Effects of Dextrose on Knee Osteoarthritis

Study Overview
=================
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.

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

Conditions
-----------------
Physical Activity, Functional Disturbance

Intervention / Treatment
-----------------
* Drug: dextrose
* Device: hyaluronic acid


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: hyaluronic acid combined dextrose group<br>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 | Drug: dextrose<br>* compare the therapeutic effects of hyaluronic acid combined dextrose injections with hyaluronic acid injections only to patients with knee osteoarthritis<br>* Other names: glucose water;Device: hyaluronic acid<br>* compare the therapeutic effects of hyaluronic acid combined dextrose injections with hyaluronic acid injections only to patients with knee osteoarthritis<br>|
| Placebo Comparator: hyaluronic acid group<br>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 | Device: hyaluronic acid<br>* compare the therapeutic effects of hyaluronic acid combined dextrose injections with hyaluronic acid injections only to patients with knee osteoarthritis<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
knee osteoarthritis, hyaluronic acid, dextrose, therapeutic effects