Effects of Knee Injections on Patients With Knee Osteoarthritis

Taipei Medical University

Status and phase: Unknown; Phase 4

Conditions: Injection; Knee Osteoarthritis; Effect of Drug

Treatments: Drug: Triamcinolone plus hyruan; Drug: normal saline plus hyruan; Drug: vitagen plus hyruan

Study type: Interventional

Funder types: Other

Identifiers

NCT05220527

MOST109-2314-B-341-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

Study group

Experimental group

Description:

triamcinolone plus hyruan injection

Treatment:

Drug: Triamcinolone plus hyruan

Experimental

Active Comparator group

Description:

vitagen plus hyruan injection

Treatment:

Drug: vitagen plus hyruan

Placebo

Placebo Comparator group

Description:

normal saline plus hyruan injection

Treatment:

Drug: normal saline plus hyruan