A comparative study to determine the safety and efficacy of Autologous Human Platelet Lysate (HPL)in treatment of Lateral Epicondylitis (Tennis Elbow)

Phase 1/2

Completed

• Conditions: Lateral Epicondylitis (Tennis Elbow)

• Registration Number: CTRI/2012/04/002611
• Lead Sponsor: KASIAK RESEARCH PRIVATE LIMITED

Brief Summary

This is a multicentre, openlabel, randomized,  pilot study to evaluate safety and efficacy of humanPlatelet Lysate (HPL) in subjects with Lateral Epicondylitis (Tennis Elbow). The study is being conducted in 2 centers inIndia. The primary end points are Visual Analog Score(VAS) and Patient rated tennis elbow evaluation (PRTEE) score. The secondaryendpoint is improvement in ultrasonography form randomization to End of study.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-20
• Last Update Posted: 2013-10-04

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Subjects with clinical diagnosis of tennis elbow within the last 3 months 2.Subjects both male and female, aged 18-60 years (both inclusive) 3.Subjects who are willing to give informed consent and adhere to the study protocol.

Exclusion Criteria

• 1.Subjects aged less than 18 and more than 60 years 2.Subjects with autoimmune diseases 3.Subjects with immuno-compromised system 4.Subjects on Anti-coagulant therapy or blood thinning medicines like Aspirin 5.Subjects taking concomitant therapy that might interfere with the study results in investigators opinion or who had concomitant other injury of the tennis elbow tendons.
• 6.Subjects who have received treatment with corticosteroid injections within the last 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3. All the above questionnaires are externally validated clinical outcome measures that rate elbow pain	End of study - 3 Months
1. Visual Analog Score (VAS) and Patient rated tennis elbow evaluation (PRTEE) score: To evaluate the effect of HPL on Pain Scores.	End of study - 3 Months
2. The American Shoulder and Elbow Society score – To evaluate the effect of HPL on pain, function, range of motion, strength and patient satisfaction on various numerical scales.	End of study - 3 Months

Secondary Outcome Measures

Name	Time	Method
Ultrasonography	End of study - 3 Months

Trial Locations

Locations (2)

Dr Anant Joshi’s Clinic; 🇮🇳 Mumbai, MAHARASHTRA, India

Hillway Clinic; 🇮🇳 Mumbai, MAHARASHTRA, India

Dr Anant Joshi’s Clinic

🇮🇳Mumbai, MAHARASHTRA, India

Dr Anant Joshi

Principal investigator

02224143240

asminst@yahoo.com