NEED OF STUDY

The 2010 Global Burden of Disease Study estimated that low back pain is among the top 10 diseases and injuries that account for the highest number of DALYs worldwide. Low back pain is a very common health problem worldwide and a major cause of disability - affecting performance at work and general well-being. In the United Kingdom, low back pain was identified as the most common cause of disability in young adults, with more than 100 million workdays lost per year. In India, prevalence of the disease is around 6.2 percent in general population. India is still a developing country having low socioeconomic population which cannot afford much for ailments causing disabilities. Non-specific Low back pain (LBP) is the most common orthopedic problem that affects both younger and older adults.  Treatment of such ailments proves costly in Modern medicine as well as in Ayurveda by Shodhana and Shaman. Other than this, the side effects of analgesics are really horrifying especially in young generation. So now a days, people are getting more inclined towards non-invasive therapies like Marma Chikitsa, Cupping therapy, Acupressure etc. rather than going for oral medication or invasive therapies. Both Marma Chikitsa  and Cupping Therapy undertaken in study offer low-cost preventive type of therapy by which medical costing is reduced and health is improved. Thus, this study will be undertaken as an attempt to treat and manage Katigraha especially non-specific low back pain with both non-invasive therapies i.e., Marma Chikitsa and Cupping therapy and to evaluate that amongst the two which therapy is more effective.

RESEARCH GAP ANALYSIS:

 A scientific study of Parshvasandhi Marma w.s.r to Marma of Trunk Region- Dr Rajendra Prasad Gupta, Rachna Sharir Department, NIA, Jaipur. Year 1999.

 Kim JI, Kim TH, Lee MS, Kang JW, Kim KH, Choi JY, et al. Evaluation of wet-cupping therapy for persistent non-specific low back pain: a randomised, waiting-list controlled, open label, parallel-group pilot trial. Trials 2011 Jun 10; 12:146.

 AlBedah A, Khalil M, Elolemy A, Hussein AA, Al Qaed M, Al Mudaiheem A, et al. The Use of wet cupping for persistent nonspecific low back pain: randomized controlled clinical trial. J Altern Complement Med 2015 Aug 1;21(8):504e8.

 Farhadi K, Schwebel DC, Saeb M, Choubsaz M, Mohammadi R, Ahmadi A. The effectiveness of wet-cupping for nonspecific low back pain in Iran: a randomized controlled trial. Complement Ther Med 2009 Jan 31;17(1):9e15.

SELECTION OF INTERVENTION 

I. According to Ayurveda, the human body functions as a dynamic equilibrium governed by the three doshas: Vata, Pitta, and Kapha. These doshas are the primary regulatory forces that maintain physiological and psychological balance. Additionally, the body and mind are influenced by the three gunas Sattva, Rajas, and Tamas each representing distinct qualities of consciousness. Central to this system is the concept of Prana, the vital energy that animates the body and sustains life. Marma points, which are key anatomical sites where Prana is concentrated, play a critical role in the regulation of this vital energy. By strategically stimulating these points, Prana can be redirected to resolve blockages and restore energy flow, even to distant regions of the body. This process promotes a state of optimal health, encompassing the physical, mental, and spiritual dimensions. Marma Chikitsa, the therapeutic application of Marma stimulation, is a non-invasive modality known for its immediate and sustained effects. This approach facilitates treatment without the need for pharmacological interventions, offering a streamlined and holistic pathway to restoring homeostasis and enhancing overall vitality. So, this study effort was taken up to find out effect of this non pharmacological therapy in the management of Katigraha with special reference to Non specific low back pain. 

II. The application of cupping therapy in low back pain is justified by its multifaceted approach to pain relief. By combining the principles of Ayurvedic medicine, which focus on restoring doshic balance and enhancing Prana flow, with the physiological benefits of improved circulation, myofascial release, and detoxification, cupping therapy offers a holistic and effective treatment option for individuals suffering from low back ache. The therapy’s non-invasive nature, coupled with its potential for immediate and long-lasting relief, makes it a valuable addition to both traditional and modern pain management practices.

RESEARCH QUESTION

I. Whether Marma Chikitsa and Cupping therapy are effective in the management of Katigraha w.s.r to Non-specific low back pain ?

