Intraarticular Glucose Versus Hyaluronic Acid Injection for Knee Osteoarthrosis

NCT03690232 | Unknown

• 1 other identifier: 2018-01-014C
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a prospective, randomized controlled, double-blind study. The enrolled patients were randomly divided into two groups: the intraarticular glucose group and the intraarticular HA group.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales

  12 weeks

Secondary Outcomes (2)

• Lequesne index

  0,6,12 weeks

• visual analogue scale (VAS)

  0,6,12 weeks

Study Arms (2)

Glucose group

EXPERIMENTAL

The glucose group underwent 3 sessions of 6cc 25% glucose injection with a 2-week interval between each treatment

Drug: glucose water

hyaluronic acid group

ACTIVE COMPARATOR

The HA group was administered intra-articular HA ((Hyruan Plus® , average MW 3000 kD; LG Life Sciences Ltd, Korea)) for sessions with a 1-week interval between each treatment.

Drug: hyaluronic aicd

Interventions

glucose water DRUG

3 sessions of 6cc 25% glucose injection with a 2-week interval

Glucose group

hyaluronic aicd DRUG

intra-articular HA ((Hyruan Plus® , average MW 3000 kD; LG Life Sciences Ltd, Korea)) for sessions with a 1-week interval between each treatment

Also known as: Hyruan

hyaluronic acid group

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• people aged 45 years or more;
• subjects diagnosed with knee OA according to the clinical criteria of the American College of Rheumatology
• subjects diagnosed with grade II or III OA during radiological examination as defined by the radiological classification of Kellgren and Lawrence (K-L) scale for knee OA
• subjects with tenderness in the medial tibial plateau area

You may not qualify if:

• subjects having other illnesses of neurologic diseases, cardiac disorders, hemodynamically unstable systems, or physical functions;
• Inflammatory arthritis or subjects with acute knee arthritis
• subjects who have received intraarticular injection on the affected knee within the past 3 months.
• subjects with previous medical histories involving the affected knee such as surgeries, cancer and maligament tumors.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 241, Taiwan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jia chi Wang, MD

  Taipei Veterans General Hospital, Taiwan

  STUDY DIRECTOR

Central Study Contacts

Jia chi Wang, MD

CONTACT

886-2-28757361; jcwang0726@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: outcomes assessor and participant do not know the treatment patient received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The study in the first year is a prospective, randomized controlled, double-blind study. The enrolled patients were randomly divided into two groups: the intraarticular glucose group and the intraarticular HA group.

Study Record Dates

• First Submitted: September 9, 2018
• First Posted: October 1, 2018
• Study Start: October 8, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)