Additional Effects of Triamcinolone to Hyaluronic Acid on Knee Osteoarthritis

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02949466
• Other study ID #: MOST 105-2314-B-341-002
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 25, 2016
• Last updated: October 29, 2016
• Start date: October 2016
• Est. completion date: July 2017

Study information

• Verified date: October 2016
• Source: Taipei Medical University
• Contact: Ru-Lan Hsieh, MD
• Phone: 886-2-28332211
• Email: M001052[@]ms.skh.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: National Science Council
• Study type: Interventional

Clinical Trial Summary

Using a double-blind, randomized controlled design to investigate the additional therapeutic effects of 3 times of combined triamcinolone and hyaluronic acid injections to 3 times of hyaluronic acid injections to patients with knee osteoarthritis.

Description:

A total of 56 patients will be enrolled and randomized into two groups, including 3 times of triamcinolone combined hyaluronic acid injections group and 3 times of hyaluronic acid injections group.

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

Physical activities and functional performance will be evaluated at before injection, at after one week, one month, three months, and six months of completion of 3 times of injections.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Functional Performance
• Osteoarthritis
• Osteoarthritis, Knee
• Physical Activity

Intervention

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

Device:
• Hyaluronic acid
compare the additional therapeutic effects of triamcinolone combined with hyaluronic acid injections to 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	Functional performance assessed with the Western Ontario and McMaster Universities Osteoarthritis Index	Western Ontario and McMaster Universities Osteoarthritis Index	changes from baseline to at after one week, one month, three months, and six months of completion of injections	No
Secondary	10 meter walk test	10 meter walk as fast as possible	changes from baseline to at after one week, one month, three months, and six months of completion of injections	No
Secondary	Quality of life assessed with the Knee Injury and Osteoarthritis Outcome Score	Knee Injury and Osteoarthritis Outcome Score	changes from baseline to at after one week, one month, three months, and six months of completion of injections	No
Secondary	5 times rapid chair rising test	rapid chair rising for 5 times as fast as possible	changes from baseline to at after one week, one month, three months, and six months of completion of injections	No