Management of Tennis Elbow

Phase 3

Not yet recruiting

• Conditions: Encounters for other specific health care,

• Registration Number: CTRI/2020/05/025109
• Lead Sponsor: Dr SREELEKSHMI R

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shalaka , 2.5cm circumferential area around most tender point 0.5 cm apart in 1 sec for each prick and shalaka withdrawn quickly.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/-

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-04-19
• Study Start: 2020-05-14

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Pain –VAS	Periodical clinical assessment done in 0, 8,15,30,90 days
2.Pain and Functional Disability –PRTEE	Periodical clinical assessment done in 0, 8,15,30,90 days
3.Tenderness – Grade 0 to Grade 4	Periodical clinical assessment done in 0, 8,15,30,90 days

Secondary Outcome Measures

Name	Time	Method
1. Pain –VAS	2.Pain and Functional Disability –PRTEE 3.Tenderness – Grade 0 to Grade 4

Trial Locations

Locations (1)

Amrita Ayurveda Hospital; 🇮🇳 Kollam, KERALA, India

Amrita Ayurveda Hospital

🇮🇳Kollam, KERALA, India

Dr SREELEKSHMI R

Principal investigator

8547367396

sreelekshmisarayu@gmail.com