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Effects of Dextrose on Knee Osteoarthritis

Primary Purpose

Physical Activity, Functional Disturbance

Status

Unknown status

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

dextrose

hyaluronic acid

About this trial

This is an interventional treatment trial for Physical Activity focused on measuring knee osteoarthritis, hyaluronic acid, dextrose, therapeutic effects

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

knee osteoarthritis with Kellgren/Lawrence grade II or III

Exclusion Criteria:

who have neurological deficit, such as stroke who have implant in knee

Sites / Locations

Shin Kong Wu Ho-Su Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

hyaluronic acid combined dextrose group

hyaluronic acid group

Arm Description

Hyaluronic acid (2 cc) combined 25% dextrose (3.5 cc 50% dextrose plus 3.5 cc 2% lidocaine) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined hyaluronic acid and dextrose injections to hyaluronic acid injections

Hyaluronic acid (2 cc) combined normal saline (3.5 cc normal saline plus 3.5 cc 2% lidocaine) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined hyaluronic acid and dextrose injections to hyaluronic acid injections

Outcomes

Primary Outcome Measures

physical activity-on level walking time

10 meter walking

physical activity-stair climbing time

stairs climbing

physical activity-chair rising time

chair rising

Secondary Outcome Measures

functional performance

Western Ontario and McMaster Universities Osteoarthritis index

quality of life

Knee Injury and Osteoarthritis Outcome Score

Full Information

NCT ID

NCT03238183

First Posted

July 28, 2017

Last Updated

August 2, 2017

Sponsor

Taipei Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03238183

Brief Title

Effects of Dextrose on Knee Osteoarthritis

Official Title

Additional Therapeutic Effects of Dextrose to Hyaluronic Acid on Knee Osteoarthritis: a Double Blind, Randomized-controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Unknown status

Study Start Date

August 2017 (Anticipated)

Primary Completion Date

July 2019 (Anticipated)

Study Completion Date

July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Taipei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ultrasound guided hyaluronic acid injection and hyaluronic acid combined dextrose injection to patients with knee osteoarthritis.

Detailed Description

A total of 106 patients will be collected. The participants will be randomized into two groups, including hyaluronic acid group and hyaluronic acid combined dextrose group. The hyaluronic acid group will receive 3 times of hyaluronic acid injection per week in three weeks; the hyaluronic acid combined dextrose group will receive 3 times of hyaluronic acid combined dextrose injection per week in three weeks. The pain, physical activity, and functional performance will be evaluated. All the evaluations will be re-evaluated at one week after injection, one month after injection, three months after injection, and six month after injection. Subjects and the evaluator will be both blinded to the group's classification during the whole course of study.

6. Conditions and Keywords

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

Physical Activity, Functional Disturbance

Keywords

knee osteoarthritis, hyaluronic acid, dextrose, therapeutic effects

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

hyaluronic acid combined dextrose group

Arm Type

Active Comparator

Arm Description

Arm Title

hyaluronic acid group

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

dextrose

Other Intervention Name(s)

glucose water

Intervention Description

compare the therapeutic effects of hyaluronic acid combined dextrose injections with hyaluronic acid injections only to patients with knee osteoarthritis

Intervention Type

Device

Intervention Name(s)

hyaluronic acid

Intervention Description

compare the therapeutic effects of hyaluronic acid combined dextrose injections with hyaluronic acid injections only to patients with knee osteoarthritis

Primary Outcome Measure Information:

Title

physical activity-on level walking time

Description

10 meter walking

Time Frame

changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection

Title

physical activity-stair climbing time

Description

stairs climbing

Time Frame

changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection

Title

physical activity-chair rising time

Description

chair rising

Time Frame

changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection

Secondary Outcome Measure Information:

Title

functional performance

Description

Western Ontario and McMaster Universities Osteoarthritis index

Time Frame

changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection

Title

quality of life

Description

Knee Injury and Osteoarthritis Outcome Score

Time Frame

changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: knee osteoarthritis with Kellgren/Lawrence grade II or III Exclusion Criteria: who have neurological deficit, such as stroke who have implant in knee

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ru-Lan Hsieh

Phone

228332211

M001052@ms.skh.org.tw

First Name & Middle Initial & Last Name or Official Title & Degree

Ru-Lan Hsieh

Phone

228332211

rulan@tmu.edu.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ru-Lan Hsieh

Organizational Affiliation

Shin Kong Wu Ho-Su Memorial Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shin Kong Wu Ho-Su Memorial Hospital

City

Taipei

ZIP/Postal Code

111-01

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35439521

Citation

Hsieh RL, Lee WC. Effects of Intra-articular Coinjections of Hyaluronic Acid and Hypertonic Dextrose on Knee Osteoarthritis: A Prospective, Randomized, Double-Blind Trial. Arch Phys Med Rehabil. 2022 Aug;103(8):1505-1514. doi: 10.1016/j.apmr.2022.04.001. Epub 2022 Apr 16.

Results Reference

derived

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Effects of Dextrose on Knee Osteoarthritis

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