OsteoarthritisPhase 4NCT04278833
Comparative Effectiveness of Particulate Versus Nonparticulate Steroid Injections for Musculoskeletal Conditions
A Phase 4 study testing Triamcinolone or Betamethasone and Dexamethasone in people with Osteoarthritis and Tendinopathy, run by Stanford University at 1 site in United States.
Trial summary
This aims of this study are: 1. To determine if particulate or non-particulate corticosteroid injections are more effective at treating pain from musculoskeletal pathologies of the hip, glenohumeral joint, biceps tendon, or subacromial/subdeltoid bursa at 2 weeks, 3 months, or 6 months. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Tendinopathy, Impingement Shoulder
- What is being tested?
- Triamcinolone or Betamethasone and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 28 May 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18
- Ability to provide informed consent
- Capable of complying with the outcome instruments used
- Capable of attending all planned follow up visits
- Patient is deemed appropriate for intra-articular hip, glenohumeral, peri-tendinous biceps, or subdeltoid bursa corticosteroid injection by their treating physician for the treatment of painful musculoskeletal condition
- Average pain of greater than or equal to 4/10 over the last 7 days
Who cannot join
- Unclear diagnosis
- Pregnancy
- Incarcerated patients
- Prior corticosteroid injection into the same anatomical site within the last 3 months
- Prior prosthetic surgery on the joint
- Any condition that increases injection risk such as bleeding tendencies, uncontrolled diabetes, current active infection, or infection requiring antibiotics within the last 7 days
Show all 9Show fewer
- Chronic opioid use to control pain
- Workers compensation and litigation
- BMI > 40
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effectiveness of Particulate Versus Nonparticulate Corticosteroid Injections for the Treatment of Musculoskeletal Conditions
This aims of this study are:
- To determine if particulate or non-particulate corticosteroid injections are more effective at treating pain from musculoskeletal pathologies of the hip, glenohumeral joint, biceps tendon, or subacromial/subdeltoid bursa at 2 weeks, 3 months, or 6 months.
- To determine if there is a significantly different side effect profile between particulate and non-particulate corticosteroids when used for hip, glenohumeral joint, biceps tendon, or subacromial/subdeltoid bursa injections.
Read the detailed description
This will be a single center, prospective, single blind, randomized controlled trial of hip, glenohumeral joint, peri-tendinous biceps brachii, and subacromial/subdeltoid bursa injections comparing the efficacy of particulate (triamcinolone, betamethasone) versus non-particulate (dexamethasone) corticosteroids.
Participants will be recruited for the study by trained physicians and physician extenders at Stanford orthopedic and PM\&R clinics only after they have already opted for corticosteroid injection as a part of their routine medical care. The initial decision to pursue steroid injection will be based entirely on joint decision making between the patient and their medical provider prior to mention of the study.
After consenting, basic demographic data, average numeric pain score (NRS) over the past week, and information on other medical interventions tried for their pain (including medication use, physical therapy, chiropractic care, and massage) will be collected. The participant will then be randomized to receive either a particulate (triamcinolone or betamethasone) or non-particulate (dexamethasone) corticosteroid, both of which are within current standards of care. Ultrasound or fluoroscopic guided injection will then be completed using sterile technique as per current clinic practice.
After the injection, patients will follow up in clinic or over the phone at 2 weeks, 3 months, and 6 months and will be asked their average NRS over the past week, functional questionnaires appropriate to pertinent body parts (WOMAC, ASES, QDASH), other treatments they have tried in the interim, and for any side effects they have experienced. In addition to obtaining outcome measures, the treating physicians may order repeat injections, medications, or refer the subject to surgery, at their discretion based upon the patient's pain and functional limitations. Up to a total of three injections to the same musculoskeletal structure are allowed during the 6 month study period. Any injection into a separate space (i.e. glenohumeral joint followed by subdeltoid bursa) will be considered different structures, and follow up for the new anatomical site will begin at the time of that injection. Data collection and follow up on the previous anatomical injection site will continue on the same timeline. Data on number and timing of repeat injections, surgeries, side effects, and medications will be recorded as part of the study.
