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

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Betamethasone Dipropionate / Betamethasone Sodium Phosphate
Triamcinolone Acetonide 40mg/mL
Sponsored by
Thammasat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Intra-articular injections, Corticosteroids, Triamcinolone acetonide, Betamethasone, Nonoperative management

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thammasat University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Betamethasone (Diprospan)

Triamcinolone acetonide

Arm Description

Participant received single intra-articular Betamethasone Dipropionate / Betamethasone Sodium Phosphate 1 ml

Participant received single intra-articular Triamcinolone acetonide 40 mg

Outcomes

Primary Outcome Measures

Difference of 100-mm Visual analog scale (VAS) Pain Score between Betamethasone (Diprospan) and Triamcinolone group
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 Outcome Measures

Difference of Modified Western Ontario and McMaster Universities Arthritis Index (WOMAC) score between Betamethasone (Diprospan) and Triamcinolone group
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.
Difference of University of California and Los Angeles (UCLA) score between Betamethasone (Diprospan) and Triamcinolone group
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.
Difference of Range of motion between Betamethasone (Diprospan) and Triamcinolone group
- Flexion and extension angle of the knee is measured by a long-arm goniometer
Difference of Time up-and-go test between Betamethasone (Diprospan) and Triamcinolone group
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.
Difference of 2-minutes walking test between Betamethasone (Diprospan) and Triamcinolone group
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.
Incidence of side effects of intra-articular steroid injection
Injection site reaction, Erythema, Swelling, Injection-site pain, Pruritus, cellulitis were observed after intra-articular injection.
Difference of Total Paracetamol and Tramadol used between Betamethasone (Diprospan) and Triamcinolone group
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)

Full Information

First Posted
November 18, 2021
Last Updated
January 18, 2022
Sponsor
Thammasat University
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1. Study Identification

Unique Protocol Identification Number
NCT05139875
Brief Title
Comparing Intra-articular Betamethasone (Diprospan) and Triamcinolone Acetonide Injection in Knee Osteoarthritis
Official Title
A Comparative Study of Betamethasone (Diprospan) and Triamcinolone Acetonide as Single Intra-Articular Injection in Knee Osteoarthritis, A Double-Blinded, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Intra-articular injections, Corticosteroids, Triamcinolone acetonide, Betamethasone, Nonoperative management

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized and assigned to betamethasone (Diprospan) group or Triamcinolone acetonide group in parallel for the duration of the study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Participant and Care Provider will not know which drug is injected to the investigated knee because the opaque syringe is used to inject. Investigator and outcomes assessor will not known the group of participants because randomization, they only know the number of the participants.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Betamethasone (Diprospan)
Arm Type
Experimental
Arm Description
Participant received single intra-articular Betamethasone Dipropionate / Betamethasone Sodium Phosphate 1 ml
Arm Title
Triamcinolone acetonide
Arm Type
Active Comparator
Arm Description
Participant received single intra-articular Triamcinolone acetonide 40 mg
Intervention Type
Drug
Intervention Name(s)
Betamethasone Dipropionate / Betamethasone Sodium Phosphate
Other Intervention Name(s)
Diprospan
Intervention Description
Single intra-articular Betamethasone Dipropionate / Betamethasone Sodium Phosphate (Diprospan) injections to affected knee
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide 40mg/mL
Other Intervention Name(s)
Kanolone-F
Intervention Description
Single intra-articular Triamcinolone Acetonide injections to affected knee
Primary Outcome Measure Information:
Title
Difference of 100-mm Visual analog scale (VAS) Pain Score between Betamethasone (Diprospan) and Triamcinolone group
Description
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
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
Secondary Outcome Measure Information:
Title
Difference of Modified Western Ontario and McMaster Universities Arthritis Index (WOMAC) score between Betamethasone (Diprospan) and Triamcinolone group
Description
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.
Time Frame
Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
Title
Difference of University of California and Los Angeles (UCLA) score between Betamethasone (Diprospan) and Triamcinolone group
Description
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.
Time Frame
Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
Title
Difference of Range of motion between Betamethasone (Diprospan) and Triamcinolone group
Description
- Flexion and extension angle of the knee is measured by a long-arm goniometer
Time Frame
Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
Title
Difference of Time up-and-go test between Betamethasone (Diprospan) and Triamcinolone group
Description
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.
Time Frame
Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
Title
Difference of 2-minutes walking test between Betamethasone (Diprospan) and Triamcinolone group
Description
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.
Time Frame
Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
Title
Incidence of side effects of intra-articular steroid injection
Description
Injection site reaction, Erythema, Swelling, Injection-site pain, Pruritus, cellulitis were observed after intra-articular injection.
Time Frame
1 month, 3 months, 6 months after intra-articular injection
Title
Difference of Total Paracetamol and Tramadol used between Betamethasone (Diprospan) and Triamcinolone group
Description
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)
Time Frame
6 months after intra-articular injection

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
KITTIPONG WATTANASIRISOMBAT, MD
Phone
+66899498582
Email
kittipong43705@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KITTIPONG WATTANASIRISOMBAT, MD
Organizational Affiliation
Thammasat University
Official's Role
Study Director
Facility Information:
Facility Name
Thammasat University Hospital
City
Khlong Luang
State/Province
Pathumthani
ZIP/Postal Code
12120
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kittipong Wattanasirisombat, MD
Phone
0899498582
Email
kittipong43705@gmail.com
First Name & Middle Initial & Last Name & Degree
Piya Pinsornsak, Prof.
First Name & Middle Initial & Last Name & Degree
Krit Boontanapibul, Asst. Prof.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
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Comparing Intra-articular Betamethasone (Diprospan) and Triamcinolone Acetonide Injection in Knee Osteoarthritis

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