Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-10

Study Completion Date

2025-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Four injections of 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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

5ml of normal saline (NS)

One injection of DPT and three injections of 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.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

5ml of normal saline (NS)

Dextrose prolotherapy (DPT)

Intervention Type DRUG

25% dextrose, mixing 2.5ml of sterile water and 2.5ml of 50% dextrose.

Two injections of DPT and two injections of 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.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

5ml of normal saline (NS)

Dextrose prolotherapy (DPT)

Intervention Type DRUG

25% dextrose, mixing 2.5ml of sterile water and 2.5ml of 50% dextrose.

Four injections of DPT

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

Group Type EXPERIMENTAL

Dextrose prolotherapy (DPT)

Intervention Type DRUG

25% dextrose, mixing 2.5ml of sterile water and 2.5ml of 50% dextrose.

Interventions

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Placebo

5ml of normal saline (NS)

Intervention Type DRUG

Dextrose prolotherapy (DPT)

25% dextrose, mixing 2.5ml of sterile water and 2.5ml of 50% dextrose.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No