- Conditions
- Osteoarthritis, Tendinopathy, Impingement Shoulder
- Being tested
- Triamcinolone or Betamethasone, Dexamethasone
- Keywords
- corticosteroid injection, particulate steroid, non-particulate steroid
- Medical subject headings
- Osteoarthritis, Tendinopathy, Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone or BetamethasoneDrug
Also called Particulate Steroid
Image guided intra-articular, peri-tendinous, or intra-bursal corticosteroid injection
DexamethasoneDrug
Also called Non-Particulate Steroid
Image guided intra-articular, peri-tendinous, or intra-bursal corticosteroid injection
| Study group | Role | What they receive |
|---|---|---|
| Particulate Corticosteroid Injection | Other | Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 10-80mg of triamcinolone or 3-9mg of betamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion. Receives: Drug: Triamcinolone or Betamethasone |
| Non-particulate Corticosteroid Injection | Other | Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 4-10mg of dexamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Average Pain From Baseline
Mean change in pain averaged over last 7 days compared to baseline as rated on 11 point numerical rating scale (NRS, score range from 0-10) with higher values indicating worse outcomes.
Measured: Baseline and at 2 weeks, 3 months, and 6 months post intervention
Number of Participants With ≥50% Decrease in Pain From Baseline
Decrease in pain compared to baseline as rated on 11 point numerical rating scale (NRS, score range from 0-10) with higher values indicating worse outcomes.
Measured: Baseline and at 2 weeks, 3 months, and 6 months post intervention
Secondary outcomes (5)
Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
The WOMAC questionnaire will be used for participants who underwent hip injection. The outcome of interest is the mean change in score compared to baseline. The WOMAC is a 24 item scale with scores ranging from 0 to 96, with higher scores indicating worse outcomes.
Measured: Baseline and at 2 weeks, 3 months, and 6 months post intervention
Change in Quick Disabilities of Arm, Shoulder, and Hand (QDASH)
The QDASH questionnaire will be used for participants who underwent glenohumeral joint, subdeltoid bursa, or peritendinous biceps injection. The outcome of interest is the mean change in score compared to baseline. The QDASH is an 11 item scale with scores ranging from 0 to 100, with higher scores indicating worse outcomes.
Measured: Baseline and at 2 weeks, 3 months, and 6 months post intervention
Change in American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form
The ASES questionnaire will be used for participants who underwent glenohumeral joint, subdeltoid bursa, or peritendinous biceps injection. The outcome of interest is the mean change in score compared to baseline. The ASES is an 11 item scale with scores ranging from 0 to 100, with higher scores indicating better outcomes.
Measured: Baseline and at 2 weeks, 3 months, and 6 months post intervention
Number of Participants With Repeat Corticosteroid Injections
Total number of corticosteroid injections to the specific anatomical site during the study period. The study protocol allows for a maximum of 3 injections during the 6 month study period based on the treating physician's discretion.
Measured: 6 months post initial intervention
Number of Participants Referred for Surgical Intervention (Conversion to Surgery)
Number (%) of participants who were referred for surgical intervention on the specific anatomical site during the study follow up period.
Measured: 6 months post initial intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 Sep 2020
- Primary completion28 May 2021
- Study completion28 May 2021
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Single center, prospective, single blind, randomized controlled trial of hip, glenohumeral joint, biceps tendon, and subacromial bursa injections comparing the efficacy of particulate (triamcinolone, betamethasone) vs non-particulate (dexamethasone) steroids. Participants will be recruited at Stanford orthopedic and PM\&R clinics only after they have already opted for steroid injection as a part of their medical care. They will be randomized to receive either a particulate or non-particulate corticosteroid, then image-guided injection will be completed as per current clinic practice. Patients will follow up in clinic or via phone at 2 weeks, 3 months, and 6 months and will be asked their NRS score, functional questionnaires, other treatments they have tried, and for any side effects experienced. The treating physician may order repeat injections, medications, or refer to surgery, at their discretion. Up to three injections to the same structure are allowed during the study period.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugene Roh, Stanford University
- Investigators
- Eugene Roh, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278833
- Sponsor's protocol ID
- 54336
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2020
- Last updated
- 12 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buchbinder R, Green S, Forbes A, Hall S, Lawler G. Arthrographic joint distension with saline and steroid improves function and reduces pain in patients with painful stiff shoulder: results of a randomised, double blind, placebo controlled trial. Ann Rheum Dis. 2004 Mar;63(3):302-9. doi: 10.1136/ard.2002.004655.
