Clinical trial NCT05220527: Effects of Knee Injections on Patients With Knee Osteoarthritis
Official title: Therapeutic Effects of Knee Intra-articular Injections on Patients With Knee Osteoarthritis: a Double-blind, Randomized, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Knee Osteoarthritis
Injection
Effect of Drug
Keywords: knee osteoarthritis
steroid
hyaluronic acid
dextrose
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: Shin Kong Wu Ho-Su Memorial Hospital
First posted: 2022-02-02
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Using a double-blind, randomized, placebo-controlled design to compare the immediate, short-term, and intermediate-term additional therapeutic effects of ultrasound-guided corticosteroid injection and dextrose injection to 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 three groups, including the hyaluronic acid combined corticosteroid group, hyaluronic acid combined dextrose group, and hyaluronic acid combined normal saline group (placebo group). The functional performance and knee-related quality of life (Western Ontario and McMaster Universities Osteoarthritis index、Knee Injury and Osteoarthritis Outcome Score), pain (pressure threshold by pain pressure ergometer), and physical activity (10 meters normal and fast walk, up and downstairs, 5 repeated chair-rising time, timed up and go test) and image progression by high-resolution ultrasound will be evaluated before treatment, one week after injections, one month after injections, three months after injections, and six months after injections.

Participants and evaluators will be both blinded to the group's allocation during the whole course of intervention.

Eligibility criteria: Inclusion Criteria:

1. clinical diagnosis of knee osteoarthritis
2. can walk for 15 meters
3. Kellgren-Lawrence grade 2 or greater
4. can follow up for 6 months

Exclusion Criteria:

1. Major diseases will affect balance, such as stroke
2. infectious disease,
3. rheumatoid arthritis,
4. malignancy
5. pregnancy or prepare to pregnant
6. received knee injections in the past 6 months
7. previous knee operation history

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis index
timeFrame: changes of scores from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
Secondary outcomes:
measure: physical functional performance-walking
timeFrame: changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
measure: physical functional performance-stairs climbing
timeFrame: changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
measure: physical functional performance-chair rising
timeFrame: changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
measure: physical functional performance-balance
timeFrame: changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: changes of scores from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Ru-Lan Hsieh, MD
role: STUDY_CHAIR
References: