| CTRI Number |
CTRI/2025/06/088979 [Registered on: 17/06/2025] Trial Registered Prospectively |
| Last Modified On: |
16/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Agnikarma and Ultrasound therapy] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Neck Pain Management A Clinical Trial of Agni Karma and Ultrasound Therapy |
|
Scientific Title of Study
|
Randomized Controlled Trial of Agni Karma and Ultrasound Therapy in Managing Neck Disability |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vidhi Mutha |
| Designation |
Final year UG student |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune |
| Address |
Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9209386419 |
| Fax |
|
| Email |
vidhimutha141@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhijeet Shirkande |
| Designation |
Associate Professor |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune |
| Address |
Dr D Y Patil College of Ayurved and Research Centre Dravyaguna Vigyan Department Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9975253664 |
| Fax |
|
| Email |
drabhijitshirkande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhijeet Shirkande |
| Designation |
Associate Professor |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune |
| Address |
Dr D Y Patil College of Ayurved and Research Centre Dravyaguna Vigyan Department Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9975253664 |
| Fax |
|
| Email |
drabhijitshirkande@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil Vidhyapeeth Sant Tukaram Nagar Pimpri Pune 411018
Maharashtra India
|
|
|
Primary Sponsor
|
| Name |
Dr D Y Patil Vidyapeeth Pune |
| Address |
Dr D Y Patil Vidyapeeth Sant Tukaram Nagar Pimpri Pune 411018
Maharashtra India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhijeet Shirkande |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTER |
Kayachikitsa department
Pune
MAHARASHTRA |
9975253664
vidhimutha141@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr DYPCA and RC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: MANYASTAMBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushrut samhita Sutrasthana 12 adhyaya , Procedure details: Procedure Reference: Sushruta Samhita Sutrasthan Agnikarma is a unique para-surgical technique described in Ayurveda, used for managing musculoskeletal pain & chronic disorders. It involves the application of therapeutic heat using specially designed instruments to specific body points or areas., Procedure details: Agnikarma is a unique para-surgical technique described in Ayurveda, used for managing musculoskeletal pain & chronic disorders. It involves the application of therapeutic heat using specially designed instruments to specific body points or areas. Time duration is 1-2mins)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Ultrasound therapy | Ultrasound Therapy is one of the most important physical treatment modalities in Myofascial Trigger Point treatment which is used for heating deep tissues.It uses high-frequency sound waves typically 1–3 MHz that are transmitted into the body’s tissues using a transducer (a handheld device) and a coupling gel. Time duration is 5 mins. |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 25 years with pain intensity greater than equal to 4 on a 10 point scale |
|
| ExclusionCriteria |
| Details |
Severe medical conditions like cancer, neurological conditions. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce the neck pain in patients with chronic neck disability. |
Screening will be conducted on Day 0. The intervention/procedure will be administered on Days 1, 2, and 3. Clinical assessments will be performed on Day 0 (baseline) and on Day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Range of Motion (ROM) of the cervical spine, measured in degrees using a goniometer |
14 days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="3"
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
|
Neck disability is a common and debilitating condition affecting millions of individuals worldwide, resulting in significant pain, limited mobility, and reduced quality of life. Conventional treatments often provide limited relief, highlighting the need for alternative and complementary therapies. Agni Karma, an ancient Ayurvedic technique, and Ultrasound Therapy is one of the most important physical treatment modalities in Myofascial Trigger Point treatment which is used for heating deep tissues.However, their efficacy in addressing neck disability remains uncertain. This randomized controlled trial aims to investigate the comparative effectiveness of Agni Karma and Ultrasound Therapy in alleviating neck disability, exploring their potential as adjunctive therapies for this prevalent condition. |