Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Low Dose Radiation
: Test Arm
Dose- 0.5Gy x 6 sessions
Total Dose- 3Gy
Delivered on Alternate Days
Control Intervention1: Sham Radiation: Placebo
Schedule of Delivery- Alternate Days
To
Sponsors
All India Institute of Medical Sciences Mangalagiri
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age more than 50 years 2. Diagnosed case of knee OA according to ACR diagnostic criteria 3. Grade 2-3 Knee OA (according to Kellgren Lawrence grading) 4. Patient with pain VAS score more than including 50 and less than including 90 5. Patients willing to discontinue all pain medications except for rescue medications throughout screening, baseline, and the trial period 6. Written Informed Consent
Exclusion criteria
Exclusion criteria: 1. Previous irradiation to knee 2. Participants of other clinical trials 3. History of malignancy within last 5 years 4. History of knee or hip surgery in the past or scheduled for knee or hip surgery 5. Patients who had received systemic steroids or steroid injections within the last 2 months 6. BMI more than 39Kg/m2 7. History of diseases that may affect the Index Joint (Rheumatoid arthritis, SLE, etc.) 8. Patient with known psychiatric disorders which may render the patient ineligible to give an informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the OARSI-OMERACT response rates of Osteoarthritis of Knee following Low-Dose Radiotherapy at 3 months post radiationTimepoint: To assess the OARSI-OMERACT response rates of Osteoarthritis of Knee following Low-Dose Radiotherapy at 3 months post radiation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the OARSI-OMERACT response rates of Osteoarthritis of Knee following low-dose radiotherapy at 4 weeks and 6 months post radiation 2. To evaluate Pain using the VAS scores among the different groups at 4 weeks, 3 months and 6 months post radiation 3. To evaluate the functional outcome using the WOMAC score, at 4 weeks, 3 months and 6 months post radiation 4. To evaluate the PGA and PGIC scores at 4 weeks, 3 months and 6 months post radiation 5. To evaluate the changes in ESR and CRP values at 4 weeks, 3 months and 6 months post radiation 6. To evaluate the radiological changes post-radiation (MRI and X-ray) at 6 months 7. To evaluate the difference between the reirradiation rates between the two groupsTimepoint: 4 weeks 3 & 6 months | — |
Countries
India
Contacts
Public ContactDr Soorej Balan Kaliyath
All India Institute of Medical Sciences Manglalagiri
Outcome results
None listed