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
|
|
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
|
|
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.
 Total Estimated cost: ₹.10000/- |