Effectiveness of ultrasound guided intra-articular injections of ozone and hyaluronic acid in improving pain and physical function in patients with primary osteoarthritis of knee: A randomized controlled trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Pain by VAS score
Study Overview
Brief Summary
Osteoarthritis of knee is a chronic degenerative disease with loss of joint surface cartilage leading to pain, stiffness and joint deformity affecting one’s day to day activities. The aim of my study is to compare the effectiveness of ultrasound guided intra-articular injections of ozone and hyaluronic acid in improving pain and physical function in patients with primary osteoarthritis of knee. The VAS and WOMAC will be measured before treatment and at the end of 1 month, 3 months and 6 months post intervention. Data will be analyzed using SPSS 25 version. For descriptive statistics, mean, standard deviation and percentage will be used. For comparing categorical data, Chi-square test will be used. Independent t-test will be used for comparison between the groups and mean changes from baseline within each group will be compared by repeated measures ANOVA test. A p-value < 0.05 will be considered statistically significant.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 40.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age group 40 to 65 years Patients with primary osteoarthritis of knee fulfilling 2016 ACR (American college of Rheumatology) revised criteria for early diagnosis of knee OA Osteoarthritis of knee with Kellgren-Lawrence grade 1,2 and 3 Willingness to participate in the study and comply with treatment and follow up VAS more than 4.
Exclusion Criteria
- •Recent knee trauma or knee surgery Knee infection Cognitive impairment Intra-articular injection of steroid/PRP/hyaluronic acid during past 3 months BMI more than 30 Bleeding disorders Recent myocardial infarction or stroke Uncontrolled systemic diseases.
Outcomes
Primary Outcomes
Pain by VAS score
Time Frame: Baseline, 1 month, 3 months and 6 months
Secondary Outcomes
- Physical function by WOMAC score(Baseline, 1 month, 3 months,)
Investigators
Yambem Hellena Devi
Regional Institute of Medical Sciences, Imphal, Manipur