Changes in Cytokine Levels After Dextrose Injection in Stage IV Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

Changes in Cytokines After Masked Intraarticular Injection of Dextrose or Aspiration Only in Stage IV Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400631
• Other study ID #: AAFOYT
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: November 23, 2021

Study information

• Verified date: August 2022
• Source: Fisiatria y Traumatología
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 For the first week participants will either be injected with dextrose or just have fluid withdrawn for testing.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 Fluid will be withdrawn from the knee at time zero, one week, and three months.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. .

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 23, 2021
• Est. primary completion date: November 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Dextrose 0
Dextrose injection at time 0
• Aspiration 0
Aspiration only at time 0
• Dextrose 1
Dextrose injection at week 1
• Aspiration 1
Aspiration only at week 1

Locations

Country	Name	City	State
Argentina	Gaston Topol, M.D.. Private Office	Rosario	Santa Fe

Sponsors (2)

Lead Sponsor	Collaborator
Fisiatria y Traumatología	American Association of Orthopaedic Medicine

Country where clinical trial is conducted

Argentina, 

References & Publications (2)

Sit RW, Chung VCh, Reeves KD, Rabago D, Chan KK, Chan DC, Wu X, Ho RS, Wong SY. Hypertonic dextrose injections (prolotherapy) in the treatment of symptomatic knee osteoarthritis: A systematic review and meta-analysis. Sci Rep. 2016 May 5;6:25247. doi: 10.1038/srep25247. Review. Erratum in: Sci Rep. 2017 Apr 07;7:45879. — View Citation

Topol GA, Podesta LA, Reeves KD, Giraldo MM, Johnson LL, Grasso R, Jamín A, Clark T, Rabago D. Chondrogenic Effect of Intra-articular Hypertonic-Dextrose (Prolotherapy) in Severe Knee Osteoarthritis. PM R. 2016 Nov;8(11):1072-1082. doi: 10.1016/j.pmrj.2016.03.008. Epub 2016 Apr 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short term change in cytokine levels	Change in cytokine levels from baseline to 1 week	Obtained at baseline and 1 week
Primary	Long term change in cytokine levels	Change in cytokine levels from baseline to 3 months	Obtained at baseline and 3 months
Secondary	Post Injection Short Term Pain Course	Numerical rating scale (NRS) 0-10 pain score measured after time 0 and 1 week injections	0, 15 minutes, 2 hours, and 48 hours after time 0 and 1 week injections
Secondary	WOMAC score	Western Ontario and McMaster Universities Arthritis Index normalized to 100	Obtained at baseline, 3 and 6 months.