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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hyaluronic acid combined dextrose group | Active Comparator | 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 | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dextrose | Drug | compare the therapeutic effects of hyaluronic acid combined dextrose injections with hyaluronic acid injections only to patients with knee osteoarthritis |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ru-Lan Hsieh | Contact | 228332211 | M001052@ms.skh.org.tw | |
| Ru-Lan Hsieh | Contact | 228332211 | rulan@tmu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Ru-Lan Hsieh | Shin Kong Wu Ho-Su Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shin Kong Wu Ho-Su Memorial Hospital | Taipei | 111-01 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35439521 | Derived | 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. |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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|
| hyaluronic acid | Device | compare the therapeutic effects of hyaluronic acid combined dextrose injections with hyaluronic acid injections only to patients with knee osteoarthritis |
|
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 |
| Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |