Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis

Phase 2

Active, not recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Drug: Placebo; Drug: Dextrose prolotherapy (DPT)

• Registration Number: NCT05160532
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this research is to learn more about treating Symptomatic Knee Osteoarthritis (OA) with an ultrasound-guided hypertonic dextrose injection. Researchers would like to determine best practice for injection frequency and effectiveness of the dextrose injection for symptomatic knee OA.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-02
• Study First Posted: 2021-12-16
• Study Start: 2022-04-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Diagnosis of knee OA by clinical criteria (American College of Rheumatology).
• Identification of knee osteoarthritis by a radiologist on an existing knee radiograph obtained within 3 years of enrollment.
• Moderate to severe knee pain for at least 3 months, defined as a score of ≥ 4 (on a 0-10 point numeric rating scale) in response to the question "What is the average level of your left/right knee pain in the past 3 months?".

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Exclusion Criteria

• Pregnancy.
• Diabetes.
• Anticoagulation therapy.
• History of total knee replacement.
• Prior knee prolotherapy or other regenerative product.
• Any knee injection within 3 months.
• Inflammatory (RA, gout, pseudogout etc.) or postinfectious knee arthritis.
• Daily use of opioid medication.
• Allergy or intolerance to study medication, corn allergy.
• Body mass index (BMI) greater than 40 kg/m^2.
• Comorbidity severe enough to prevent participation in the study protocol.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Four injections of placebo	Placebo	Subjects will receive four placebo intraarticular knee injections under ultrasound guidance. A placebo looks exactly like the study drug, but it contains no active ingredient.
One injection of DPT and three injections of placebo	Placebo	Subjects will receive one intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by three intraarticular knee injections of placebo under ultrasound guidance.
Two injections of DPT and two injections of placebo	Placebo	Subjects will receive two intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by two intraarticular knee injections of placebo under ultrasound guidance.
Two injections of DPT and two injections of placebo	Dextrose prolotherapy (DPT)	Subjects will receive two intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by two intraarticular knee injections of placebo under ultrasound guidance.
Four injections of DPT	Dextrose prolotherapy (DPT)	Subjects will receive four intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT).
One injection of DPT and three injections of placebo	Dextrose prolotherapy (DPT)	Subjects will receive one intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by three intraarticular knee injections of placebo under ultrasound guidance.

Primary Outcome Measures

Name	Time	Method
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Baseline, 4 weeks, 8 weeks, 16 weeks, 26 weeks, and 52 weeks	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) disease-specific tool used to measure physical function, pain, and stiffness in individuals with knee OA. Total scores range from 0-100, with higher scores indicating worse outcome.

Secondary Outcome Measures

Name	Time	Method
Change in pain	Baseline, 4 weeks, 8 weeks, 16 weeks, 26 weeks, and 52 weeks	Measured using a visual analogue scale with 0 = no pain and 10=worst pain.

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States