Title: An Open Randomised Controlled Clinical Study to Evaluate Efficacy of Marma Therapy in Mechanical Low Back Pain.

1. Introduction:

Low back pain (mentioned commonly as lumbago) is a common symptom of musculoskeletal disorders of the lumbar vertebrae. It may be acute, sub-acute or continual in its medical presentation. These days, this condition is mostly found in women who perform or who carry out ahead bending works. As many ladies are regarding in numerous residences works like a cleansing of houses, washes utensils at domestic or works in gardening through bending which in results in backache. Acute low back pain is one of the reasons for adults to see a family physician. Most of the time patients recover with or without treatment, and in some cases, it requires bed rest as well as prompt treatment.

Rationale of study:

In order to overcome the problem, as the low back pain becomes a troublesome problem with a number of patients generally visit practitioners, often it is treated with painkillers like non-steroidal anti-inflammatory drugs (NSAIDs) and it is now time to search for a costeffective remedy and need to prove its effectiveness is necessary, and in the current scenario there are no specific drugs or treatments are available for such a disease, other than pain relievers, which are also prone for its side effects, secondary problems. It is evident that modern approaches to medical management for this disabling condition have many limitations. Ayurvedic treatments also require specially trained staff, expensive drugs and time-consuming therapies. In such a situation, the practice of yoga makes the body strong and flexible; It also improves the functioning of the respiratory, circulatory, digestive and endocrine systems. Asana offers emotional stability and mental clarity. All these benefits are added in time and cost savings with common practice.

As far as Ayurvedic treatment concerns the treatments became strictly body-oriented like Panchakarma Therapy and other medicinal treatment. Marma brings the mind energy to the body elements and therefore Marma Ayurveda becomes a mind-body system, Marma Therapy is superior to only Ayurvedic treatment for such conditions as Marma therapy pulls the mind energy into the treatment and elevates the efficacy. Marma strengthens the energy channels between the mind and the body. The free flow of energy through these channels enhances the effectiveness of the conventional Ayurvedic treatment. Marma or energy points within the body are situated in the body. By activating or pressing these points, the link to the mind is reinforced and ultimately back pain reduces substantially and the patient has mobility or can work better, it will reduce the cost as well as bed rest and dependency on pain killers.  At the same time, Marma therapy is also non-invasive management for this condition of low back pain. A variety of treatments are available for acute low back pain, but strong evidence for their benefit is lacking.  That is why I have selected the topic and proven its relevance in terms of cost-effectiveness, reduction in the duration of bed rest and dependency on pain killers, thus the study topic entitles “An Open Randomized Controlled Clinical Study to Evaluate Efficacy of Marma Therapy in Mechanical Low Back Pain.”

4.    Research question:

Does Marma therapy have significant role in reduction of mechanical low back pain?

5.    Hypothesis:

Null Hypothesis: Marma therapy is significantly not effective in mechanical low back pain.

Alternative Hypothesis:  

Marma therapy is significantly effective in mechanical low back pain

6.    Aim and objectives:

Aim: To evaluate the efficacy of Marma Therapy in the management of mechanical low back pain.

Objectives:

a.     Primary 

To determine the efficacy of Marma therapy in mechanical low back pain.

b.     Secondary 

1.     To evaluate and overcome the dependency on pain killers for mechanical low back pain. 

2.     To overcome the cost of the treatment and to make the cost-effective treatment for the patients.  

4.    Methodology:

7.1 Study design (Flow chart): 

Open, Randomized controlled clinical trial

7.2 Study population and sampling: The patients suffering from low back pain and attending OPD or IPD of the Swasthvritta and/or Kayachikitsa or Shalya Department of the Hospital.

7.3 Sampling methods: non-probability - convenience sampling method

7.4 Study Site: Ayurveda College Hospital

7.5 Sample size: 

According to this study, the occurrence of low back pain in India is nearly 60% at some time during their lifespan.²³

Determination of sample size:

n = Zpq/l²

n = Required sample size

Z = confidence level at 95% (Standard value of 1.96) l = Margin of error at 10%  p = prevalence low back pain is 60% = [(1.96x1.96) x 60 (100-60] / (10*10) 

= [(3.84) x2400/100

= 9216/100 = 92 with 10% drop-out, sample size will be 92+9=101, round up to 100. 

7.6 Data collection tools and process:

a. Inclusion criteria 

1.     Age group of 30-60 years of either sex. 

2.     Patients having mechanical low back pain.

3.     Patients who are willing to give consent for this study.

b.     Exclusion criteria 

1.     Contra-indications for Marma therapy and Yogasan like severe weakness, burn or any physical disability etc.

2.     Patients with history of Fracture of hip bone or TB spine, Pelvic inflammatory disease. 

3.     Any other Physical injuries to the hip joint(trauma) or dislocation of joint. 

4.     Pregnancy.

c.      Withdrawal criteria

1.     Occurrence of serious adverse effects.

2.     The protocol has been violated or patient has become uncooperative.

3.     The patient is not willing to continue the trial or to follow the assessment schedule.

7.8 Assessment Criteria:

A) Subjective parameters:

Oswestry Low Back Pain Disability Questionnaire (www.orthopaedicscores.com) 

 8.  Intervention:

8.1 Control Group:

Orientation programme:

 Before the start of the study intervention, 2 days of special training for the patients will be arranged to give orientation about the Asana procedure given for the management of low back pain. Emphasis will be given to appropriate procedures or how to perform these asanas. Every participant will be advised to do sharir sanchalan for fifteen minutes and then 10-15 times for Asana.  

