A clinical trial to compare the effect of two treatment modalities, needle tenotomy and shock wave therapy of common tendon origin in the treatment of tennis elbow

Not yet recruiting

• Conditions: Lateral epicondylitis,

• Registration Number: CTRI/2019/10/021781
• Lead Sponsor: Sreejith C

Brief Summary

This is a single blinded randomized controlled trial comparing the efficacy of ultrasound guided percutaneous needle tenotomy and extracorporeal shock wave therapy in reducing pain and functional disability in the management of lateral epicondylosis in 82 patients that will be conducted in  one center in India for 1 year of duration.The primary outcome measures will be Visual Analogue Scale, Patient Rated Tennis Elbow Evaluation  at 4 weeks, 12 weeks and 24 weeks.Secondary outcome measure will be Grip strength measured at 4 weeks, 12 weeks and 24 weeks

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-10-18
• Study Start: 2019-10-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

1.Diagnosed cases of resistant lateral epicondylosis 2.Pain severity with minimum score of 5 based on 10 scale VAS 3.Willingness to comply with treatment and follow up assessment.

Exclusion Criteria

1.Any recent febrile or infectious disease 2.History of any malignancy or autoimmune disease 3.Peripheral nerve injuries 4.Systemic illness including ischemic heart disease, HIV 5.Treatment with anticoagulant or anti-platelet within 10 days of procedure 6.Haemoglobin less than 10 g/dl 7.Pregnancy 8.Cardiac arrhythmia or pace makers 9.Received cortico steroid injection within the previous 12 weeks 10.Allergy to local anaesthetics.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Visual Analogue Scale (VAS) for pain	1.4 weeks, 12 weeks and 24 weeks | 2.4 weeks, 12 weeks and 24 weeks
2.Patent Rated Tennis Elbow Evaluation (PRTEE)	1.4 weeks, 12 weeks and 24 weeks | 2.4 weeks, 12 weeks and 24 weeks

Secondary Outcome Measures

Name	Time	Method
Grip strength	4 weeks, 12 weeks and 24 weeks

Trial Locations

Locations (1)

Regional Institute of Medical Sciences; 🇮🇳 West, MANIPUR, India

Regional Institute of Medical Sciences

🇮🇳West, MANIPUR, India

Sreejith C

Principal investigator

7907496573

sreec50@gmail.com