PubMed 14962967Daniels EW, Cole D, Jacobs B, Phillips SF. Existing Evidence on Ultrasound-Guided Injections in Sports Medicine. Orthop J Sports Med. 2018 Feb 22;6(2):2325967118756576. doi: 10.1177/2325967118756576. eCollection 2018 Feb.
PubMed 29511701Dawley JD, Moeller-Bertram T, Wallace MS, Patel PM. Intra-arterial injection in the rat brain: evaluation of steroids used for transforaminal epidurals. Spine (Phila Pa 1976). 2009 Jul 15;34(16):1638-43. doi: 10.1097/BRS.0b013e3181ac0018.
PubMed 19770605Denis I, Claveau G, Filiatrault M, Fugere F, Fortin L. Randomized Double-Blind Controlled Trial Comparing the Effectiveness of Lumbar Transforaminal Epidural Injections of Particulate and Nonparticulate Corticosteroids for Lumbosacral Radicular Pain. Pain Med. 2015 Sep;16(9):1697-708. doi: 10.1111/pme.12846. Epub 2015 Jun 22.
PubMed 26095339Derby R, Lee SH, Date ES, Lee JH, Lee CH. Size and aggregation of corticosteroids used for epidural injections. Pain Med. 2008 Mar;9(2):227-34. doi: 10.1111/j.1526-4637.2007.00341.x.
PubMed 18298706Dreyfuss P, Baker R, Bogduk N. Comparative effectiveness of cervical transforaminal injections with particulate and nonparticulate corticosteroid preparations for cervical radicular pain. Pain Med. 2006 May-Jun;7(3):237-42. doi: 10.1111/j.1526-4637.2006.00162.x.
PubMed 16712623Hajialilo M, Ghorbanihaghjo A, Valaee L, Kolahi S, Rashtchizadeh N, Amirkhiz MB, Malekmahdavi I, Khabbazi A. A double-blind randomized comparative study of triamcinolone hexacetonide and dexamethasone intra-articular injection for the treatment of knee joint arthritis in rheumatoid arthritis. Clin Rheumatol. 2016 Dec;35(12):2887-2891. doi: 10.1007/s10067-016-3397-4. Epub 2016 Aug 29.
PubMed 27572327Hong JY, Yoon SH, Moon DJ, Kwack KS, Joen B, Lee HY. Comparison of high- and low-dose corticosteroid in subacromial injection for periarticular shoulder disorder: a randomized, triple-blind, placebo-controlled trial. Arch Phys Med Rehabil. 2011 Dec;92(12):1951-60. doi: 10.1016/j.apmr.2011.06.033. Epub 2011 Oct 25.
PubMed 22030233Kennedy DJ, Plastaras C, Casey E, Visco CJ, Rittenberg JD, Conrad B, Sigler J, Dreyfuss P. Comparative effectiveness of lumbar transforaminal epidural steroid injections with particulate versus nonparticulate corticosteroids for lumbar radicular pain due to intervertebral disc herniation: a prospective, randomized, double-blind trial. Pain Med. 2014 Apr;15(4):548-55. doi: 10.1111/pme.12325. Epub 2014 Jan 2.
PubMed 24393129Laemmel E, Segal N, Mirshahi M, Azzazene D, Le Marchand S, Wybier M, Vicaut E, Laredo JD. Deleterious Effects of Intra-arterial Administration of Particulate Steroids on Microvascular Perfusion in a Mouse Model. Radiology. 2016 Jun;279(3):731-40. doi: 10.1148/radiol.2015142746. Epub 2016 Jan 13.
PubMed 26761719Lambert RG, Hutchings EJ, Grace MG, Jhangri GS, Conner-Spady B, Maksymowych WP. Steroid injection for osteoarthritis of the hip: a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2007 Jul;56(7):2278-87. doi: 10.1002/art.22739.
