Effects of Knee Injections on Patients With Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Therapeutic Effects of Knee Intra-articular Injections on Patients With Knee Osteoarthritis: a Double-blind, Randomized, Placebo-controlled Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05220527
• Other study ID #: MOST109-2314-B-341-001
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: August 1, 2020
• Est. completion date: July 31, 2022

Study information

• Verified date: January 2022
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Effect of Drug
• Injection
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Triamcinolone plus hyruan
triamcinolone plus hyruan injections, one time per week, for 3 weeks
• vitagen plus hyruan
vitagen plus hyruan injections, one time per week, for 3 weeks
• normal saline plus hyruan
normal saline plus hyruan injections, one time per week, for 3 weeks

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University	Shin Kong Wu Ho-Su Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario and McMaster Universities Osteoarthritis index	assess knee related performance, scores: 0-100, higher score indicates a worse outcome	changes of scores from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
Secondary	physical functional performance-walking	10 meters normal and fast walking speed	changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
Secondary	physical functional performance-stairs climbing	time for up and down stairs	changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
Secondary	physical functional performance-chair rising	time for 5 repeated chair-rising time	changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
Secondary	physical functional performance-balance	time for up and go test	changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
Secondary	Knee Injury and Osteoarthritis Outcome Score	assess knee osteoarthritis related function, scores: 0-100, higher score indicates a better outcome	changes of scores from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections