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Completed

NCT Number: NCT05160532

Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis

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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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85260, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Use of oral steroids during the study period
  • Use of injectable steroids in the past 3 months or during the study period

Treatment and study plan

Placebo

Drug

5ml of normal saline (NS)

Dextrose prolotherapy (DPT)

Drug

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

Primary outcomes

  1. Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score

    Time frame: Baseline; Week 4; Week 8; Week 16; Week 26; Week 52

    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 0-96, with higher scores indicating worse outcome.

Secondary outcomes

  1. Change in Pain

    Time frame: Baseline, Week 4, Week 8, Week 16, Week 26, Week 52

    Measured using a visual analogue scale with 0 = no pain and 10=worst pain with higher scores indicating worse pain.

  2. Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score

    Time frame: Baseline, Week 4, Week 8, Week 16, Week 26, Week 52

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) disease-specific tool used to measure physical function in individuals with knee OA. Total scores range from 0-68, with higher scores indicating worse physical function.

  3. Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score

    Time frame: Baseline, Week 4, Week 8, Week 16, Week 26, Week 52

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) disease-specific tool used to measure stiffness in individuals with knee OA. Total scores range from 0-8, with higher scores indicating worse stiffness.

  4. Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score

    Time frame: Baseline, Week 4, Week 8, Week 16, Week 26, Week 52

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) disease-specific tool used to measure pain in individuals with knee OA. Total scores range from 0-20, with higher scores indicating worse pain.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 16, 2021
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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