Knee OsteoarthritisPhase 4NCT05139875
Comparing Intra-articular Betamethasone (Diprospan) and Triamcinolone Acetonide Injection in Knee Osteoarthritis
A Phase 4 study testing Betamethasone Dipropionate / Betamethasone Sodium Phosphate and Triamcinolone Acetonide 40mg/mL in people with Knee Osteoarthritis, run by Thammasat University at 1 site in Thailand.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Betamethasone Dipropionate / Betamethasone Sodium Phosphate and Triamcinolone Acetonide 40mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2022to 30 Apr 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Symptomatic Primary knee osteoarthritis (Kellgren-Lawrence stage 2 or 3)
- Failed other conservative treatment
- Comply with protocol
Who cannot join
- 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
Show all 10Show fewer
- Primary or secondary adrenal insufficiency
- Coagulopathy or current anticoagulant used
- Current steroid used
- Lower extremity weakness
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Thammasat University Hospital
Khlong Luang, Changwat Pathum Thani, 12120
About this study
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
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
Read the 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
- Conditions
- Knee Osteoarthritis
- Being tested
- Betamethasone Dipropionate / Betamethasone Sodium Phosphate, Triamcinolone Acetonide 40mg/mL
- Keywords
- Intra-articular injections, Corticosteroids, Triamcinolone acetonide, Betamethasone, Nonoperative management
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betamethasone Dipropionate / Betamethasone Sodium PhosphateDrug
Also called Diprospan
Single intra-articular Betamethasone Dipropionate / Betamethasone Sodium Phosphate (Diprospan) injections to affected knee
Triamcinolone Acetonide 40mg/mLDrug
Also called Kanolone-F
Single intra-articular Triamcinolone Acetonide injections to affected knee
| Study group | Role | What they receive |
|---|---|---|
| Betamethasone (Diprospan) | Experimental | Participant received single intra-articular Betamethasone Dipropionate / Betamethasone Sodium Phosphate 1 ml Receives: Drug: Betamethasone Dipropionate / Betamethasone Sodium Phosphate |
| Triamcinolone acetonide | Active comparator | Participant received single intra-articular Triamcinolone acetonide 40 mg Receives: Drug: Triamcinolone Acetonide 40mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (7)
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.
Measured: 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
- 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.
Measured: 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
- Flexion and extension angle of the knee is measured by a long-arm goniometer
Measured: 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
- 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.
Measured: 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
- 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.
Measured: Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
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.
Measured: 1 month, 3 months, 6 months 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)
Measured: 6 months after intra-articular injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start1 Jan 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized and assigned to betamethasone (Diprospan) group or Triamcinolone acetonide group in parallel for the duration of the study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kittipong Wattanasirisombat, Thammasat University
- Investigators
- KITTIPONG WATTANASIRISOMBAT, MD, Study director, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139875
- Sponsor's protocol ID
- MTU-EC-OT-1-266/64
- Status last verified
- Aug 2024
- First submitted
- 18 Nov 2021
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Katz JN, Arant KR, Loeser RF. Diagnosis and Treatment of Hip and Knee Osteoarthritis: A Review. JAMA. 2021 Feb 9;325(6):568-578. doi: 10.1001/jama.2020.22171.
PubMed 33560326Uson J, Rodriguez-Garcia SC, Castellanos-Moreira R, O'Neill TW, Doherty M, Boesen M, Pandit H, Moller Parera I, Vardanyan V, Terslev L, Kampen WU, D'Agostino MA, Berenbaum F, Nikiphorou E, Pitsillidou IA, de la Torre-Aboki J, Carmona L, Naredo E. EULAR recommendations for intra-articular therapies. Ann Rheum Dis. 2021 Oct;80(10):1299-1305. doi: 10.1136/annrheumdis-2021-220266. Epub 2021 May 25.
PubMed 34035002Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, Blanco FJ, Espinosa R, Haugen IK, Lin J, Mandl LA, Moilanen E, Nakamura N, Snyder-Mackler L, Trojian T, Underwood M, McAlindon TE. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.
PubMed 31278997Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Rheumatol. 2020 Feb;72(2):220-233. doi: 10.1002/art.41142. Epub 2020 Jan 6.
