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CTRI Number  CTRI/2020/05/025109 [Registered on: 11/05/2020] Trial Registered Prospectively
Last Modified On: 19/04/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Management of Tennis Elbow 
Scientific Title of Study   COMPARATIVE EFFICACY OF AGNIKARMA AND THERAPEUTIC ULTRASOUND IN THE MANAGEMENT OF TENNIS ELBOW 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IEC-AIMS-2019-AYUR-164  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr SREELEKSHMI R 
Designation  PG Scholar 
Affiliation  AMRITA SCHOOL OF AYURVEDA,AMRITAPURI,AMRITA VISHWAVIDYAPEETAM,INDIA 
Address  Department of Shalya Tantra (Surgery), Amrita School of Ayurveda, Amritapuri, Amrita Vishwavidyapeetham, India.
Department of Shalya Tantra (Surgery), Amrita School of Ayurveda, Amritapuri, Amrita Vishwavidyapeetham, India.
Kollam
KERALA
690525
India 
Phone  8547367396  
Fax  04762899681  
Email  sreelekshmisarayu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr RABINARAYAN TRIPATHY 
Designation  PROFESSOR AND HOD 
Affiliation  AMRITA SCHOOL OF AYURVEDA,AMRITAPURI,AMRITA VISHWAVIDYAPEETAM,INDIA 
Address  Department of Shalya Tantra (Surgery), Amrita School of Ayurveda, Amritapuri, Amrita Vishwavidyapeetham, India.
Department of Shalya Tantra (Surgery), Amrita School of Ayurveda, Amritapuri, Amrita Vishwavidyapeetham, India.
Kollam
KERALA
690525
India 
Phone  8129292391  
Fax  04762899681  
Email  rabinarayan@ay.amrita.edu  
 
Details of Contact Person
Public Query
 
Name  Dr SREELEKSHMI R 
Designation  PG Scholar 
Affiliation  AMRITA SCHOOL OF AYURVEDA,AMRITAPURI,AMRITA VISHWAVIDYAPEETAM,INDIA 
Address  Department of Shalya Tantra (Surgery), Amrita School of Ayurveda, Amritapuri, Amrita Vishwavidyapeetham, India.
Department of Shalya Tantra (Surgery), Amrita School of Ayurveda, Amritapuri, Amrita Vishwavidyapeetham, India.
Kollam
KERALA
690525
India 
Phone  8547367396  
Fax  04762899681  
Email  sreelekshmisarayu@gmail.com  
 
Source of Monetary or Material Support  
AMRITA SCHOOL OF AYURVEDA,AMRITAPURI AMRITA VISHWAVIDYAPEETHAM,INDIA 
 
Primary Sponsor  
Name  Dr SREELEKSHMI R 
Address  Department of Shalya Tantra (Surgery), Amrita School of Ayurveda, Amritapuri, Amrita Vishwavidyapeetham, India.  
Type of Sponsor  Other [INVESTIGATOR HIMSELF] 
 
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 SREELEKSHMI R  Amrita Ayurveda Hospital  DEPARTMENT OF SHALYA TANTRA(SURGERY) AMRITA SCHOOL OF AYURVEDA,AMRITAPURI AMRITA VISHWA VIDYAPEETHAM,INDIA
Kollam
KERALA 
8547367396
04762899681
sreelekshmisarayu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,AIMS,Kochi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z40-Z53||Encounters for other specific health care,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AGNIKARMA(THERMAL CAUTERISATION) IN THE MANAGEMENT OF TENNIS ELBOW  Agnikarma will be done with Red-hot Panchadhathu shalaka,2.5cm circumferential area around most tender point 0.5 cm apart in 1 sec for each prick and shalaka withdrawn quickly.Immediately after this, the area will be wiped with Kumari pulp.Paste of Madhu and Ghritha will be applied to the site. Two sittings of Agnikarma will be repeated with a gap of 7days  
Comparator Agent  THERAPEUTIC ULTRASOUND IN THE MANAGEMENT OF TENNIS ELBOW.  Apply Continuous Therapeutic Ultrasound of intensity 1.5W/sq.cm, Frequency 1MHz for 5 min.Procedure repeated for 15 days  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients between 20 yrs - 60yrs of age.
2. Select irrespective of sex, religion, Occupation and socioeconomic status.
3.Diagnose on the basis of signs and symptoms found in Tennis elbow.