PubMed 17599747Lee HJ, Lim KB, Kim DY, Lee KT. Randomized controlled trial for efficacy of intra-articular injection for adhesive capsulitis: ultrasonography-guided versus blind technique. Arch Phys Med Rehabil. 2009 Dec;90(12):1997-2002. doi: 10.1016/j.apmr.2009.07.025.
PubMed 19969160Mehta P, Syrop I, Singh JR, Kirschner J. Systematic Review of the Efficacy of Particulate Versus Nonparticulate Corticosteroids in Epidural Injections. PM R. 2017 May;9(5):502-512. doi: 10.1016/j.pmrj.2016.11.008. Epub 2016 Nov 30.
PubMed 27915069Okubadejo GO, Talcott MR, Schmidt RE, Sharma A, Patel AA, Mackey RB, Guarino AH, Moran CJ, Riew KD. Perils of intravascular methylprednisolone injection into the vertebral artery. An animal study. J Bone Joint Surg Am. 2008 Sep;90(9):1932-8. doi: 10.2106/JBJS.G.01182.
PubMed 18762654Ring D, Lozano-Calderon S, Shin R, Bastian P, Mudgal C, Jupiter J. A prospective randomized controlled trial of injection of dexamethasone versus triamcinolone for idiopathic trigger finger. J Hand Surg Am. 2008 Apr;33(4):516-22; discussion 523-4. doi: 10.1016/j.jhsa.2008.01.001.
PubMed 18406955
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Particulate Versus Nonparticulate Corticosteroid Injections for the Treatment of Musculoskeletal Conditions
- ClinicalTrials.gov ID
- NCT04278833
- Acronym / sponsor ID
- 54336
- Conditions
- Osteoarthritis, Tendinopathy, Impingement Shoulder
- Keywords
- corticosteroid injection, particulate steroid, non-particulate steroid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Posted 12 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This aims of this study are:
- To determine if particulate or non-particulate corticosteroid injections are more effective at treating pain from musculoskeletal pathologies of the hip, glenohumeral joint, biceps tendon, or subacromial/subdeltoid bursa at 2 weeks, 3 months, or 6 months.
- To determine if there is a significantly different side effect profile between particulate and non-particulate corticosteroids when used for hip, glenohumeral joint, biceps tendon, or subacromial/subdeltoid bursa injections.
Detailed description
This will be a single center, prospective, single blind, randomized controlled trial of hip, glenohumeral joint, peri-tendinous biceps brachii, and subacromial/subdeltoid bursa injections comparing the efficacy of particulate (triamcinolone, betamethasone) versus non-particulate (dexamethasone) corticosteroids.
Participants will be recruited for the study by trained physicians and physician extenders at Stanford orthopedic and PM\&R clinics only after they have already opted for corticosteroid injection as a part of their routine medical care. The initial decision to pursue steroid injection will be based entirely on joint decision making between the patient and their medical provider prior to mention of the study.
After consenting, basic demographic data, average numeric pain score (NRS) over the past week, and information on other medical interventions tried for their pain (including medication use, physical therapy, chiropractic care, and massage) will be collected. The participant will then be randomized to receive either a particulate (triamcinolone or betamethasone) or non-particulate (dexamethasone) corticosteroid, both of which are within current standards of care. Ultrasound or fluoroscopic guided injection will then be completed using sterile technique as per current clinic practice.
After the injection, patients will follow up in clinic or over the phone at 2 weeks, 3 months, and 6 months and will be asked their average NRS over the past week, functional questionnaires appropriate to pertinent body parts (WOMAC, ASES, QDASH), other treatments they have tried in the interim, and for any side effects they have experienced. In addition to obtaining outcome measures, the treating physicians may order repeat injections, medications, or refer the subject to surgery, at their discretion based upon the patient's pain and functional limitations. Up to a total of three injections to the same musculoskeletal structure are allowed during the 6 month study period. Any injection into a separate space (i.e. glenohumeral joint followed by subdeltoid bursa) will be considered different structures, and follow up for the new anatomical site will begin at the time of that injection. Data collection and follow up on the previous anatomical injection site will continue on the same timeline. Data on number and timing of repeat injections, surgeries, side effects, and medications will be recorded as part of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single center, prospective, single blind, randomized controlled trial of hip, glenohumeral joint, biceps tendon, and subacromial bursa injections comparing the efficacy of particulate (triamcinolone, betamethasone) vs non-particulate (dexamethasone) steroids. Participants will be recruited at Stanford orthopedic and PM\&R clinics only after they have already opted for steroid injection as a part of their medical care. They will be randomized to receive either a particulate or non-particulate corticosteroid, then image-guided injection will be completed as per current clinic practice. Patients will follow up in clinic or via phone at 2 weeks, 3 months, and 6 months and will be asked their NRS score, functional questionnaires, other treatments they have tried, and for any side effects experienced. The treating physician may order repeat injections, medications, or refer to surgery, at their discretion. Up to three injections to the same structure are allowed during the study period.
