Dextrose Prolotherapy

Overview

About this study

The proposed randomized controlled trial (RCT) for individuals with symptomatic knee OA is innovative. No trial has examined the optimal dosing interval for ultrasound guided dextrose prolotherapy intraarticular knee injections. This will give guidance to practitioners on the best frequency of dextrose prolotherapy to achieve symptomatic and functional improvements in knee OA patients. It also could give guidance to future studies of other regenerative products such as PRP for symptomatic knee OA and utilize DPT as the comparator treatment in a matched protocol.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Mankato, Minn. Mayo Clinic principal investigator Wade Johnson, D.O.	Closed for enrollment	Contact information: Hannah Henderson CCRP (480) 301-6091 Henderson.Hannah2@mayo.edu
La Crosse, Wis. Mayo Clinic principal investigator Jacob Erickson, D.O.	Closed for enrollment	Contact information: Hannah Henderson CCRP (480) 301-6091 Henderson.Hannah2@mayo.edu
Eau Claire, Wis. Mayo Clinic principal investigator Lang Jacobson, M.D.	Closed for enrollment	Contact information: Hannah Henderson CCRP (480) 301-6091 Henderson.Hannah2@mayo.edu
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator David Patchett, D.O.	Closed for enrollment	Contact information: Hannah Henderson CCRP (480) 301-6091 Henderson.Hannah2@mayo.edu

Mayo Clinic Location

Status

Contact

Mankato, Minn.

Mayo Clinic principal investigator

Wade Johnson, D.O.

Closed for enrollment

Contact information:

Hannah Henderson CCRP

(480) 301-6091

Henderson.Hannah2@mayo.edu

La Crosse, Wis.

Mayo Clinic principal investigator

Jacob Erickson, D.O.

Closed for enrollment

Contact information:

Hannah Henderson CCRP

(480) 301-6091

Henderson.Hannah2@mayo.edu

Eau Claire, Wis.

Mayo Clinic principal investigator

Lang Jacobson, M.D.

Closed for enrollment

Contact information:

Hannah Henderson CCRP

(480) 301-6091

Henderson.Hannah2@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

David Patchett, D.O.

Closed for enrollment

Contact information:

Hannah Henderson CCRP

(480) 301-6091

Henderson.Hannah2@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials