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Effects of Dextrose on Knee Osteoarthritis

T

Taipei Medical University

Status and phase

Unknown
Phase 4

Conditions

Functional Disturbance
Physical Activity

Treatments

Device: hyaluronic acid
Drug: dextrose

Study type

Interventional

Funder types

Other

Identifiers

NCT03238183
MOST 106-2314-B-341-003

Details and patient eligibility

About

Using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ultrasound guided hyaluronic acid injection and hyaluronic acid combined dextrose injection to patients with knee osteoarthritis.

Full description

A total of 106 patients will be collected. The participants will be randomized into two groups, including hyaluronic acid group and hyaluronic acid combined dextrose group.

The hyaluronic acid group will receive 3 times of hyaluronic acid injection per week in three weeks; the hyaluronic acid combined dextrose group will receive 3 times of hyaluronic acid combined dextrose injection per week in three weeks.

The pain, physical activity, and functional performance 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 month after injection.

Subjects and the evaluator will be both blinded to the group's classification during the whole course of study.

Enrollment

106 estimated patients

Sex

All

Ages

40 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • knee osteoarthritis with Kellgren/Lawrence grade II or III

Exclusion criteria

  • who have neurological deficit, such as stroke who have implant in knee

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

106 participants in 2 patient groups, including a placebo group

hyaluronic acid combined dextrose group
Active Comparator group
Description:
Hyaluronic acid (2 cc) combined 25% dextrose (3.5 cc 50% dextrose plus 3.5 cc 2% lidocaine) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined hyaluronic acid and dextrose injections to hyaluronic acid injections
Treatment:
Drug: dextrose
Device: hyaluronic acid
hyaluronic acid group
Placebo Comparator group
Description:
Hyaluronic acid (2 cc) combined normal saline (3.5 cc normal saline plus 3.5 cc 2% lidocaine) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined hyaluronic acid and dextrose injections to hyaluronic acid injections
Treatment:
Device: hyaluronic acid

Trial contacts and locations

1

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Central trial contact

Ru-Lan Hsieh; Ru-Lan Hsieh

Data sourced from clinicaltrials.gov

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