II. Which non-invasive therapy i.e., Marma Chikitsa or Cupping therapy is more effective in the management of Katigraha w.s.r to Non-specific low back pain ?

HYPOTHESIS

NULL HYPOTHESIS (H₀)- There is no difference in the effectiveness of Marma Chikitsa and Cupping Therapy  in the management of Katigraha w.s.r. to Non-specific low back pain.

ALTERNATE HYPOTHESIS (H₁)- There is difference in the effectiveness of Marma Chikitsa and Cupping Therapy  in the management of Katigraha w.s.r. to Non-specific low back pain.

AIM

 To explore the anatomical structural aspect of Prushthgata Marma  by Cadaveric Dissection.

 To evaluate and compare the effect of Marma Chikitsa and Cupping therapy in the management of Katigraha w.s.r to non-specific low back ache.

OBJECTIVES

PRIMARY OBJECTIVES

 To assess the efficacy of Marma Chikitsa in the management of Katigraha w.s.r to non-specific low back ache.

 To assess the efficacy of Cupping Therapy in the management of Katigraha w.s.r to non-specific low back ache.

 To record individual response of Marma Chikitsa & Cupping Therapy in the management of Katigraha w.s.r to non-specific low back ache.

 The anatomical structural aspect of Prushthgata Marma is to be explored by Cadaveric Dissection.

SECONDARY OBJECTIVES

 A comprehensive study of Katigraha and Non-specific low back pain by reviewing all relevant literature.

STUDY DESIGN-

Step 1- CONCEPTUAL STUDY

 Detailed study of Prushthgata Marma from all the classics and contemporary texts related to topic.

 Detailed study of Marma Chikitsa from all the relevant available literature.

 Detailed study of Cupping therapy from all the relevant available literature.

 Detailed description about the etymology, clinical manifestations, prognosis and general principles of management of Katigraha according to Ayurveda classics.

 Detailed description about the etymology, clinical manifestations, prognosis and general principles of management of low back pain according to modern medicine.

 Detailed description of Marma Chikitsa protocol and Cupping therapy protocol conducted during the study.

Step 2- CADAVERIC STUDY

 Cadaveric dissection of back with analysis of anatomical structures present at the location of particular Prushthgata Marma.

Step 3- INTERVENTIONAL STUDY

 For selecting samples for the randomized clinical trial, computer generated simple random sampling technique will be followed.

 Patients from both OPD and IPD of NIA, Jaipur and its related satellite hospitals will be considered for study.

 Patients will be screened based on diagnostic and selection criteria and will then be enrolled in the study.

 The total number of 90 patients having symptoms of moderate low back pain will be selected and divided randomly amongst the two trial groups so that there are 45 patients in Group A and 45 patients in Group B irrespective of their sex, habitat and religion.

DETAILS OF INTERVENTION

GROUP A- MARMA CHIKITSA (45 Patients will be given Marma Chikitsa)

u Therapy period- 14 days

u Follow up - after every 7 days

u Therapy protocol -17-18 stimulations in one sitting (2 sittings a day)

u Marma to be stimulated- Kukundar, Katikatarun, Parshvasandhi.

u Two sittings in a day, Total therapy time/day would be of 15 minutes.

u Safety Measures during Marma Therapy : If patient feels pain/ discomfort during therapy he/she will be withdrawn from the trial and would be treated as per symptoms.

GROUP B- CUPPING THERAPY (45 Patients will be given Cupping Therapy)

u Therapy period- 14 days

u Follow up - after every 7 days

u Therapy protocol - Dynamic method of cupping would be implied.

u Region of Cupping- Lower back region.

u Cup Material- Silicone Cup

u One sitting in a day, Total therapy time/day would be of 15 minutes.

u Safety Measures during cupping therapy: If patient feels pain/ discomfort during therapy he/she will be withdrawn from the trial and would be treated as per symptoms.

POSOLOGY:

FOR GROUP A: 17-18 stimulations of Marma points.

FOR GROUP B: 15 minutes dynamic method of cupping at site of low back pain.

INVESTIGATION- X-ray (AP view and Lumbar view of Lumbo-sacral spine) as per required.

