MedPath

To manage pain in cervical region with marma chikitsa and abhyanga-nadi sweda

Phase 3
Not yet recruiting
Conditions
Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: MANYASTAMBAH, (2) ICD-10 Condition: Z729||Problem related to lifestyle, unspecified. Ayurveda Condition: MANYASTAMBAH,
Registration Number
CTRI/2022/10/046713
Lead Sponsor
Parul Ayurved Hospital
Brief Summary

A COMPARATIVE CLINICAL STUDY ON THE EFFICACY OF *MARMA* *CHIKITSA* WITH AGNIKARMA IN THE MANAGEMENT OF *MANYASTAMBHA* W.S.R TO CERVICAL SPONDYLOSIS

 NEED OF STUDY

•       *Manyastambha* is a disease mentioned in Ayurvedic classical texts and is characterized by stiffness or rigidity of the neck, followed by pain where neck movements are impaired. It is considered as one among the *nanatmaja vata vyadhis*.About 10 million persons per year affected in India alone. Prevalence of Cervical Spondylosis is similar in both sexes although degree of severities greater in males. The prevalence of sciatica varies considerably ranging from 2% to 45% . C most 4-7 commonly affected.

•        In the present era, *Manyastambha* is a commonly occurring disease, which may be correlated to cervical spondylosis due to the similarity of their symptoms. The frequency of its occurrence can be attributed to change in lifestyle, stressful conditions, travelling, improper sitting and sleeping postures, excessive use of computers, irregular working orders and dietary habits. Cervical spondylosis is one such disease which adversely affects quality of life for its heavy disease burden and also affects economically for its high treatment costs.According to a study there is a great association between cervical spondylosis and migraine, those with cervical spondylosis commonly exhibit a higher risk of migraine than those without cervical spondylosis. This Cervicalgia affects work life where a person never want to waste his precious working day, also faces difficulty in performing routine activities in the later stages of the disease causing disturbed social life.

•       As per modern science, the treatment line for cervical spondylosis includes administration of anti-inflammatory, antibiotic drugs, conservative treatment such as stretching exercises, neck belt and repeated injections of botulinum toxins for temporary relief which may help to act on initial stages of this disease where there are inflammatory changes. When the disease progresses to the next stage, degenerative changes in bones of cervical region occurs and this can be effectively managed by *snehana* and *swedana* procedures and also with *Marmachikitsa*. In Ayurveda, *snehana* and *swedana* the is the commonest management of *manyastambha*.

•        In *mamachikitsa* there is a need to focus on manipulating and stimulating *marma* points in the management of diseases. As a treatment point of view, *Marmachikitsa* acts as an easy and quick solution to resolve such problems. A judicious application of pressure on appropriate *marma* can restore the normal functioning of prana (in diseased body parts).

•       Till now there are not much research work done on marma for therapeutic significance. So this topic needs to be explored for the benefit of Ayurveda faternity and mankind.

•       Hence, this study is planned to compare the effects of *Marma* therapy with Agnikarma in the management of *manyastambha*.

•       The major advantage of this study is that it is cost effective and non-invasive.

**RESEARCH QUESTION**

•       Whether the *Marma* *chikitsa* will prove to be more effective in comparison with that of Agnimarma adopted in *Manyastambha*?

**AIM**-

•       To evaluate the comparison   of *Marma* *chikitsa* and agnikarma in *Manyastambha* w.s.r to Cervical spondylosis.

**OBJECTIVE**

•       To study the effect of manipulation and stimulation of *Marma* points as in the management of *Manyastambha*.

•       To study the effect of *Agnikarma*in the management of *Manyastambha*.

•   To compare the efficacy of *Marma* therapy with Agnikarma in the management of *Manyastambha*.

**HYPOTHESIS-**

**H0**

•       **(Null Hypothesis)**

Nither *Marma* *chikitsa* nor *Ankara*procedure is  effective  in the management of *Manyastambha*.

•       **(Alternate hypothesis)**

**H1** *Marma* *chikitsa* is more effective than *agnikarma*in management of  *Manyastambha*.

. **• H2***Agnikarma*is more effective than marma chiktsa  in  management of  *Manyastambha*.

• **H3***Marma* *chikitsa* and *Agnikarma*  have similar effects in management of *Manyastambha*.

**MATERIALS AND METHODS**

**SOURCES OF DATA –**

1.Literary source – All classical, regional literature, modern literature and contemporary texts including the journals and internet sources about the disease, drug and procedures will be reviewed and documented for the study.

2.Clinical source – 144 cases of will be selected for the study from the IPD and OPD of Smt.Urmilla Devi Ayurvedic College of Medical Sciences and Hospital, Hoshiarpur.

 METHODS OF COLLECTION OF DATA 1. Sample size – 144

Group A – Trial

Group B – Control

2. Study design – Randomized controlled clinical trial

 3. Duration of treatment – 14 days

4. Follow up after – 14 days and 1 month

5. RESCUE MEDICINE: In case of condition suggestive of possible deterioration of health appropriate measure will be taken.

