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Completed

NCT Number: NCT05139875

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

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Thammasat University Hospital

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Betamethasone Dipropionate / Betamethasone Sodium Phosphate

Drug

Single intra-articular Betamethasone Dipropionate / Betamethasone Sodium Phosphate (Diprospan) injections to affected knee

Other names: Diprospan

Triamcinolone Acetonide 40mg/mL

Drug

Single intra-articular Triamcinolone Acetonide injections to affected knee

Other names: Kanolone-F

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.
  2. 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.
  3. 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
  4. 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.
  5. 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.
  6. 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.

  7. 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)

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 1, 2021
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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