Procedure:

 Yogic Practice shall start with a prayer or prayerful mood to enhance the benefits of practice. ॐ सगं >छ@व ं सवं द@वं स  à¤‚वो मनांिस जानताम ् दवे ा भाग ं यथा पवू H सIजानाना उपासते ।।

 May you move in harmony; may you speak in unison; let our mind be equanimous like in the beginning; let the divinity manifest in your sacred endeavors.

General instruction:

1.     All the patients will be informed about performing following Yoga in daily morning. 

2.     All patients will perform Shalabhasan, Bhujangasan and Ardhachakrasan followed by Shavashana.

3.     All postures holding time will be 15 to 20 seconds and each posture will be done 4 times

4.     Participant will be informed about clothing required for Yoga i.e., loose fitting or comfortable. 

5.     All the patients will be advised to come for Asana with empty stomach early in the morning.

6.     All patients will be trained the stepwise performance of every step of Each Asanas. 

7.     Asana:  

-        Shalabhasan Bhujangasan and Ardhachakrasan followed by Shavashana.

-        Time: 15 minutes for each session.

-        Timings of Asana will be managed according to the group and response of patients.

8.     Study duration: 2 weeks

9.     Chanting of “Om” for 5 minutes after that Asana will be performed.

8.2  Study group:

Marma Therapy:

 Adhipati, Krukatika, Ansa, Ansaphalak, Bruhati, Kukundar,  Pasrhawasandhi, Nitamba and katitarun. Marma therapy will be given once a day for 2 weeks. Patients will also be taught to do marma messages at home. Marma points will be activated once every day for 14 days.

All marma points will be activated by pressing it 10 times in one sitting only.

            If the patient is having severe pain and is not bearable during the trial NSAIDs like Diclofenac Sodium 50-100 mg will be given till pain subsides.

8.3  Data collection tools/ instruments:

1.     Case record Form (CRF)

2.     Clinical Examination

8.4 Methods of Data Collection relevant to the objective:

a.     Clinical Examination: A detailed Case Record Form including all the classic signs and symptoms of low back pain will be prepared. The basic demography of the patients will be also included in the case report proforma. 

b.     Literary source: A detailed review of the available literature on the disease, Marma Therapy and Yogasana, such as classical texts of Ayurveda, Yoga and Modern textbooks. Data will be collected from various books, periodicals and papers published in the national as well as international journals etc.

8.5 Study procedure and evaluation:

For this study eligible patients will be recruited of low back mechanical pain who report to OPD or IPD of the hospital attached to the Ayurvedic Medical College.

The study will include two arms:

Study Group: As per criteria of inclusion and at the same time, taking the consideration of criteria of exclusion likewise patients will be recruited. Detailed history will be taken prior to enrolment and it is recorded in CRF form., Marma therapy will be given to this group.

Control Group:  Similar procedure will be followed for the recruitment of the patients and Yogasana will be advised to this group.

1^st visit (0 day) will be screening visit: All the Clinical examination & radiological investigations will be done after detailed history. This visit will be considered as baseline visit. 2^nd, 3^rd, and 4^th visit will be after the interval of two weeks. In this visit clinical findings and will be recorded in (CRF) case record form.

8.6 Data analysis methods :

Data will be coded in MS excel worksheet. Data will be analyzed in statistical software, STAT, Version 10.1, 2011. Frequency and percentages will be used to summarize categorical variables like gender, marital status, occupation, education, different complaints of patients etc. percentage of relief will be calculated based on subjective & objective criteria.

Subjective symptoms will be statistically analyzed by applying suitable test like ‘Wilcoxon Signed Rank test’ within group to compare the results before and after treatment results. To compare the mean difference in more than two group ‘Freidman test’ will be applied for subjective parameter. Chi square test will be applied for variables to see the association. For the comparison between the groups for subjective criteria ‘Mann Whitney U’ Test will be applied. For quantitative variable ‘student test’ will be applied. Level of significance will be taken at 5%. 

Safe storage of data:

All the case record and informed consent will be kept in safe and secure place or in safe locker  in order to maintain its confidentiality. 

a. Randomization proposed

Yes, Randomization will be done of all the patients to equal allotment between two groups. AABB, ABAB paradigm method will be adopted for this purpose. b. Allocation concealment proposed: Not Applicable

c.      Blinding proposed: Not, it is open label study

c.      Inform consent: A well written informed consent will be obtained from all the patients explaining the details about the therapy given to them. This inform consent will be the language understood by the participant or in a vernacular  language.