Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Knee Osteoarthritis

Treatments: Drug: Dextrose prolotherapy (DPT); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05160532

21-008778

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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?".

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 4 patient groups, including a placebo group

Four injections of placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

One injection of DPT and three injections of placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Dextrose prolotherapy (DPT)

Two injections of DPT and two injections of placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Dextrose prolotherapy (DPT)

Four injections of DPT

Experimental group

Description:

Subjects will receive four intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT).

Treatment:

Drug: Dextrose prolotherapy (DPT)