Effects of Knee Injections on Patients With Knee Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2022-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Knee Osteoarthritis Injection Effect of Drug

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Study group

triamcinolone plus hyruan injection

Group Type EXPERIMENTAL

Triamcinolone plus hyruan

Intervention Type DRUG

triamcinolone plus hyruan injections, one time per week, for 3 weeks

Experimental

vitagen plus hyruan injection

Group Type ACTIVE_COMPARATOR

vitagen plus hyruan

Intervention Type DRUG

vitagen plus hyruan injections, one time per week, for 3 weeks

Placebo

normal saline plus hyruan injection

Group Type PLACEBO_COMPARATOR

normal saline plus hyruan

Intervention Type DRUG

normal saline plus hyruan injections, one time per week, for 3 weeks

Interventions

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Triamcinolone plus hyruan

triamcinolone plus hyruan injections, one time per week, for 3 weeks

Intervention Type DRUG

vitagen plus hyruan

vitagen plus hyruan injections, one time per week, for 3 weeks

Intervention Type DRUG

normal saline plus hyruan

normal saline plus hyruan injections, one time per week, for 3 weeks

Intervention Type DRUG

Other Intervention Names

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corticosteroids plus hyaluronic acid dextrose plus hyaluronic acid normal saline plus hyaluronic acid

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No