ASSESSMENT CRITERIA-  For assessment, following parameters will be adopted-

1) According to Ayurveda: symptoms  like Vedana, Stambha and Chestanash would be analyzed as per Gadanigraha (Chapter 19, Verse 160)

2) According to Modern Text following parameters shall be adopted for assessing the Patients before and after treatment:

1. OSWESTRY LOW BACK DISABILITY QUESTIONNAIRE- The test has been around since 1980 and is considered the ‘gold standard’ of low back pain functional outcome tools. This questionnaire has been designed to give us information as to how your back pain has affected your ability to manage everyday life. ²⁵

SCORE DISABILITY LEVEL -

0 - 4 No disability

5 - 14 Mild disability

15 - 24 Moderate disability

25 - 34 Severe disability

35 - 50 Completely disabled

2. BACK PAIN VISUAL ANALOGUE SCALES (VAS) - Visual analogue scales (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain):

0-1- No pain

1-3- mild pain

4-6- moderate pain

7-9- severe pain

9-10- Most severe pain

3. Slump Test- It is a neural tension test used to detect altered neurodynamics.

4. Schobers Test- It is classically used to determine if there is a decrease in lumbar spine range of motion (flexion), most commonly a result of ankylosing spondylitis.

 OUTCOME

PRIMARY OUTCOME MEASURES 

u Change in intensity of symptoms of Katigraha as per Acharya Sodhal of Gadnigraha.

u Change in Intensity of symptoms of Non specific low back ache.

SECONDARY OUTCOME MEASURES-

u Change in grading level of  Oswestry Low Back Disability Level & VAS Scale before and after the treatment.

PRIMARY END POINT- Reduction in recurrence of Katigraha or non specific low back pain.

SECONDARY END POINT- Change in quality of life of patient.

BIBLIOGRAPHY

1. Gupta, Sanjay & Patil, Vaidya Vasant & Sharma, Radheyshyam (2016) Diagnosis and management of katishool (low back pain) in Ayurveda: A critical review. Ayushdhara- An International Journal of Research in Ayush and Allied systems. 3.764-769.

2. Atlas SJ, Nardin RA. Evaluation and treatment of low back pain: An evidence-based approach to clinical care. Muscle Nerve 2003 Mar;27(3):265-284

3. Taimela S, Kujala UM, Salminen JJ & Viljanen T. The prevalence of low back pain among children and adolescents: a nationwide, cohort-based questionnaire survey in Finland. Spine, 1997, 22: 1132–1136.

4. Musich S, Wang SS, Slindee LB, Keown K, Hawkins K, Yeh CS. Using Pain Medication Intensity to Stratify Back Pain Among Older Adults. Pain Med. 2019 Feb 01;20(2):252-266.

5. Pandit Parashurama Shastri Vidyasagar edited Sharangadhara Samhita, Deepika Commentory by Adamalla on Prathama Khanda, Chapter 7, Shloka No.105, 3rd edition 1983, Pub:Chawkambha Orientalia, P.B.32, K, 37/109, Gopal Mandir lane, Varanasi (UP), Page No.103.

6. Arunadatta Sarvangasundara vyakhya, Hemadris Ayurvedarasayanaahvaya teeka: Ashtanga Hridaya: Chaukambha Surabharathi Prakashan, Varanasi: Edition: 2018, Nidanasthana, Vatavyadhinidanadhyaya,15/7-8

7. Bhavaprakash of Sri Bhavmishra, with Vidyotini Hindi Tika edited by Sri Brahma Sankar Mishra, Chaukambha Sanskrit Bhavan. Edition:2013, vol II: Madhyamakhanda, Amavathadikara: 26/53: p. 286.

8. Prof. K.R. Srikantha Murthy edited Bhavaprakasha, Dwithitya khanda, 26nd Chapter, Shloka no. 53, Edition First 1998, Pub: Krishnadas Academy, Varanasi (UP).

9. Sri Ganga Sahaya Pandeya Edited Gadanigraha,Chapter 19, Shloka 160 Chaukhamba Sanskrit Samsthan K.37/117, Gopal Mandir lane, Post box No.1139, Varanasi (UP), Edition:Reprint 2005, Page No 508.

10. Bramhashankara M, editor BhavaPrakash of Bhava Mishra. Ch 26. Ver 53, Part 2. 12th Edition Varanasi Chaukhaamba Sanskrit Sansthan 2016. Page No 292.