PubMed 31908163Jevsevar DS, Brown GA, Jones DL, Matzkin EG, Manner PA, Mooar P, Schousboe JT, Stovitz S, Sanders JO, Bozic KJ, Goldberg MJ, Martin WR 3rd, Cummins DS, Donnelly P, Woznica A, Gross L; American Academy of Orthopaedic Surgeons. The American Academy of Orthopaedic Surgeons evidence-based guideline on: treatment of osteoarthritis of the knee, 2nd edition. J Bone Joint Surg Am. 2013 Oct 16;95(20):1885-6. doi: 10.2106/00004623-201310160-00010. No abstract available.
PubMed 24288804Oo WM, Liu X, Hunter DJ. Pharmacodynamics, efficacy, safety and administration of intra-articular therapies for knee osteoarthritis. Expert Opin Drug Metab Toxicol. 2019 Dec;15(12):1021-1032. doi: 10.1080/17425255.2019.1691997. Epub 2019 Nov 13.
PubMed 31709838Garg N, Perry L, Deodhar A. Intra-articular and soft tissue injections, a systematic review of relative efficacy of various corticosteroids. Clin Rheumatol. 2014 Dec;33(12):1695-706. doi: 10.1007/s10067-014-2572-8. Epub 2014 Mar 21.
PubMed 24651914Douglas RJ. Corticosteroid injection into the osteoarthritic knee: drug selection, dose, and injection frequency. Int J Clin Pract. 2012 Jul;66(7):699-704. doi: 10.1111/j.1742-1241.2012.02963.x.
PubMed 22698422Cole BJ, Schumacher HR Jr. Injectable corticosteroids in modern practice. J Am Acad Orthop Surg. 2005 Jan-Feb;13(1):37-46. doi: 10.5435/00124635-200501000-00006.
PubMed 15712981Schumacher HR, Chen LX. Injectable corticosteroids in treatment of arthritis of the knee. Am J Med. 2005 Nov;118(11):1208-14. doi: 10.1016/j.amjmed.2005.05.003.
PubMed 16271901Husby G, Kass E, Spongsveen KL. Comparative double-blind trial of intra-articular injections of two long-acting forms of betamethasone. Scand J Rheumatol. 1975;4(3):118-20. doi: 10.3109/03009747509165439.
PubMed 1101375Liu D, Ahmet A, Ward L, Krishnamoorthy P, Mandelcorn ED, Leigh R, Brown JP, Cohen A, Kim H. A practical guide to the monitoring and management of the complications of systemic corticosteroid therapy. Allergy Asthma Clin Immunol. 2013 Aug 15;9(1):30. doi: 10.1186/1710-1492-9-30.
PubMed 23947590Yavuz U, Sokucu S, Albayrak A, Ozturk K. Efficacy comparisons of the intraarticular steroidal agents in the patients with knee osteoarthritis. Rheumatol Int. 2012 Nov;32(11):3391-6. doi: 10.1007/s00296-011-2188-0. Epub 2011 Nov 5.
PubMed 22057944Wollstein R, Chaimsky G, Carlson L, Watson HK, Wollstein G, Saleh J. Evaluating short-term pain after steroid injection. Am J Orthop (Belle Mead NJ). 2007 Mar;36(3):128-31.
PubMed 17461394Kelly AM. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J. 2001 May;18(3):205-7. doi: 10.1136/emj.18.3.205.
PubMed 11354213
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05139875
- Acronym / sponsor ID
- MTU-EC-OT-1-266/64
- Conditions
- Knee Osteoarthritis
- Keywords
- Intra-articular injections, Corticosteroids, Triamcinolone acetonide, Betamethasone, Nonoperative management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized and assigned to betamethasone (Diprospan) group or Triamcinolone acetonide group in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Betamethasone (Diprospan) | Experimental | Drug: Betamethasone Dipropionate / Betamethasone Sodium PhosphateParticipant received single intra-articular Betamethasone Dipropionate / Betamethasone Sodium Phosphate 1 ml |
| Triamcinolone acetonide | Active comparator | Drug: Triamcinolone Acetonide 40mg/mLParticipant received single intra-articular Triamcinolone acetonide 40 mg |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic Primary knee osteoarthritis (Kellgren-Lawrence stage 2 or 3)
- Failed other conservative treatment
- Comply with protocol
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Betamethasone Dipropionate / Betamethasone Sodium PhosphateAlso: DiprospanSingle intra-articular Betamethasone Dipropionate / Betamethasone Sodium Phosphate (Diprospan) injections to affected knee | Drug | Betamethasone (Diprospan) |
| Triamcinolone Acetonide 40mg/mLAlso: Kanolone-FSingle intra-articular Triamcinolone Acetonide injections to affected knee | Drug | Triamcinolone acetonide |
Primary outcome
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
7 secondary outcomes
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
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
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
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
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
Incidence of side effects of intra-articular steroid injection
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Background: PubMed 33560326Katz JN, Arant KR, Loeser RF. Diagnosis and Treatment of Hip and Knee Osteoarthritis: A Review. JAMA. 2021 Feb 9;325(6):568-578. doi: 10.1001/jama.2020.22171.
