The Management Of Gridhrasi  w.s.r to Sciatica-by Dr. Jitender Kumar Rana-Dept. of Shalya Tantra, Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre, Shobhit University, Gangoh

3.Clinical Effect of Siravedha at Dakshin Kurpura Sandhi in the Management of Non Alcoholic Fatty Liver Disease-by Dr. Gaurav Sawarkar, Dept. of Rachana Sharir, Mahatma Gandhi Ayurveda College, Wardha

4. Various clinical Considerations of Sira: Anatomical considerations, Sira vedhan And Sira Gata Vata- by Dr. Avinash Babanrao Chavan, Dept. of Rachana Sharir, S.GR Ayurveda College, Solapur.

5. Pilot Study to Test Efficacy of Siravedha in Non-Alcoholic Fatty Liver Disease-by Dr. Gaurav Sawarkar, Dr. Punam Sawarkar, Dr. Priti Desai, Dr. Madhulika Tiwari - Dept. of Rachana Sharir & Panchkarma, Mahatma Gandhi Ayurved College, Wardha.

6. Effect of Siravedha in Varicose Vein-an Exploratory Data Analysis and Modelling-by Dr. Jayashree R K artha, Dr. Abhilash M, Dr. Umesh P. Dr. Ajitha K-Dept. of Kriya Sharir, PNNM Ayurveda Medical College and Hospital, Thrissur.

7. Aim and Objective

7.1) Aim: To assess the exact anatomical site of siravedha-above and below the knee joint in management of Gridhrasi (Sciatica).

7.2] Objectives:

Primary Objective

·       To assess the preferred anatomical sites for siravedha above and below the knee joint.

·       To assess the more effective anatomical site of siravedha .

Secondary Objective

To assess the pain assessment criteria.

·       Visual analogue scale (VAS) for pain intensity (annexure 1-2).

·       Gradation of cardinal parameters^xvi (annexure 1-3)

8. Material and Methods

8.1] Source of Data:

Literary Source: All the Ayurvedic, modern literatures and contemporary texts including the journals, websites were reviewed and documented about the disease and parasurgical part for the intended study

Clinical Source: Patients of Gridhrasi (Sciatica) will be selected from ShalyaTantra OPD and IPD of Chaudhary Brahma Prakash Ayurved Charaka Sansthan, Najafgarh , Delhi-73.

8.2] Type of Study: Interventional study (CLINICAL STUDY)

8.3] Study Design: Randomized clinical trial

·       Single centered 

·       Allocation: Randomized (computer generated)

·       Type: Simple randomization

·       Intervention model: Parallel

·       Masking: None (Open Label)

·       Comparative study

Statistical Design – A comprehensive statistical analysis will be performed to evalute the efficacy of the interventions by comparing the twi groups. After the completion of trial, data will be collected and subjected to statistical analysis to determine the significance of the result.

1- Student t test - used to test whether the difference between the response of two groups is statistically sigificant or not.

8.4] Sampling Procedure

Study setting: Single centered (O.P.D./LP.D. in Ch. Brahm Prakash Ayurveda Charak Sansthan, Khera Dabar, New Delhi)

Case Definition: Patient will be diagnosed based on classical features of Gridhrasi mentioned in texts such as Stambha (stiffness), Ruka (pain), Toda (pricking pain) and Mukuspandanam (twitching) in sphika, kati, uru, janu, jangha, pada in order. In kaphanubandata, Tandra, Gaurava, Arochaka 

Sample Size: Type of the study: RCT of Two independent groups.

Type of Outcome variable: Continuous

Sample Size of 20 i.e. 10 in each group .

Sample Size Calculation –

The sample size was determined using an online calculator provided by OpenEpi.com, which utilized the following formula and assumptions

Study design: Randomized Controlled Trial (RCT) comparing two independent groups.

Sample size formula are used as follows –

n1= (σ2 1+ σ2 2/k) (z1- α/2+z1-β)2/   2

the notation for the formulae is :

n1 = sample size of Group 1

n2 = sample size of Group 2

σ 1 = standard deviation of Group 1

σ 2 = standard deviation of Group 2

     = difference in group means

k = ratio = n2/n1

Z1-a/2 = two-sided Z value (e.g. Z=1.96 for 95% confidence interval).

