Cold and Compression Post TKA
The purpose of this study is to compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups pre-surgically, daily after surgery for 14 days, then weekly after surgery for 3 months, and at 6 months post-surgery.
| Condition(s) | Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The purpose of this study is to compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups pre-surgically, daily after surgery for 14 days, then weekly after surgery for 3 months, and at 6 months post-surgery. |
| Who can participate | Inclusion Criteria: 1. Aged 50 yr or older 2. Patient of Dr. Howard Hirsch or Dr. Vinod Dasa scheduled for total knee arthroplasty (knee replacement) at Ochsner Kenner 3. Will receive outpatient physical therapy at OTW Driftwood for the entire post-op rehabilitation period 4. English speaking 5. Diagnosis of primary osteoarthritis Exclusion Criteria: 1. Chronic opioid use 2. Opioid use within the last 3 months 3. PCS score ≥ 30 4. Diagnosis of inflammatory disease process (i.e., gout, rheumatoid arthritis, systematic lupus erythematosus...) 5. Discharge to skilled nursing 6. Cold intolerance related to diseases, like Raynaud's 7. Significant vascular impairment in the affected region 8. Current clinical signs of inflammatory phlebitis, venous ulcers, or cellulitis 9. Significant risk facto |
| Ages | 50 Years |
| Sex | All |
| Lead sponsor | Ochsner Health System |
| Locations | New Orleans, Louisiana, United States |
| Start date | 2025-12-15 |
| NCT ID | NCT07023185 |
| Official listing | https://clinicaltrials.gov/study/NCT07023185 |