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CTRI Number  CTRI/2024/12/078549 [Registered on: 24/12/2024] Trial Registered Prospectively
Last Modified On: 24/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study Comparing the Effectiveness of Marma Chikitsa and TENS Therapy in Cervical Spondylosis. 
Scientific Title of Study   A Randomized Comparative Clinical Study for the Efficacy of Marma Chikitsa and Transcutaneous Electrical Nerve Stimulation (TENS) Modality in the Management of Cervical Spondylosis  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akash Sanjeev 
Designation  Msc (Ayu.) Scholar 
Affiliation  National Institute Of Ayurveda, Deemed University, Jaipur 
Address  Department Of Marmalogy and Sports Medicine National Institute Of Ayurveda, Deemed University Near Jorawar Singh Gate, Amer Road Jaipur, Rajasthan 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  9048354269  
Fax    
Email  drakashsanjeev97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suman Sharma 
Designation  Associate Professor 
Affiliation  National Institute Of Ayurveda,Deemed University, Jaipur 
Address  Department Of Shalya Tantra National Institute Of Ayurveda Deemed University Near Jorawar Singh Gate, Amer Road Jaipur, Rajasthan 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  9418159666  
Fax    
Email  sumanhp2006@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manorma Singh 
Designation  Assistant Professor 
Affiliation  National Institute of Ayurveda, Deemed University, Jaipur 
Address  National Institute Of Ayurveda Deemed University Near Jorawar Singh Gate, Amer Road Jaipur, Rajasthan 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  7414810997  
Fax    
Email  docmanorma@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Ayurveda, Deemed University, Jaipur, Rajasthan, India, 302002 
 
Primary Sponsor  
Name  National Institute Of Ayurveda, Deemed University, Jaipur 
Address  Near Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan - 302002 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akash Sanjeev  National Institute Of Ayurveda, Jaipur  OPD Number-32, National Institute Of Ayurveda Hospital, Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan 302002
Jaipur
RAJASTHAN 
9048354269

drakashsanjeev97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, National Institute Of Ayurveda, Jaipur  Approved 
Institutional Ethics Committee, National Institute Of Ayurveda, Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: GRIVASTAMBAH/GRIVAHUNDANAM (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Both Marma cikitsa and Transcutaneous Electrical Nerve Stimulation (Procedure Reference: Joshi S.K. (2010), Marma Science and Principles of Marma Therapy (1st edition), Vani Publications Delhi, ISBN no. 81-89221-64-7, 46 and Fishbain, D.A., et al., Transcutaneous electrical nerve stimulation (TENS) treatment outcome in long-term users. Clin J Pain, 1996. 12(3): p. 201- 14., Procedure details: Both Marma cikitsa & Transcutaneous Electrical Nerve Stimulation will be performed for the patients. Initially Marma cikitsa is given then followed by Physiotherapy. After 1 week strengthening exercises & stretching exercises are advised. The progress will be noted in the specially prepared case sheet. The observations will be analyzed on the basis of assessment parameters ( Subjective & Objective) critically & clinically on 1st day, 8th day & 15th day. Finally results will be statically analysed.)
2Comparator ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: Joshi S.K. (2010), Marma Science and Principles of Marma Therapy (1st edition), Vani Publications Delhi, ISBN no. 81-89221-64-7, 46., Procedure details: The Marma cikitsa will be performed in which the following marmas will be manipulated : Amsa,Krkatika,Kurpara,Manibandha,Kshipra. Each Marma is stimulated in sync with the rhythm of respiration, which typically happens around 18 times per minute. The treatment will follow with 2 sittings each day with an interval of at least 2 hours for 2 weeks. The marma points are stimulated by gentle pressing & releasing for 15 to 20 times. After 1 week, strengthening exercises & stretching exercises are advised. )
3Comparator Arm (Non Ayurveda)-Transcutaneous Electrical Nerve Stimulation Transcutaneous Electrical Nerve Stimulation will be performed for the patients for 2 weeks. TENS is given for 10 minutes at 100Hz each day for 2 weeks. After 1 week strengthening exercises and stretching exercises are advised.
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Degenerative changes in the X-Ray
Reduced range of Motion
Pain in the cervical region
Patients free from systemic illness.
 
 
ExclusionCriteria 
Details  Not willing to undergo trial.
Inflammatory arthritis affecting the cervical region.
Spinal fractures.
Radiating pain.
Injury due to trauma.
Non mechanical injury.
Patient suffering from chronic illness like TB.
Uncontrolled DM.
Tumor or infection involving cervical spine
Cervical myelopathy
Contraindication of TENS. (pacemaker, pregnancy, open wound, seizure, DVT)
Recent surgery in the cervical region or spine. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in score of Visual Analogue Scale
 
1 month
 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Functional mobility of neck.
 
1 month 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   04/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Cervical spondylosis, marked by degenerative transformations within the cervical spine, such as pseudarthrosis, osteoarthritis affecting the apophyseal joints and disc degeneration, is extremely common. Most people with spondylotic changes of the cervical spine on radiographic imaging remain asymptomatic, with 25% of individuals under the age of 40, 50% of individuals over the age of 40, and 85% of individuals over the age of 60 showing some evidence of degenerative changes.Three overlapping syndromes can result from spondylitic osteophytic neural or vascular encroachment: nerve root compression (radiculopathy), spinal cord compression (myelopathy), and vertebral artery compression. The cause is unknown but may be accelerated by trauma, overuse, or genetic predisposition


MARMA CHIKITSA:

Marma points are the junction of five anatomical structures i.e. Mamsa (muscle), Sira (vessels), Snayu (ligament and nerve), Asthi (bone), and Sandhi (joints). Stimulation of Marma points optimises Prana Vayu and maintains equilibrium of Doshas.

Marmas serve as crucial energy points for prana flow. Marma chikitsa offers a natural, non- invasive, and effective healing approach by stimulating organs and systems instantly and permanently. This method can be applied anywhere, anytime, without relying on medication. The symptoms of Vata Vyadhi (various neurological and musculoskeletal disorders) are Sankocha (narrowing or degeneration), Parva Stambha (stiffness in joints), Asthibhed (pain in bones), Spandana and Gatrasuptta (numbness), which can be co related with cervical spondylosis.

PHYSIOTHERAPY:

Physiotherapy is a health care profession concerned with human function and movement and maximising physical potential. It is concerned with identifying and maximising quality of life and movement potential within the spheres of promotion, prevention, treatment/ intervention and rehabilitation.Transcutaneous electrical nerve stimulation (TENS) involves applying a low voltage electrical current through the skin via surface electrodes to help manage pain, practice noted in classical medicine as early as the first century. Initially introduced as a screening tool for spinal cord stimulation in clinical settings, TENS soon revealed its efficiency in alleviating pain solely through skin stimulation.




 
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