Additional Effects of Steroid and Dextrose to Hyaluronic Acid on Knee Osteoarthritis
- Conditions
- Knee Osteoarthritis
- Interventions
- Drug: compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritis
- Registration Number
- NCT04165902
- Lead Sponsor
- Taipei Medical University
- Brief Summary
Using double-blind, randomized controlled design to compare the immediate, short-term and intermediate-term additional therapeutic effects of ultrasound-guided corticosteroid injection and dextrose injection of hyaluronic acid injection on patients with knee osteoarthritis, under the basis of International Classification of Functioning, Disability, and Health.
- Detailed Description
A total of 60 patients will be collected. The participants will be randomized into two groups, including hyaluronic acid combined corticosteroid group and hyaluronic acid combined dextrose group. The balance, physical activity (10 meters normal and fast walk, up and downstairs, and 5 repeated chair-rising time, timed up and go test), functional performance and knee-related quality of life (Western Ontario and McMaster Universities Osteoarthritis index、Knee Injury and Osteoarthritis Outcome Score) 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 months after injection. Subjects and evaluators will be both blinded to the group's classification during the whole course of study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- clinical diagnosis of knee osteoarthritis can walk for 15 meters Kellgren-Lawerence grade 2 or greater than 2 can follow up for 6 months
- major diseases will affect balance, such as stroke, infectious diseases, rheumatoid arthritis, dizziness, or vertigo fractures malignance pregnancy or prepare to pregnant received knee injections in the past 6 months previous operation of knee joints
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description steroid plus hyaluronic acid compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritis steroid plus hyaluronic acid injection, one time per week, for 3 weeks dextrose plus hyaluronic acid compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritis dextrose plus hyaluronic acid injection, one time per week, for 3 weeks
- Primary Outcome Measures
Name Time Method Western Ontario and McMaster Universities Osteoarthritis index changes of scores from baseline to at one week, one month, 3 months and 6 months after 3 times of injections; score range: 0-100, higher scores mean a worse outcome assess knee osteoarthritis related performance
- Secondary Outcome Measures
Name Time Method Balance changes of scores from baseling to at one week, one month, 3 months and 6 months after 3 times of injections; score range 0-4, higher scores mean a better outcome Berg Balance scale
physical functional performance-walking change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections 10 meters normal and fast walking speed
physical functional performance-stairs climbing change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections time for up and down stairs
Doppler resistance index changes of scores from baseline to at one week after 1 time of injection and two weeks after 2 times of injection; the lower values indicate a low blood vessel resistance assess knee blood vessel resistance
physical functional performance-chair raising change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections 5 repeated chair-rising time
physical functional performance-balance change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections timed up and go test
Knee Injury and Osteoarthritis Outcome Score changes of scores from baseline to at one week, one month, 3 months and 6 months after 3 times of injections; score range 0-100, higher scores mean at better outcome assess osteoarthritis of knee related function
Trial Locations
- Locations (1)
Shin Kong Wu Ho-Su Memorial Hospital
🇨🇳Taipei, Taiwan