Effects of Dextrose on Knee Osteoarthritis

Physical Activity Clinical Trial

Official title:

Additional Therapeutic Effects of Dextrose to Hyaluronic Acid on Knee Osteoarthritis: a Double Blind, Randomized-controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03238183
• Other study ID #: MOST 106-2314-B-341-003
• Status: Not yet recruiting
• Phase: Phase 4
• First received: July 28, 2017
• Last updated: August 2, 2017
• Start date: August 2017
• Est. completion date: July 2019

Study information

• Verified date: August 2017
• Source: Taipei Medical University
• Contact: Ru-Lan Hsieh
• Phone: 228332211
• Email: M001052[@]ms.skh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 106
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Functional Disturbance
• Osteoarthritis
• Osteoarthritis, Knee
• Pathologic Processes
• Physical Activity

Intervention

Drug:
• dextrose
compare the therapeutic effects of hyaluronic acid combined dextrose injections with hyaluronic acid injections only to patients with knee osteoarthritis

Device:
• hyaluronic acid
compare the therapeutic effects of hyaluronic acid combined dextrose injections with hyaluronic acid injections only to patients with knee osteoarthritis

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	physical activity-on level walking time	10 meter walking	changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection
Primary	physical activity-stair climbing time	stairs climbing	changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection
Primary	physical activity-chair rising time	chair rising	changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection
Secondary	functional performance	Western Ontario and McMaster Universities Osteoarthritis index	changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection
Secondary	quality of life	Knee Injury and Osteoarthritis Outcome Score	changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection