| 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 |
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Type of Study
|
Ayurveda Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
A Study Comparing the Effectiveness of Marma Chikitsa and TENS Therapy in Cervical Spondylosis. |
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Scientific Title of Study
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A Randomized Comparative Clinical Study for the Efficacy of Marma Chikitsa and Transcutaneous Electrical Nerve Stimulation (TENS) Modality in the Management of Cervical Spondylosis
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| Trial Acronym |
NIL |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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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 |
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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 |
|
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Source of Monetary or Material Support
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| National Institute Of Ayurveda, Deemed University, Jaipur, Rajasthan, India, 302002 |
|
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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 |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| 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 |
|
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Details of Ethics Committee
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| 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 |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: GRIVASTAMBAH/GRIVAHUNDANAMÂ (KEVALAVATA), |
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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.)
| | 2 | Comparator Arm | Procedure | - | marmacikitsA, मरà¥à¤®à¤šà¤¿à¤•ितà¥à¤¸à¤¾ | (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.
)
| | 3 | Comparator 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.
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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. |
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Method of Generating Random Sequence
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Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
Changes in score of Visual Analogue Scale
|
1 month
|
|
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Secondary Outcome
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| Outcome |
TimePoints |
Improvement in Functional mobility of neck.
|
1 month |
|
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Target Sample Size
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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" |
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Phase of Trial
|
Phase 2 |
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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" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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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