Changes in Cytokine Levels After Dextrose Injection in Stage IV Knee Osteoarthritis
- Conditions
- Osteoarthritis, Knee
- Interventions
- Drug: Aspiration 0Drug: Dextrose 0Drug: Aspiration 1Drug: Dextrose 1
- Registration Number
- NCT03400631
- Lead Sponsor
- Fisiatria y Traumatología
- Brief Summary
Twenty participants with severe arthritis will be enrolled. For the first week participants will either be injected with dextrose or just have fluid withdrawn for testing. The remaining participants will be given dextrose injection at the end of the week. After one week dextrose injections will be given at one, two, three, four, five, and six months. Fluid will be withdrawn from the knee at time zero, one week, and three months. The hypothesis is that dextrose injection will cause a change in proteins in the knee consistent with improved repair signals, along with improving knee pain and function. .
- Detailed Description
Participants with stage IV knee osteoarthritis will be evaluated for eligibility and randomized 1 to 1 using an Internet randomization method to ensure random allocation.
At time zero all participants will receive aspiration of their knees from the suprapatellar pouch of 5.5 mL of synovial fluid for cytokine analysis. After that 10 of the participants will receive injection of 10 mL of 12.5% dextrose. The other 10 will receive no injection after aspiration. Pain levels will be measured at time zero, 15 minutes, two hours and 48 hours after aspiration with or without injection to gather information about the time course of analgesia.
At one week all participants will receive aspiration of 2.0 mL from the suprapatellar pouch for cytokine analysis, followed by injection of the remaining 10 participants with dextrose 12.5%. Pain levels will be measured at the same time intervals to complete evaluation of dextrose analgesia.
After two weeks injections will be open label with 10 mills of dextrose 12 and have percent injected at one, two, three, four, five, and six months. At the three month. Another 2 mL of synovial fluid will be sent to the laboratory for cytokine analysis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Knee pain for at least 6 months.
- Clinically diagnosed knee osteoarthritis.
- Weight-bearing radiograph consistent with high-grade medial compartment cartilage loss (Kellgren-Lawrence Grading Scale level IV).
- Confirmation of exposed subchondral bone by high-resolution knee ultrasonography.
- Anticoagulation therapy.
- Inflammatory or post-infectious knee arthritis.
- Systemic inflammatory conditions.
- Knee flexion of less than 100 degrees.
- Knee extension of less than 165 degrees.
- Any Valgus
- Varus more than 15 degrees.
- Any knee injection in the past 3 months.
- BMI more than 40
- Gross synovial folds on ultrasound
- Elevation of sed rate, C reactive protein, rheumatoid factor or antinuclear antibody.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dextrose 0. Aspiration 1 week. Aspiration 1 Dextrose injection given at time 0, at 1 week aspiration only, and then open label injection of dextrose at 0, 1, 2, 3, 4, 5, and 6 months. Aspiration 0. Dextrose 1 week. Aspiration 0 Aspiration only at time 0. Dextrose injection given at 1 week, and then open label injection of dextrose at 0, 1, 2, 3, 4, 5, and 6 months. Aspiration 0. Dextrose 1 week. Dextrose 1 Aspiration only at time 0. Dextrose injection given at 1 week, and then open label injection of dextrose at 0, 1, 2, 3, 4, 5, and 6 months. Dextrose 0. Aspiration 1 week. Dextrose 0 Dextrose injection given at time 0, at 1 week aspiration only, and then open label injection of dextrose at 0, 1, 2, 3, 4, 5, and 6 months.
- Primary Outcome Measures
Name Time Method Short term change in cytokine levels Obtained at baseline and 1 week Change in cytokine levels from baseline to 1 week
Long term change in cytokine levels Obtained at baseline and 3 months Change in cytokine levels from baseline to 3 months
- Secondary Outcome Measures
Name Time Method Post Injection Short Term Pain Course 0, 15 minutes, 2 hours, and 48 hours after time 0 and 1 week injections Numerical rating scale (NRS) 0-10 pain score measured after time 0 and 1 week injections
WOMAC score Obtained at baseline, 3 and 6 months. Western Ontario and McMaster Universities Arthritis Index normalized to 100
Trial Locations
- Locations (1)
Gaston Topol, M.D.. Private Office
🇦🇷Rosario, Santa Fe, Argentina