Comparing Intra-articular Betamethasone (Diprospan) and Triamcinolone Acetonide Injection in Knee Osteoarthritis

January 1, 2024 updated by: Kittipong Wattanasirisombat, Thammasat University

A Comparative Study of Betamethasone (Diprospan) and Triamcinolone Acetonide as Single Intra-Articular Injection in Knee Osteoarthritis, A Double-Blinded, Randomized Controlled Trial

The purpose of this study is to compare the efficacy of Intra-articular corticosteroid injection between Betamethasone (Diprospan) and Triamcinolone acetonide for treatment of knee osteoarthritis

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent will be chosen for eligibility for the study entry. At day 0 (before intra-articular injection), patients who meet the eligibility criteria will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Betamethasone (Diprospan 1 ml) or Triamcinolone acetonide (40 mg) single intra-articular injection

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
    • Pathumthani
      • Khlong Luang, Pathumthani, Thailand, 12120
        • Thammasat University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Symptomatic Primary knee osteoarthritis (Kellgren-Lawrence stage 2 or 3)
  2. Failed other conservative treatment
  3. Comply with protocol

Exclusion Criteria:

  1. Allergy to any of the medications in this protocol (Betamethasone, Triamcinolone, Paracetamol, Tramadol)
  2. Previous fracture or surgical procedure
  3. Previous intra-articular injection in the past 6 months
  4. Previous oral Symptomatic slow-acting drugs for osteoarthritis (SYSADOA) (Glucosamine, Diacerein) used in the past 6 months
  5. Current infection in the affected limb
  6. Uncontrolled Diabetes Mellitus
  7. Primary or secondary adrenal insufficiency
  8. Coagulopathy or current anticoagulant used
  9. Current steroid used
  10. Lower extremity weakness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Betamethasone (Diprospan)
Participant received single intra-articular Betamethasone Dipropionate / Betamethasone Sodium Phosphate 1 ml
Drug: Betamethasone Dipropionate / Betamethasone Sodium Phosphate
Single intra-articular Betamethasone Dipropionate / Betamethasone Sodium Phosphate (Diprospan) injections to affected knee
Other Names:
  • Diprospan
Active Comparator: Triamcinolone acetonide
Participant received single intra-articular Triamcinolone acetonide 40 mg
Drug: Triamcinolone Acetonide 40mg/mL
Single intra-articular Triamcinolone Acetonide injections to affected knee
Other Names:
  • Kanolone-F

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of 100-mm Visual analog scale (VAS) Pain Score between Betamethasone (Diprospan) and Triamcinolone group
Time Frame: Baseline before intra-articular injection, 1 day, 2 days, 3 days, 1 week, 3 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months after the day of intra-articular injection
  • The 100-mm VAS pain score is a self-reported instrument assessing Pain Score at 1 day, 2 days, 3 days, 1 week, 3 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months after the day of intra-articular injection
  • Participants will assess the VAS pain score at rest and on-movement
  • VAS Pain at rest is evaluated when the participant's wakeup in the morning
  • VAS Pain on-movement is evaluated when the participant's walking for 10 meters and then resting for 5 minutes
  • Possible scores range from 0 (no pain) to 100 (worst imaginable pain)
  • Higher scores mean a worse pain
Baseline before intra-articular injection, 1 day, 2 days, 3 days, 1 week, 3 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months after the day of intra-articular injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of Modified Western Ontario and McMaster Universities Arthritis Index (WOMAC) score between Betamethasone (Diprospan) and Triamcinolone group
Time Frame: Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
  • The Modified WOMAC score is a validated, self-reported instrument consisting of 24 items divided into 3 subscales (Pain, Stiffness, Physical function).
  • The test questions are scored on a scale of 0-4, which corresponds to None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
  • Possible scores range from 0-20 for pain, 0-8 for Stiffness, 0-68 for Physical function.
  • a sum of the scores for all three subscales gives a total WOMAC score (0-96)
  • Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
Difference of University of California and Los Angeles (UCLA) score between Betamethasone (Diprospan) and Triamcinolone group
Time Frame: Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
  • The UCLA is a 10-point scale measurement that evaluates patients' daily activity levels.
  • The 10-point scale is leveled from 1 to 10 (1= worst, 10 = best).
  • Level 1 is wholly inactive and dependent on others, while level 6 is unlimited housework and shopping and level 10 is regular participation in impact sports, such as jogging or tennis.
Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
Difference of Range of motion between Betamethasone (Diprospan) and Triamcinolone group
Time Frame: Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
- Flexion and extension angle of the knee is measured by a long-arm goniometer
Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
Difference of Time up-and-go test between Betamethasone (Diprospan) and Triamcinolone group
Time Frame: Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
  • The Time up-and-go test (TUGT) measures the time (seconds) that the patient takes to rise from a chair and walk for 3 meters. Then, he or she turns around and comes back to the seat at the initial position.
  • They were permitted to use walking aids if they wished.
  • TUGT was a reliable and valid test for quantifying functional mobility.
Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
Difference of 2-minutes walking test between Betamethasone (Diprospan) and Triamcinolone group
Time Frame: Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
  • Participants were instructed to walk for 2 minutes at their normal pace up and down a designated corridor, turning around at each end of the corridor without stopping
  • They were permitted to use walking aids if they wished.
  • The results were recorded as the total distance walked in meters.
Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
Incidence of side effects of intra-articular steroid injection
Time Frame: 1 month, 3 months, 6 months after intra-articular injection
Injection site reaction, Erythema, Swelling, Injection-site pain, Pruritus, cellulitis were observed after intra-articular injection.
1 month, 3 months, 6 months after intra-articular injection
Difference of Total Paracetamol and Tramadol used between Betamethasone (Diprospan) and Triamcinolone group
Time Frame: 6 months after intra-articular injection
  • Post-injection protocol, Participants can use Paracetamol 500 mg 2 tabs every 4 hours for knee pain if it did not relieve the pain they can take Tramadol 50 mg 1 cap every 6 hours.
  • The total use of Paracetamol and Tramadol was recorded. (tablet)
6 months after intra-articular injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Investigators

  • Study Director: KITTIPONG WATTANASIRISOMBAT, MD, Thammasat University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

November 18, 2021

First Submitted That Met QC Criteria

November 18, 2021

First Posted (Actual)

December 1, 2021

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

January 1, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTU-EC-OT-1-266/64

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following article publication.

IPD Sharing Access Criteria

  • Researchers who provide a methodologically sound proposal.
  • To achieve aims in the approved proposal.
  • Proposals should be directed to kittipong43705@gmail.com.
  • To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Osteoarthritis

Clinical Trials on Betamethasone Dipropionate / Betamethasone Sodium Phosphate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe