Comparative Evaluation of Efficacy of Modified Ashmaghnasveda (Stone Therapy) and Choornapindasveda in Management of Katigraha (Lumbar spondylosis)

Background: Katigraha is one of the most common illnesses affecting the Kati area, in which Vata gets are unbalanced in their own sthana (seat), resulting in Graha (stiffness) and Ruja (pain). Lumbar Spondylosis is a disease that causes back discomfort caused by spine movement and is accompanied by rigidity. Ashmaghnasveda is a key svedana treatment that helps with vataja, particularly Sama vataja and vatakaphaja illnesses. In this project, a structurally modified form of Ashmaghnasveda will be employed to produce ekangasveda. The goal of this study was to assess the efficacy of modified Ashmaghnasveda (stone therapy) and churnapindasveda in the treatment of Katigraha (lumbar spondylosis). Methodology: A total of 64 patients will be enrolled, and they will be evenly divided into two groups. Modified Ashmaghnasveda will be performed for 14 days in GroupA(Interventional). Churnapindasveda will be performed for 14 days in GroupB (comparator group). Expected Results: The objective parameters will be monitored and documented as they change. Conclusion: Based on the information gathered, conclusions will be reached. Study Protocol Jain and Sawarkar; JPRI, 33(62A): 23-31, 2021; Article no.JPRI.80051 24


INTRODUCTION
Katigraha is a disease that affects the Kati region and causes Vata to become imbalanced in its own sthana. According to Gadanigraha, when Vata is impacted by Ama and lands in Kati pradesh, it manifests Katigraha symptoms such as Graha (stiffness) and Ruja (pain) in Kati pradesh (lower back). [1] Katigraha was also emphasised by Acharya Sharangadhara, who placed it under the heading of NanatmajaVatavyadhi. [2] Katigrahais often compared with chronic low back pain due to similarity in clinical manifestations. Lumbar Spondylosis is a similar disease which is diagnosed as back pain induced by spine movement and associated with stiffness. [3] Chronic low back pain is diagnosed when pain lasts more than 12 weeks and accounts for almost 50% of total back pain costs. Risk factors include obesity, females, old age, history of back pain and restricted spinal mobility due to any other reason. [4]Various studies have been performed with low back pain as a major complaint, in which Vataghna and Vatakaphaghna measures including both oral medication as well as Panchakarma procedures displayed highly significant results in all the subjective and objective parameters of Katigraha.
Amongst these, Svedana is one which is defined as one which relieves one of Stambha, gaurava, sheeta and also produces Sveda (Sweat). [7] While explaining its benefits, Acharya Charaka states that it induces sweating, relieves one of pain, stiffness, heaviness and brings softness in the body. [8] While Acharya Sushruta states that it helps in achieving improved mobility of the joints which have stiffness. [9] Itis indicated in diseases of many systems like respiratory, neuromuscular diseases, musculoskeletal system such as Gridhrasi, Stambha (stiffness), Khalli etc. [10] and also found useful in Ankylosing spondylitis [11], Osteoarthritis [12], Sciatica [13].
Many studies have been done on effects of localized treatments on Katigraha, Katishula etc. e.g. "Katibasti with RasnadiTaila along with Shunthi-Erand Yoga" were found to be very effective in the management of Katishoola. [16]; use of Churnapindasvedain Katigraha was also found to have significant results. [17], [18] Churnapindasvedais a type of rukshasankarasvedawhich is beneficial in vatakaphaja or samavataja diseases. [19] Ashmaghnasveda (Charaka) [20]/ GhanshmaSveda (Vagbhatta) [21], [22]is one of the major svedana procedures which is especiallybeneficial in Sama vataja and vatakaphaja diseases. [23] In its traditional form Ashmaghnasvedais a type of sarvangasveda, in which a stone slab of the size of height of a person is used to induce sarvangasveda and is one of the mahana(strong)svedana karma. [24] This treatment is not being used frequently due to various reasons like tedious and prolonged process, needing a lot of medicinal resources and manpower thereby increasing the cost of treatment due to which it is gradually becoming a lost treatment modality.
Stone massage/ stone therapy being used in various Spa centres and other traditional system of medicine is a relaxing treatment which can be considered as a modified alternative of Ashmaghnasveda, which incorporates the benefits of massage, heat therapy and acupressure all at the same time. The stone massage has a form of impact on the body which uses mechanical stimuli viz. pressure on the tissues to induce desired physiological reactions. [25] In many countries hot stone therapy for whole body or spine is also being used for treatment of stiffness, aches, stress and anxiety etc. in which a stone slab is directly heated while a person lays on it and has shown very good results. [26]This hot stone therapy lacks the use of medicinal effects of herbs which are used in the case of AshmaghnaSveda. Considering all this it will be beneficial to find out if Ashmaghnasveda can be structurally modified to be given locally with the help of smaller stones instead of a stone bed which can provide a better treatment option while reducing medical costs.

RATIONALE
Treatment of Lumbar spondylosis includes antiinflammatory, analgesics, muscle relaxants, Nonsteroidal anti-inflammatory drugs or NSAIDs, exercises, traction, absolute bed rest and invasive treatments such as surgeries. [27]Limitations of these therapies include various side effects in pain relieving group of medicines like NSAIDs, reduced work output and change in lifestyle of the patients in case of bedrest, patients not willing to undergo surgeries due to fear etc. Considering all this a structurally modified technique of Ashmaghnasveda; providing it in the form ofekangasveda(stone therapy) will be utilized in the current study. Stone therapy/ stone massage can be done with small stones to induce localised effects but lack the use of medication unlike in the case of Ashmaghna Sveda. Ashmaghnasveda is one of the mahansveda mentioned in the Ayurvedic literature and is mentioned to be useful in various types of Vatavyadhi. Mahan sveda is given in conditions where the vyadhibala is strong, is associated with kapha or Ama like in Katigraha and patient is also strong enough to take the treatment.
In clinical practice Ashmaghnasveda has been becoming obsolete due to very high requirement of raw herbs, specific pre-and post-procedure requirements, and increasing cost of medicinal herbs which are burned to heat the stone slab. Stone massage therapy is a traditional treatment practiced in various countries and has shown promising results in reducing pains and relaxing muscles and stress. But in this therapy the stones are not heated with the herbs of medicinal properties.
Considering the above literature, it will be beneficial to modify the Ashmaghnasveda into localized treatment which will not only help in reviving a treatment which is becoming obsolete but also provide for new treatment option which is beneficial to society. , it will be beneficial to find out if modified Ashmaghnasveda can be given to Ekanga (locally) which will help in reducing the waste generated at the hospital & to reduce the need of IPD admissions as the treatment can be carried out as a day care treatment.
Thus, considering the prevalence, disability rate in productive part of life, intensity of symptoms of disease and considering classical reference of efficacy of Ashmaghnasveda, and reference of use of Churnapindasveda [15]in Katigraha a randomised clinical study will be conducted to assess its efficacy in Katigraha. Some  In NiramajaKatigraha: An Open Clinical Trial [28] concluded that PanchakoladiUpanaha was effective in relieving Samaja stage of Katigraha and Avasthanusara treatment is more effective in the management of Katigraha than that of Anavasthanusara treatment, important takeaway from this study was Upnaha is a localized treatment which showed promising result and author highlights the fact that localized treatment holds good results in the treatment of Katigraha. Mishra G et al in Clinical Study to Evaluate the Effect of Modified Choorna Pinda Svedain the Management of Katigraha (Lumbago) maximum patients got marked improvement which is statisticallysignificant; neither any patient got complete remission, norremains unchanged however, the limitations on this study were that only one treatment group was used and Svedana was performed on whole body, while author also agrees that the disease is localized, in such case localized treatment can show better results.