| Arm | Type | Receives |
|---|---|---|
| Particulate Corticosteroid Injection | Other | Drug: Triamcinolone or BetamethasoneIntra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 10-80mg of triamcinolone or 3-9mg of betamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion. |
| Non-particulate Corticosteroid Injection | Other | Drug: DexamethasoneIntra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 4-10mg of dexamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than or equal to 18
- Ability to provide informed consent
- Capable of complying with the outcome instruments used
- Capable of attending all planned follow up visits
- Patient is deemed appropriate for intra-articular hip, glenohumeral, peri-tendinous biceps, or subdeltoid bursa corticosteroid injection by their treating physician for the treatment of painful musculoskeletal condition
Key exclusion criteria (9 listed)
- Unclear diagnosis
- Pregnancy
- Incarcerated patients
- Prior corticosteroid injection into the same anatomical site within the last 3 months
- Prior prosthetic surgery on the joint
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 |
|---|---|---|
| Triamcinolone or BetamethasoneAlso: Particulate SteroidImage guided intra-articular, peri-tendinous, or intra-bursal corticosteroid injection | Drug | Particulate Corticosteroid Injection |
| DexamethasoneAlso: Non-Particulate SteroidImage guided intra-articular, peri-tendinous, or intra-bursal corticosteroid injection | Drug | Non-particulate Corticosteroid Injection |
Primary outcome
Mean Change in Average Pain From Baseline
Time frame: Baseline and at 2 weeks, 3 months, and 6 months post intervention
Mean change in pain averaged over last 7 days compared to baseline as rated on 11 point numerical rating scale (NRS, score range from 0-10) with higher values indicating worse outcomes.
Number of Participants With ≥50% Decrease in Pain From Baseline
Time frame: Baseline and at 2 weeks, 3 months, and 6 months post intervention
Decrease in pain compared to baseline as rated on 11 point numerical rating scale (NRS, score range from 0-10) with higher values indicating worse outcomes.
5 secondary outcomes
Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
Time frame: Baseline and at 2 weeks, 3 months, and 6 months post intervention
Change in Quick Disabilities of Arm, Shoulder, and Hand (QDASH)
Time frame: Baseline and at 2 weeks, 3 months, and 6 months post intervention
Change in American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form
Time frame: Baseline and at 2 weeks, 3 months, and 6 months post intervention
Number of Participants With Repeat Corticosteroid Injections
Time frame: 6 months post initial intervention
Number of Participants Referred for Surgical Intervention (Conversion to Surgery)
Time frame: 6 months post initial intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14962967Buchbinder R, Green S, Forbes A, Hall S, Lawler G. Arthrographic joint distension with saline and steroid improves function and reduces pain in patients with painful stiff shoulder: results of a randomised, double blind, placebo controlled trial. Ann Rheum Dis. 2004 Mar;63(3):302-9. doi: 10.1136/ard.2002.004655.
- Background: PubMed 29511701Daniels EW, Cole D, Jacobs B, Phillips SF. Existing Evidence on Ultrasound-Guided Injections in Sports Medicine. Orthop J Sports Med. 2018 Feb 22;6(2):2325967118756576. doi: 10.1177/2325967118756576. eCollection 2018 Feb.
- Background: PubMed 19770605Dawley JD, Moeller-Bertram T, Wallace MS, Patel PM. Intra-arterial injection in the rat brain: evaluation of steroids used for transforaminal epidurals. Spine (Phila Pa 1976). 2009 Jul 15;34(16):1638-43. doi: 10.1097/BRS.0b013e3181ac0018.
