A clinical trial to compare the effects of Intraarticular hylan g-f 20, dextrose, ozone and combination of dextrose & ozone in patients with osteoarthritis knee.

Phase 4

Recruiting

• Conditions: Knee osteoarthritis

• Registration Number: CTRI/2017/06/008734
• Lead Sponsor: ESI Institute of Pain Management

Brief Summary

60patients with knee osteoarthritis will be randomly selected and will be divided equally into four groups- Group **D** will be treated with dextrose, Group **H** by high molecularweight hylan G-F 20, Group **O** by ozone, Group **C** by combination of dextrose and ozone both. High molecular hylan G-F 20 will be given once where as dextrose and ozone will be given once per week for 5 weeks. Neumeric Rating Scale (NRS) score and Western Ontario McMaster University Arthritis index (WOMAC) score will be assessed before and twomonths after the procedure. 2 months after the completion of the course astanding X-Ray of affected knee will be done again. Finally pre treatment andpost treatment scores and joint space will be compared. Resultswill be computed and analysed by appropriate statistical methods. Theobjective of the study was to compare the effect of four treatmentprotocols on pain and function by comparison of NRS scale and WOMAC assessment scale respectively.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-03
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Pain in the knee Kellgren – Lawrence grade I,II,III on PA knee radiograph, and grade IV not willing to surgery Age 50 to 75 years.
• Any THREE of the following: a)Less than 30 minutes of morning stiffness.
• b)Crepitus on active movement.
• c)Bony tenderness.
• d)Bony enlargement.
• e)No palpable warmth of synovium.

Exclusion Criteria

• Systemic disease On anticoagulants Knee pain/ swelling due to inflammation, infection etc.
• Previous intra articular injection.
• Use of opioid analgesics.
• Patients taking opioid analgesics.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain in Numeric Rating Scale Score	Day 0 and 2 months after the completion of treatment course

Secondary Outcome Measures

Name	Time	Method
function by Western Ontario and McMaster University Arthritis Index (WOMAC) score	day 0 and 2 months after completion of treatment course
Joint space in standing Xray of affected knee joint	day 0 and 2 months after the completion of treatment course

Trial Locations

Locations (1)

ESI Hospital, Sealdah; 🇮🇳 Kolkata, WEST BENGAL, India

ESI Hospital, Sealdah

🇮🇳Kolkata, WEST BENGAL, India

Dr Subrata Goswami

Principal investigator

9830430430

drsgoswami@gmail.com