Sharma P et al in Comparitive Clinical Study of ArohanaMatra Basti And Standard Matra Basti In KevalaVatajaKatigraha
Vis-À-Vis Lumbar Spondylosis [29]and Bhende et al Comparative clinical study of Ashwagandha and Chincha tail Matrabasti [30] concluded that statistically significant results were seen in both the groups which confirm effect of Matra Basti in Kevalavatajakatigraha to be veryeffective, but it had limitations of having a small sample size and treatment administered being basti for which there is hesitation and non-compliance.
From the above-mentioned works done we can see that plenty of work has been done on katigraha, but no work has been done on ghanashmasveda or stone therapy in Ayurveda. It can also be inferred than many authors insist on use of local treatment in the cases of Katigraha. The limitations of the above established treatment have already been discussed which makes it essential to look for a cost effective, non-invasive treatment modality which can be done at OPD level with minimal generation of hospital waste. Therefore, Modified form of Ashmaghnasveda (stone therapy) is being chosen for evaluation in this study.

Study Type
Interventional study.

Trial Design
Superiority clinical trial i.e. A randomized control trial(RCT) -Reference standard control trial, open study.

Diagnostic Criteria
1. Katigraha (Stiffness in lower back) 2. Katishoola (Low back pain) for more than 12 weeks 3. Reduced walking capacity due to pain

6 Research Question
Whether modified Ashmaghnasveda(stone therapy)is more effective than churnapindasveda in patients of Katigraha (Lumbar spondylosis)?

Inclusion criteria
 Patients without barring any gender between 21 to 40 years of age.  Patients diagnosed as a case of Katigraha (Lumbar spondylosis ICD code M 47.8)will be selected irrespective of gender/ occupation and socio-economic status.  Patients having low back ache for more than 12 weeks  Patients willing to give informed consent.

Exclusion criteria
 Patients reporting with low backache due to spinal tumour, malignancy of the pelvis, tuberculosis of vertebral bodies, Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis, Gouty Arthritis and congenital deformity.  Low backache associated with Myelopathy and radiculopathy  Post-surgical backache and history of lumbar surgery or implanted instrumentation or prostheses.  Pregnant women, lactating mother and women undergoing menstruation.  Patients with the history of trauma (Abhighatajanya Katigraha).

Criteria for discontinuing or modifying allocated interventions
 Patients willing to quit in between will be allowed to quit and will be replaced.  If patient develops any acute illness during the trial which may hamper the study.  Withdrawn patients will be replaced.  If any untoward incidence, features of drug sensitivity or any other disease or problem arises, the subject will be offered free treatment till the problem subsides.

Followup
28 th day of study.

Assessment Criteria
The improvement will be assessed on the basis of relief in sign and symptoms of Katigraha. All the sign and symptoms will be assigned score depending upon their severity to assess the effect of treatment, the details of which are given below: A. walk distance test (2MWD) [35] will be used to measure the functional improvement in walking capacity.

Primary
Primary outcome is reduction in pain, stiffness and difficulty in walking in cases of Katigraha.

Participant timeline
14 days treatment and follow up on 28th day of study.

Methods: Assignment of Interventions (for Controlled Trials)
Recruitment: Patients will be recruited by randomization sampling method. The PI and Supervisor will allocate and enrol the patient.
Phase I -Pilot Study -12 patients were taken for treatment as thumb rule according to which sample size was calculated.
Phase II -Main trial for which sample size was calculated according to Pilot study. 64 patients are required to have a 90% chance of detecting, as significant at the 5% level, an increase in the primary outcome measure from 32% in the control group to 70% in the experimental group.

Data Collection, Management, and Analysis Methods
Observations will be made after completion of study, according to the data collected with the help of following: I. Case registration Form with detailed history and examination (Annexure I) II.

Data Monitoring
The Data coding will be done by PI and supervisor.

Statistical Methods
Data obtained will be calculated by using Student's Paired and Unpaired 't' test. Data on continuous variables will be analysed using parametric tests. The data on discrete variables will be presented as n (%). The continuous data will be presented as mean (SD)/Median (Min-Max). A p value of less than0.05will be considered as significant.

DISCUSSION
Discussion will be drawn according to the observations made in the case registration and follow up forms.

CONCLUSION
The modified Ashmaghnasveda (stone therapy) will be more effective in management of Katigraha (lumbar spondylosis) as compare to churnapindasveda in management of Katigraha (lumbar spondylosis).

CONSENT
The written informed consent will be taken from the patient before starting the study. During the study the confidentiality of each patient will be maintained.