- Background: PubMed 34035002Uson J, Rodriguez-Garcia SC, Castellanos-Moreira R, O'Neill TW, Doherty M, Boesen M, Pandit H, Moller Parera I, Vardanyan V, Terslev L, Kampen WU, D'Agostino MA, Berenbaum F, Nikiphorou E, Pitsillidou IA, de la Torre-Aboki J, Carmona L, Naredo E. EULAR recommendations for intra-articular therapies. Ann Rheum Dis. 2021 Oct;80(10):1299-1305. doi: 10.1136/annrheumdis-2021-220266. Epub 2021 May 25.
- Background: PubMed 31278997Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, Blanco FJ, Espinosa R, Haugen IK, Lin J, Mandl LA, Moilanen E, Nakamura N, Snyder-Mackler L, Trojian T, Underwood M, McAlindon TE. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.
- Background: PubMed 31908163Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Rheumatol. 2020 Feb;72(2):220-233. doi: 10.1002/art.41142. Epub 2020 Jan 6.
- Background: PubMed 24288804Jevsevar DS, Brown GA, Jones DL, Matzkin EG, Manner PA, Mooar P, Schousboe JT, Stovitz S, Sanders JO, Bozic KJ, Goldberg MJ, Martin WR 3rd, Cummins DS, Donnelly P, Woznica A, Gross L; American Academy of Orthopaedic Surgeons. The American Academy of Orthopaedic Surgeons evidence-based guideline on: treatment of osteoarthritis of the knee, 2nd edition. J Bone Joint Surg Am. 2013 Oct 16;95(20):1885-6. doi: 10.2106/00004623-201310160-00010. No abstract available.
- Background: PubMed 31709838Oo WM, Liu X, Hunter DJ. Pharmacodynamics, efficacy, safety and administration of intra-articular therapies for knee osteoarthritis. Expert Opin Drug Metab Toxicol. 2019 Dec;15(12):1021-1032. doi: 10.1080/17425255.2019.1691997. Epub 2019 Nov 13.
- Background: PubMed 24651914Garg N, Perry L, Deodhar A. Intra-articular and soft tissue injections, a systematic review of relative efficacy of various corticosteroids. Clin Rheumatol. 2014 Dec;33(12):1695-706. doi: 10.1007/s10067-014-2572-8. Epub 2014 Mar 21.
- Results publication: PubMed 22698422Douglas RJ. Corticosteroid injection into the osteoarthritic knee: drug selection, dose, and injection frequency. Int J Clin Pract. 2012 Jul;66(7):699-704. doi: 10.1111/j.1742-1241.2012.02963.x.
- Results publication: PubMed 15712981Cole BJ, Schumacher HR Jr. Injectable corticosteroids in modern practice. J Am Acad Orthop Surg. 2005 Jan-Feb;13(1):37-46. doi: 10.5435/00124635-200501000-00006.
- Results publication: PubMed 16271901Schumacher HR, Chen LX. Injectable corticosteroids in treatment of arthritis of the knee. Am J Med. 2005 Nov;118(11):1208-14. doi: 10.1016/j.amjmed.2005.05.003.
- Results publication: PubMed 1101375Husby G, Kass E, Spongsveen KL. Comparative double-blind trial of intra-articular injections of two long-acting forms of betamethasone. Scand J Rheumatol. 1975;4(3):118-20. doi: 10.3109/03009747509165439.
- Results publication: PubMed 23947590Liu D, Ahmet A, Ward L, Krishnamoorthy P, Mandelcorn ED, Leigh R, Brown JP, Cohen A, Kim H. A practical guide to the monitoring and management of the complications of systemic corticosteroid therapy. Allergy Asthma Clin Immunol. 2013 Aug 15;9(1):30. doi: 10.1186/1710-1492-9-30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KITTIPONG WATTANASIRISOMBAT, MD study director
Thammasat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Betamethasone Dipropionate / Betamethasone Sodium Phosphate and Triamcinolone Acetonide 40mg/mL in people with Knee Osteoarthritis, run by Thammasat University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05139875, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.