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Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Placebo

Dextrose prolotherapy (DPT)

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Mayo Clinic in ArizonaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Four injections of placebo

One injection of DPT and three injections of placebo

Two injections of DPT and two injections of placebo

Four injections of DPT

Arm 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.

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.

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.

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

Outcomes

Primary Outcome Measures

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

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 Outcome Measures

Change in pain

Measured using a visual analogue scale with 0 = no pain and 10=worst pain.

Full Information

NCT ID

NCT05160532

First Posted

December 2, 2021

Last Updated

May 16, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT05160532

Brief Title

Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis

Official Title

Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 10, 2022 (Actual)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Four injections of placebo

Arm Type

Placebo Comparator

Arm 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.

Arm Title

One injection of DPT and three injections of placebo

Arm Type

Experimental

Arm Description

Arm Title

Two injections of DPT and two injections of placebo

Arm Type

Experimental

Arm 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.

Arm Title

Four injections of DPT

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

5ml of normal saline (NS)

Intervention Type

Drug

Intervention Name(s)

Dextrose prolotherapy (DPT)

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Description

Time Frame

Baseline, 4 weeks, 8 weeks, 16 weeks, 26 weeks, and 52 weeks

Secondary Outcome Measure Information:

Title

Change in pain

Description

Measured using a visual analogue scale with 0 = no pain and 10=worst pain.

Time Frame

Baseline, 4 weeks, 8 weeks, 16 weeks, 26 weeks, and 52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Patchett, DO

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Arizona

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85260

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Katelyn Valdez, MBA

Phone

480-301-6542

valdez.katelyn@mayo.edu

First Name & Middle Initial & Last Name & Degree

David Patchett, DO

Phone

480-860-4800

patchett.david@mayo.edu

12. IPD Sharing Statement

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis

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