Effects of Dextrose on Knee Osteoarthritis

Phase 4

• Conditions: Physical Activity; Functional Disturbance
• Interventions: Drug: dextrose; Device: hyaluronic acid

• Registration Number: NCT03238183
• Lead Sponsor: Taipei Medical University

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.

Study Timeline

• Study First Submitted: 2017-07-28
• Status Verified: 2017-08
• Study Start: 2017-08
• Study First Submitted QC: 2017-08-02
• Last Update Submitted: 2017-08-02
• Study First Posted: 2017-08-03
• Last Update Posted: 2017-08-03
• Primary Completion: 2019-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hyaluronic acid combined dextrose group	hyaluronic acid	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 group	hyaluronic acid	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
hyaluronic acid combined dextrose group	dextrose	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

Primary Outcome Measures

Name	Time	Method
physical activity-stair climbing time	changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection	stairs climbing
physical activity-chair rising time	changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection	chair rising
physical activity-on level walking time	changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection	10 meter walking

Secondary Outcome Measures

Name	Time	Method
functional performance	changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection	Western Ontario and McMaster Universities Osteoarthritis index
quality of life	changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection	Knee Injury and Osteoarthritis Outcome Score

Trial Locations

Locations (1)

Shin Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei, Taiwan