 
 
ExclusionCriteria 
Details  1.Patients diagnosed with joint disorders (viz. RA, OA, GA of elbow joint), Tuberculosis, Diabetes or associated some other constitutional disorders.
2.Patient diagnosed with Malignant tumors, senile osteoporosis etc in and around the elbow.
3.Patient with a history of corticosteroid injection in last one month
4.Patient contraindicated for Agnikarma.
5.Patient contraindicated for Therapeutic ultrasound
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Pain –VAS
2.Pain and Functional Disability –PRTEE
3.Tenderness – Grade 0 to Grade 4
 
Periodical clinical assessment done in 0, 8,15,30,90 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Pain –VAS
2.Pain and Functional Disability –PRTEE 3.Tenderness – Grade 0 to Grade 4
 
Periodical clinical assessment done in 0, 8,15,30,90 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   Phase 3 
Date of First Enrollment (India)   14/05/2020 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
PROPOSED TITLE – COMPARATIVE EFFICACY OF AGNIKARMA AND THERAPEUTIC ULTRASOUND IN THE MANAGEMENT OF TENNIS ELBOW.
 
ABSTRACT: Tennis Elbow is a very common condition affecting mainly middle-aged patients. It is relatively common with an annual incidence in the general population of 1% to 3%.In earlier days it is often reported in tennis players but in present-day practice, it is known to affect painters, plumbers, carpenters, drivers,  housewives, software professionals, etc. Tennis Elbow is a condition characterized by pain and tenderness at the lateral epicondyle of the humerus due to non-specific inflammation at the origin of the extensor muscles of the forearm. Various treatment modalities like NSAID, Corticosteroid injection, Counter bracing, Physiotherapy, surgery, etc available in Tennis Elbow. But many they have its limitations.  Continuous use of NSAIDS produces side effects such as nausea, somnolence, gastrointestinal disorders increase the risk of cardiovascular events, etc. Corticosteroid injections give only short term relief and produce high recurrence after treatment.  Prolonged use of Epicondylar counter brace produces secondary nerve problem. Surgery is costly and can also lead to complications like the postero-lateral instability of the elbow joint. Agnikarma is a popular para-surgical procedure in Ayurveda in which thermal energy/ heat is utilized.  

Literature shows Therapeutic Ultrasound is also effective in this condition. It needs to focus on to find out the most effective treatment modality which yields the best result for Tennis Elbow. The proposed study is designed to evaluate the efficacy of Agnikarma with Therapeutic Ultrasound along with exercise in the management of Tennis Elbow. 

METHODS:  The study is proposed to be conducted in Amrita School of Ayurveda, Amritapuri. Patients will be screened based on the inclusion and exclusion criteria. Patients fit to the inclusion and exclusion criteria will be selected for the clinical trial .The 30 patients will be alternatively allocated to two groups, Group A and Group B .Group A patients will be first subjected to one sitting of Agnikarma with Red-hot Panchadhathu shalaka , 2.5cm circumferential area around most tender point 0.5 cm apart in 1 sec for each prick and shalaka withdrawn quickly. Three sittings of Agnikarma will be repeated with a gap of 7 days. And in Group B, apply Continuous Therapeutic Ultrasound of intensity 1.5W/sq.cm, Frequency 1 MHz for 5 min. on the affected part. Procedure repeated for 15 days. Pain will be assessed with VAS, Pain and Functional Disability will be assessed PRTEE and Tenderness – Grade 0 to Grade 4.The follow up and assessment will be done on 0, 8,15,30 and on 90th  day and the data will be properly recorded for statistical analysis . Paired t test, Students t test will be done for proper statistical analysis and interpretation. 

ï‚· Total Estimated cost: ₹.10000/- 
 
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