Z1-ẞ = power

Confidence interval - 95%

Power - 80%

Alpha: 0.05,

Beta: 0.2,

Power-0.8

Ratio of sample size (group 2/ group 1) - 1

 Mean of Group 1- 12.4

 Standard deviation of Group 1-16.2

Assumed Mean of Group 2- 38.34

Assumed Standard deviation of Group 2 -24.23

On applying the values on Open epi calculator, Sample size (n) = 10 in each group

Reference to this was previous study with title Effect and neurophysiological mechanism

of acupuncture in patients with chronic sciatica: protocol for a randomized, patient-

assessor blind, sham-controlled clinical trial

8.5] Standard Operating Procedures:

8.5.1] Indications:

^o     As prophylaxis-diseases of skin, tumor, oedema and diseases arising from blood will never occur in persons treated with Raktamokshan .(Su.Su. 14/34)^xvii

o   Diseases which cannot be treated by cold or hot treatments.

o   Benign tumors

o   Glandular swellings

o   Epilepsy

o   Insanity

o   Abscesses

o   Dysentery

o   Sciatica

o   Burning sensation in soles

o   Rheumatoid Disease

8.5.2]Contraindications:

o   Excessive sudation

o   Pregnant women, or in puerperium

o   Indigestion

o   Bleeding disorders

o   Diarrhea, vomiting

o   Anemia

o   Anasarca

o   Ascites

8.5.3] Contraindicated Veins:

o   Invisible veins.

o   Visible but inaccessible.

o   Collapsed veins.

8.5.4] Site used for siravedha in previous study

(a) A comparative Clinical Evaluation of Agnikarma and Raktamokshana in Management of Gridhrasi (Sciatica).- by Durgesh Nandini, Tukaram Sambhaji Dudhamal - Dept. of Shalya Tantra, Institute for Post Graduate Teaching and Research In Ayurveda, Jamnagar.

Site used for siravedha in this study – four angula above knee joint

(b)  Clinical Evaluation of Siravedha In The Management Of Gridhrasi  w.s.r to Sciatica-by Dr. Jitender Kumar Rana-Dept. of Shalya Tantra, Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre, Shobhit University, Gangoh.

Site used for siravedha in this study – four angula below knee joint

8.5.5] Season for the siravedha:

o   Anushna-sheeta kaal must be preferred.

o   Extreme cold-bleeding not proper (patient subjected

to swedana in closed chamber and local fomentation also applied).

o   Extreme hot-excessive bleeding (cooling measures adopted).

8.5.6] Materials required:

o   Scalp vein set (20 G)/disposable syringe (24 G)

o   Measuring glass beaker

o   Sterile Cotton & pads

o   Bandage

o   Tourniquet

o   Sterile Gloves

o   Aloe vera gel

8.5.7] Pre-procedure:

o   A detailed proforma sheet and Informed consent will be annexed.

o   Investigations needed - Hb gm%, B.T., C.T., RBS, HIV I & II, Anti HCV &

HBsAg .

o   Tetanus prophylaxis 0.5ml IM, to be done.

o   Explain procedure/pre-counselling to the patient.

o   Vitals recording.

8.5.8] Procedure:

o   Part preparation with aloe vera.

o   Patient is made to sit and extremity must be hanging down.

o   A tourniquet applied to make the vein prominent. (it should be applied 3-4 inches above the site of lesion.)

o   Prick by 24 G NEEDLE OR SCALP VEIN SET (20G).

o   Needle (Vrihi mukha sastra) must be inserted quickly neither too deep nor superficial without injuring the marma points.

o   Blood comes out in the form of stream and it stops by its own. [40-50 ml of blood to be let out]

o   Collection in Measuring Glass Beaker for assessment of evacuated blood

o   Process must be continued till bleeding stops by itself or Samyak siravedha lashanas appear .

8.5.9] Post-procedure:

o   Tourniquet should be released slowly.

o   Needle will be taken out and wound dressed with Turmeric powder.

o   Limb is to be kept elevated for 24 hrs.

o   Collected blood and used instruments must be discarded as per BMWM

RULES 2016 (annexure 1-4)

o   Light and carminative diet is advised

o   Can be done once - in a single sitting

8.6] INCLUSION CRITERIA:

o   Patients between 25-45 years of age, irrespective of gender, caste, and religion will be included.

o   Patients who had been pre-diagnosed with sciatica under lower back ache.

o   Subjects who are ready to give consent for trial with firm residential address and contact numbers

8.7] EXCLUSION CRITERIA:

1. Patients with similar Musculo-skeletal conditions like sciatica but with other causes for lower back ache.

2. Patients with other systemic disorders e.g, CAD, HTN, HIV, DM, TB, HBsAg reactive etc. or any debilitating conditions.

