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Clinical Trials/CTRI/2023/11/059765
CTRI/2023/11/059765
Recruiting
Phase 4

Comparison of the analgesic efficacy of combined peri-articular hypertonic dextrose prolotherapy, intra-articular Magnesium and Ozone (Dextrose Magnesium Ozone Therapy) with Intra articular Corticosteroid in the management of moderate-severe Osteoarthritis of the Knee: Randomized Double-Blind, Placebo-controlled Trial - NI

Sri Madhusudan Sai Institute of Medical Sciences and Research,0 sites0 target enrollmentTBD

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Sri Madhusudan Sai Institute of Medical Sciences and Research,
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Sri Madhusudan Sai Institute of Medical Sciences and Research,

Eligibility Criteria

Inclusion Criteria

  • Adult patients aged 40 years and above, who meet the American College of Rheumatology criteria for osteoarthritis (knee pain for most of the days of the previous month and osteophyte (s) at the joint line visible on X ray) 29, are willing to consent and have moderate\-severe OAK.
  • Clinical Severity: Patients should have a mean score of 1\.5 \- 3\.5 on WOMAC A sub score30, 31\.
  • Radiological Severity of Osteoarthritis of the knee is based on the criteria defined by Kellgren and Lawrence, which grades OAK into 0\-4 grades32\. This study will be including Grade 3 and Grade 4 Osteoarthritis of the knee

Exclusion Criteria

  • Participants unwilling to provide consent
  • Patients with mild OAK
  • Participants with known history of drug allergy to bupivacaine, corticosteroid or lidocaine
  • Patients on anticoagulant or antiplatelet medication
  • Patients who have had a myocardial infraction in the last 6 months
  • Patients with secondary OAK (gout, RA, Psoriasis) or generalized osteoarthritis
  • Patients who have received intra articular steroids into any joint within 3 months

Outcomes

Primary Outcomes

Not specified

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