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Effects of Dextrose on Knee Osteoarthritis

Sponsor
Taipei Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03238183
Collaborator
(none)
106
Enrollment
1
Location
2
Arms
23
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
106 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Additional Therapeutic Effects of Dextrose to Hyaluronic Acid on Knee Osteoarthritis: a Double Blind, Randomized-controlled Clinical Trial
Anticipated Study Start Date :
Aug 1, 2017
Anticipated Primary Completion Date :
Jul 1, 2019
Anticipated Study Completion Date :
Jul 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: hyaluronic acid combined dextrose group

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

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

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

    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

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

    Outcome Measures

    Primary Outcome Measures

    1. physical activity-on level walking time [changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection]

      10 meter walking

    2. physical activity-stair climbing time [changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection]

      stairs climbing

    3. physical activity-chair rising time [changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection]

      chair rising

    Secondary Outcome Measures

    1. functional performance [changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection]

      Western Ontario and McMaster Universities Osteoarthritis index

    2. quality of life [changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection]

      Knee Injury and Osteoarthritis Outcome Score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shin Kong Wu Ho-Su Memorial Hospital Taipei Taiwan 111-01

    Sponsors and Collaborators

    • Taipei Medical University

    Investigators

    • Principal Investigator: Ru-Lan Hsieh, Shin Kong Wu Ho-Su Memorial Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ru-Lan Hsieh, Professor, Taipei Medical University
    ClinicalTrials.gov Identifier:
    NCT03238183
    Other Study ID Numbers:
    • MOST 106-2314-B-341-003
    First Posted:
    Aug 3, 2017
    Last Update Posted:
    Aug 3, 2017
    Last Verified:
    Aug 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ru-Lan Hsieh, Professor, Taipei Medical University
    knee osteoarthritis
    hyaluronic acid
    dextrose
    therapeutic effects
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee
    Hyaluronic Acid

    Study Results

    No Results Posted as of Aug 3, 2017