Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05160532

Enrollment

Registered

2021-12-16

Start date

2022-04-10

Completion date

2025-05-31

Last updated

2025-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

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.

Interventions

DRUGPlacebo

5ml of normal saline (NS)

DRUGDextrose prolotherapy (DPT)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026