3. Pregnant women and lactating mother.

4. Patients with Hb below 10gm% and deranged bleeding and clotting time

5. Patients diagnosed with specific diseases-spinal malignancies, spinal infection, inflammatory spondylitis and other malignancies

6. Gridhrasi due to traumatic injuries.

7. Gridhrasi developed due to any post-surgical complication

8. Gridhrasi associated with systemic/metabolic disorders.

9. Congenital deformity of vertebral column.

8.8] Withdrawal Criteria:

The subject will be withdrawn from the trial if

1. Patient develops any adverse effect.

2. There is non-compliance to treatment or therapy, or there is any other serious physical or mental problem that may hinder adherence to trial

3. The condition of the subject deteriorates during course of treatment.

4. He or she wants to withdraw from the trial.

8.9) Sample Selection Technique:

The patients diagnosed with Sciatica as per operational case definition and fulfilling all the mentioned inclusion criteria while at the same time devoid of any exclusion criteria will be further asked to provide consent for the study. The patients who give written consent for the trial will be finally selected and randomly divided in 2 groups by lottery method.

8.10] Grouping :

    i.    Grouping

          2 group each with minimum of 10 patients who are fulfilling the criteria for inclusion.

8.11] OUTCOMES

8.11.1. PRIMARY OUTCOME

•        Assessment of preferred anatomical site for siravedha above and below knee joint.                          

•        Assess the more effective anatomical site for the siravedha.

8.11.2 SECONDARY OUTCOME

      • Improvement in visual analogue scale for pain intensity

      • Improvement in Gradation of cardinal parameters

8.13] Duration of Trial:

•        Intervention of site Above & Below knee joint for siravedha :28 days on single patient

•        Total duration of study – 12 months

•        Follow up: 1^st – Day 14^th , 2^nd – Day 21th , 3^rd – Day 28^th

•        Timeline of intervention: 1-28th day

9] Statistical Analysis:

Statistical analysis will be carried out to obtain the percentage relief to assess the efficacy of the therapy. The data generated in the clinical study will be analyzed by applying appropriate statistical method. Data will be analyzed at the end of study period by using appropriate "Student T-test", "Wilcoxon Signed Rank test", and other relevant statistical tests of significance, needed to implement as the study demands during its duration. The results will interpret as:

§  Significant p<0.05

§  MiInsignificant p>0.05

10] Observation and Results:

Data of all observed patients will be obtained in physical form with predesigned proforma for subject screening, history taking and assessment forms for follow up. Excel sheets for digital record will be made in two copies, one copy will remain with investigator and second copy will be submitted to department for future references.

11] Discussion and conclusion:

The discussion and conclusion will be drawn on the basis of statistical analysis and symptomatic relief of overall assessment.

12) Scope and implication of proposed study:

·       Scope: The site assessment for siravedha below knee joint will be equally or more effective in the management of Gridhrasi (Sciatica). Thus, this study would provide evidence-based research on action of     the pain management of the siravedha in the disease.

             Trial with other forms para-surgical procedures.

·      Implication: If the study comes out to be successful, it will be very beneficial, easy to conduct, cost effective treatment and without any added side-effects to the patients of Gridhrasi

·     Limitations: The blood loss will be limited (40-50 ml) for siravedba in this study as it depends on the pooling of the blood in the veinal circuit, which should be taken in serious account by the doctor while performing the procedure and so that the arising complications will be dealt effectively.

13 DECLARATION: 

1. Study will be conducted within the stipulated time.

2. Study will be started after approval of IEC & research Performa will be made for study.

3. Study will also be registered in CTRI

A.    PICO Model :-

                                                           PLAN OF STUDY

 1. Initial assessment will be done (before starting treatment )

 2. Randomization of sample will be done by computerized table method.

 3.Treatment plan explained and consent will be taken.

A) GroupA                                                                    B)Group B

      Siravedha Above knee                                               Siravedha below knee joint

4)   Observations

5)   Discussion

6) Conclusion