- Background: PubMed 26095339Denis I, Claveau G, Filiatrault M, Fugere F, Fortin L. Randomized Double-Blind Controlled Trial Comparing the Effectiveness of Lumbar Transforaminal Epidural Injections of Particulate and Nonparticulate Corticosteroids for Lumbosacral Radicular Pain. Pain Med. 2015 Sep;16(9):1697-708. doi: 10.1111/pme.12846. Epub 2015 Jun 22.
- Background: PubMed 18298706Derby R, Lee SH, Date ES, Lee JH, Lee CH. Size and aggregation of corticosteroids used for epidural injections. Pain Med. 2008 Mar;9(2):227-34. doi: 10.1111/j.1526-4637.2007.00341.x.
- Background: PubMed 16712623Dreyfuss P, Baker R, Bogduk N. Comparative effectiveness of cervical transforaminal injections with particulate and nonparticulate corticosteroid preparations for cervical radicular pain. Pain Med. 2006 May-Jun;7(3):237-42. doi: 10.1111/j.1526-4637.2006.00162.x.
- Background: PubMed 27572327Hajialilo M, Ghorbanihaghjo A, Valaee L, Kolahi S, Rashtchizadeh N, Amirkhiz MB, Malekmahdavi I, Khabbazi A. A double-blind randomized comparative study of triamcinolone hexacetonide and dexamethasone intra-articular injection for the treatment of knee joint arthritis in rheumatoid arthritis. Clin Rheumatol. 2016 Dec;35(12):2887-2891. doi: 10.1007/s10067-016-3397-4. Epub 2016 Aug 29.
- Background: PubMed 22030233Hong JY, Yoon SH, Moon DJ, Kwack KS, Joen B, Lee HY. Comparison of high- and low-dose corticosteroid in subacromial injection for periarticular shoulder disorder: a randomized, triple-blind, placebo-controlled trial. Arch Phys Med Rehabil. 2011 Dec;92(12):1951-60. doi: 10.1016/j.apmr.2011.06.033. Epub 2011 Oct 25.
- Background: PubMed 24393129Kennedy DJ, Plastaras C, Casey E, Visco CJ, Rittenberg JD, Conrad B, Sigler J, Dreyfuss P. Comparative effectiveness of lumbar transforaminal epidural steroid injections with particulate versus nonparticulate corticosteroids for lumbar radicular pain due to intervertebral disc herniation: a prospective, randomized, double-blind trial. Pain Med. 2014 Apr;15(4):548-55. doi: 10.1111/pme.12325. Epub 2014 Jan 2.
- Background: PubMed 26761719Laemmel E, Segal N, Mirshahi M, Azzazene D, Le Marchand S, Wybier M, Vicaut E, Laredo JD. Deleterious Effects of Intra-arterial Administration of Particulate Steroids on Microvascular Perfusion in a Mouse Model. Radiology. 2016 Jun;279(3):731-40. doi: 10.1148/radiol.2015142746. Epub 2016 Jan 13.
- Background: PubMed 17599747Lambert RG, Hutchings EJ, Grace MG, Jhangri GS, Conner-Spady B, Maksymowych WP. Steroid injection for osteoarthritis of the hip: a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2007 Jul;56(7):2278-87. doi: 10.1002/art.22739.
- Background: PubMed 19969160Lee HJ, Lim KB, Kim DY, Lee KT. Randomized controlled trial for efficacy of intra-articular injection for adhesive capsulitis: ultrasonography-guided versus blind technique. Arch Phys Med Rehabil. 2009 Dec;90(12):1997-2002. doi: 10.1016/j.apmr.2009.07.025.
- 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.
Eugene Roh, MD principal investigator
Stanford 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 Triamcinolone or Betamethasone and Dexamethasone in people with Osteoarthritis and Tendinopathy, run by Stanford University at 1 site in United States.
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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 12 Feb 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 12 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in Average Pain From Baseline (time frame: Baseline and at 2 weeks, 3 months, and 6 months post intervention). The study lists 2 primary outcomes in all. 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 NCT04278833, which also lists 17 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 12 Feb 2025.