*yogaraja Guggulu ,bruhatvata Chintamani rasa*

**INCLUSION CRITERIA**

•      Aged between 20 to 60 years.

- Patient fulfilling diagnostic criteria will be included in the study.

- Patient irrespective of gender, religion,occupation ,socio-economic status etc.will be included in this study.

• Having the classical signs and symptoms of cervival spondilosis *stabdhata* (stiffness),*ruk* (pain), *toda* (pinning sensation)

- Patient with controlled diabetes mellitus and other systemic diseases such as hyperthyrodism and hypothyrodism.

- Patient fit for marma therapy

- Both gender patients attending the OPD and IPD of will be included.

**EXCLUSION CRITERIA**:

•       Patients below the age of 18 and above the age of 60 were excluded.

•       Patients suffering from malignancy, major disorders of spine and major generalized diseases like C.C.F, IHD, Diabetes, renal disorders and immune compromised patients were excluded.

•       Patient who need other emergency intervention like surgery.

•       Patient suffering from cervical myelopathy and cervical radiculopathy will be excluded.

•       Pregnant, menstruating females and breast feeding mothers will be excluded.

•       Chronic cases of cervical spondylosis with history of more than 2 years.

•        Subjects with evidence of congenital anomalies of the spine, cervical fractures, trauma ,epidural abscess , Pott’s spine ,CA etc.

•       Refusal to provide consent for the study.

**STANDARD OPERATING PROCEDURE FOR *MARMA* THREAPY**

*PURVA KARMA:*

·       Check all the vitals of the patient.

·       Check the food taken is digested.

·       Keep at least 3 to 4 hours of gap after meals.

·       Cleaning of area to be operated with cotton, cloth or soft towel.

·       Noise free room with one helper technician specially in case of female patient, one female technician should be there as per protocol.

*Pradhaan Karma:*

- Make the patient to sit in comfortable position.

- Advise him/her to feel relax and take stable breaths.

•       Two types of *marma* methods are used – *Marma* manipulation and Stimulation.

 **MANIPULATION:**

·       It is the mechanical force used to correct the pathology

·       There are different types of tractions used accordingly to the site and condition.

·       Manipulation done in required condition.

**PROCEDURE:**

- Elicit the painful point

- Give slight movements on the affected area with little pressure and support

- Done only on first day of treatment.

**STIMULATION:** Pressing and releasing on vital spots for increasing local energy and pain reduction.

**PROCEDURE:**

•       Stimulation of *marma* points ( Amsa *marma* , *krikatika* *marma* ,*urvi* *marma,Karpura marma ,manibanda and kaipra marma*)one by one 12/16/18 times/point according to severity for mild, moderate, sever respectively with suitable intensity of pressure.

**VARIOUS INTENSITY OF PRESSURE AND IT’S INDICATION:**

•       **¼ *matra* pressure -** Superficial pressure

Pressure intensity equal to that of touched with either side of the thumb.

•       **½ *matra* pressure**    - Intensity equal to that of half the portion of soft pulp of the first interphalangeal joint of the middle finger

•       **1 *matra* pressure**     - Intensity equal to that of soft pulp of first interphalangeal joint of the middle finger / deep pressure.

•       Advice the patient to exhale on every stimulation with finger/thumb/palm (According to *mathirai* pressure) and inhale on releasing pressure.

·       After two rounds of initiation of *Marma* points, smear finger/palm with lukewarm medicated oil and gently apply over *marma* point.

·       Give 2 sittings to patient in a day for 14 days regularly.

*PASCHAT KARMA:*

·       Check all the vitals of the patient again.

·       Patients should take complete rest for at least 10 to 15 minutes.

·       Patient can take bath with lukewarm water after rest.

·       After treatment to each patient, it is necessary to touch the wall or any wooden object before treating the next patient, this is to avoid the transfer of the body heat from one patient to another.

**STANDARD OPERATING PROCEDURE  FOR  ABHYANGA  AND NADI SWEDA**

**Purva Karma:**

• Moisten the skin surface before starting Abhyanga with towel dipped in lukewarm water.

• Check the food taken is digested or keep at least 3-4 hours of gap after meals.

• Check the vitals of the patient before Abhyanga.

• Easy garments to wear according to part exposed and oleation to be done.

**Pradhaan Karma:**

1. Instruct the patient  to lie in prone posture on panchkarma table

2.  Sthanika abhyanga is administered (head ,neck ,shoulders region)to the patient.

3.After abhyanga give nadi sweda with dashamoola quatha to the patient.

    **Paschyat Karma:**

1.Patient should take complete rest for at least 15 minutes in comfortable position.

2. Check the vitals of the patient.

3. Patient can take bath in leukwarm water after rest.

**ASSESSMENT CRITERIA**

Assessment of the effect of treatment will be done with following parameters.

**SUBJECTIVE CRITERIA:**

**Subjective parameters:** parameters will be assessed on 1st, 7th and 14th day.

**Manyashoola (pain)** by VAS Analogue scale

 

| | |

| --- | --- |

|**GRADING (*MANYASHOOLA*)**

**ASSESSMENT**

|Grade 0

No pain

|Grade 1

Mild, Pain occasionally (1-3 score)

|Grade 2

More than mild but tolerable pain (4-6 scores)

|Grade 3

Severe pain, continuous (7-10 score)

**b)*Stambha* (Stiffness)**

| | |

| --- | --- |

|**GRADING**

**ASSESSMENT**

|Grade 0

Absent

|Grade 1

Mild, occasionally

|Grade 2

Moderate, for 30-1 hr daily

|Grade 3

Severe, persistent

- ***GAURAVA*** **(Heaviness)**

| | |

| --- | --- |

|GRADING

ASSESSMENT

|Grade 0

Absent

|Grade 1

Mild, occasionally for 10-30 mins

|Grade 2

Moderate for 30-1 hr

|Grade 3

Severe persistence>1 hr

 â€¢       ***CHIMCHIMAYAN*** **(Numbness)**

| | |

| --- | --- |

|GRADING

ASSESSMENT

|Grade 0

No *chimchimayan*

|Grade 1

Mild, occasionally

|Grade 2

Moderate, during work

|Grade 3

Severe, continuous

 â€¢       **OBJECTIVE PARAMETERS**

| | |

| --- | --- |

|CERVICAL MOVEMENT

NORMAL MOVEMENT IN DEGREE

|1. Flexion

50

|2.Extension

60

|3.Left and Right flexion

45

|4.Right and Left Rotation

80

 â€¢       **MOBILITY FLEXION**

| | |

| --- | --- |

|GRADING

ASSESSMENT

|Grade 0

Normal i.e., 50 degrees, able to touch chin & chest

|Grade 1

38 to 49 degree of total neck movement

|Grade 2

25 to 37 degree of total neck movement

|Grade 3

13 to 24 degree of total neck movement

|Grade 4

No flexion of neck

- **EXTENSION**

| | |

| --- | --- |

|GRADING

ASSESSMENT

|Grade 0

Normal i.e., 60-degree extension of neck upto back

|Grade 1

45 to 59 degree of total neck movement

|Grade 2

30 to 44 degree of total neck movement

|Grade 3

15 to 29 degree of total neck movement

|Grade 4

No extension of neck

- **LATERAL FLEXION (RIGHT & LEFT)**

| | |

| --- | --- |

|GRADING

ASSESSMENT

|Grade 0

Normal i.e., 45-degree ear touch to shoulder tip

|Grade 1

34 to 44 degree of total neck movement

|Grade 2

23 to 33 degree of total neck movement

|Grade 3

12 to 22 degree of total neck movement

|Grade 4

No flexion of neck

 â€¢       **ROTATION OF THE NECK (RIGHT & LEFT)**

| | |

| --- | --- |

|GRADING

ASSESSMENT

|Grade 0

Normal i.e., 80 degrees, able to make complete rotation

|Grade 1

60 to 79 degree of total neck movement

|Grade 2

40 to 59 degree of total neck movement

|Grade 3

20 to 39 degree of total neck movement

|Grade 4

No rotation of neck

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
144
Inclusion Criteria
  • 1 Aged between 20 to 60 years.
  • 2 Patient fulfilling diagnostic criteria will be included in the study.
  • 3 Having the classical signs and symptoms of cervival spondilosis stabdhata (stiffness),ruk (pain), toda (pinning sensation) 4 Patient fit for marma therapy.
Exclusion Criteria
  • 1 Patients below the age of 18 and above the age of 60 were excluded.
  • 2 Patients suffering from malignancy, major disorders of spine and major generalized diseases like C.C.F, IHD, Diabetes, renal disorders and immune compromised patients were excluded.
  • 3 Patient who need other emergency intervention like surgery.
  • 4 Patient suffering from cervical myelopathy and cervical radiculopathy will be excluded.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To assess the effectiveness of manipulation and stimulation of Marma points for fast relief pain and stiffness as in the15th day
management of Manyastambha.15th day
Secondary Outcome Measures
NameTimeMethod
To standardise the procedure of manipulation and stimulation of Marma points as in the management of Manyastambha.1 year

Trial Locations

Locations (1)

Parul Ayurved Hospital,Urmilla ayurvedic medical college and hospital

🇮🇳

Vadodara, GUJARAT, India

Parul Ayurved Hospital,Urmilla ayurvedic medical college and hospital
🇮🇳Vadodara, GUJARAT, India
Dr Bhopinder Singh
Principal investigator
7006333297
bhopinderthakur1@gmail.com

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