Gaston Topol, M.D.. Private Office
Rosario, Santa Fe Province, CS2000CXP, Argentina
NCT Number: NCT03400631
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 For the first week participants will either be injected with dextrose or just have fluid withdrawn for testing.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 Fluid will be withdrawn from the knee at time zero, one week, and three months.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. .
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Notify Me21 year–75 year
All sexes
Interventional
Not applicable
Rosario, Santa Fe Province, CS2000CXP, Argentina
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dextrose injection at time 0
Aspiration only at time 0
Dextrose injection at week 1
Aspiration only at week 1
Time frame: Obtained at baseline and 1 week
Change in cytokine levels from baseline to 1 week
Time frame: Obtained at baseline and 3 months
Change in cytokine levels from baseline to 3 months
Time frame: 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
Time frame: Obtained at baseline, 3 and 6 months.
Western Ontario and McMaster Universities Arthritis Index normalized to 100
Fisiatria y Traumatología
Other
Changes in Cytokines After Masked Intraarticular Injection of Dextrose or Aspiration Only in Stage IV Knee Osteoarthritis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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