Clinical trial NCT03238183: Effects of Dextrose on Knee Osteoarthritis
Official title: Additional Therapeutic Effects of Dextrose to Hyaluronic Acid on Knee Osteoarthritis: a Double Blind, Randomized-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Physical Activity
Functional Disturbance
Keywords: knee osteoarthritis
hyaluronic acid
dextrose
therapeutic effects
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 106
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: physical activity-on level walking time
timeFrame: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection
measure: physical activity-stair climbing time
timeFrame: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection
measure: physical activity-chair rising time
timeFrame: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection
Secondary outcomes:
measure: functional performance
timeFrame: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection
measure: quality of life
timeFrame: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection
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
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsieh RL, Lee WC. Effects of Intra-articular Coinjections of Hyaluronic Acid and Hypertonic Dextrose on Knee Osteoarthritis: A Prospective, Randomized, Double-Blind Trial. Arch Phys Med Rehabil. 2022 Aug;103(8):1505-1514. doi: 10.1016/j.apmr.2022.04.001. Epub 2022 Apr 16.