Trigger FingerPhase 4NCT04900220
Differences in Flare Reaction Incidence and Intensity Following Trigger Finger Injections
A Phase 4 study testing Betamethasone and Methylprednisolone in people with Trigger Finger, run by West Virginia University at 2 sites in United States.
Trial summary
Two common corticosteroids used for trigger finger treatment are betamethasone and methylprednisolone. Both injections are effective in treating trigger finger and the decision of which to use in treatment is currently a matter of the current practice and physician preference. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigger Finger
- What is being tested?
- Betamethasone and Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Sep 2021to 10 Apr 2023
- 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
- Single trigger injection
- First time for the digit
- No prior surgery on digit
Who cannot join
- Current oral steroid use
- Rheumatoid arthritis
- More than one single digit involved
- Previous injection in same digit
- Prior surgery on same digit
- Other injections in the same clinic on the same day
Trial locations and contacts
2 sites in 1 country.
United States2 sites
WVU Medicine University Town Center
Morgantown, West Virginia, 26501
Ruby Memorial Hospital or Other WVU Healthcare Site
Morgantown, West Virginia, 26506
About this study
Official title: Investigating Differences in Flare Reaction Incidence and Intensity Following Trigger Finger Injections Using Betamethasone and Methylprednisolone
Two common corticosteroids used for trigger finger treatment are betamethasone and methylprednisolone. Both injections are effective in treating trigger finger and the decision of which to use in treatment is currently a matter of the current practice and physician preference. The goal through this randomized trial is to see whether there is a difference between these two corticosteroids in inducing flare reactions and if there are any differences in the peak level of pain and their duration. Findings indicating a statistically significant difference in the incidence and/or intensity of the flare reactions would be clinically significant and would be evidence supporting the switch of current practice to one corticosteroid over the other.
Read the detailed description
Corticosteroid injections are effective non-surgical approach to treating trigger finger (stenosing tenosynovitis) with success rates reported as high as 92% after just one injection [1]. Among their side effects is a post-injection flare of increased pain that is attributed to crystal-induced synovitis. Reports of these flares in the literature have been rare. Recent evidence their incidence can be as high as 33%. The investigators feel it is a more common clinical issue than traditionally reported and it would be beneficial to control and reduce their incidence if possible.
Two common corticosteroids used for trigger finger treatment are betamethasone and methylprednisolone. Both injections are effective in treating trigger finger and the decision of which to use in treatment is currently a matter of the current practice and physician preference. There is no literature comparing the side effects, specifically flare reactions between these two treatments. The goal through this randomized trial is to see whether there is a difference between these two corticosteroids in inducing flare reactions and if there are any differences in the peak level of pain and their duration.
This is a double-blinded randomized trial enrolling patients into one of the two treatment groups. The volume of the doses will be standardized to 1 cc of either methylprednisolone (40 mg) or betamethasone (6 mg). Patients, who meet the inclusion criteria, will be instructed to complete a visual analog scale (VAS) of their pain (1-10) prior to the injection, during the injection and once a day for the following 7 days after the injection. The investigators estimate that a minimum of 30 patients in each group will be needed to achieve a minimum of 80% power and 0.05 significance. The incidence, intensity, time to peak and time to resolution of the flare reactions (defined as a 2-point increase from pre-injection pain) will be assessed and compared between the two groups. Findings indicating a statistically significant difference in the incidence and/or intensity of the flare reactions would be clinically significant and would be evidence supporting the switch of current practice to one corticosteroid over the other.
- Conditions
- Trigger Finger
- Being tested
- Betamethasone, Methylprednisolone
- Medical subject headings
- Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetamethasoneDrug
The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of betamethasone (6 mg)
The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of methylprednisolone (40 mg)
| Study group | Role | What they receive |
|---|---|---|
| Betamethasone | Active comparator | betamethasone Receives: Drug: Betamethasone |
| Methylprednisolone | Active comparator | methylprednisolone Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Pain
Recorded when subject reports pain. Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
Measured: Up to 7 days
Intensity of Pain
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
Measured: Up to 7 days
Incidence of Flare Reaction
Number of patients having a severe flare reaction
Measured: From baseline up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start15 Sep 2021
- Primary completion27 Dec 2022
- Study completion10 Apr 2023
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.
- Other trials for Trigger FingerStudies of the same condition, open and under way.
- More trials run by West Virginia 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
- This is a double-blinded randomized trial enrolling patients into one of the two treatment groups. The volume of the doses of steroid to be given will be standardized to 1 cc of either methylprednisolone (40 mg) or betamethasone (6 mg). We will instruct patients who meet the inclusion criteria to complete a visual analog scale (VAS) of their pain (1-10) prior to the injection, immediately after the injection, five minutes after the injection, and once a day for a minimum of 7 days after the injection. The incidence, intensity, time to peak and time to resolution of the flare reactions (defined as a 2-point increase from pre-injection pain) will be assessed and compared between the two groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shafic Sraj, MD, West Virginia University
- Investigators
- Shatic Sraj, MD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900220
- Sponsor's protocol ID
- 2103263450
- Status last verified
- May 2023
- First submitted
- 20 May 2021
- Last updated
- 23 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Differences in Flare Reaction Incidence and Intensity Following Trigger Finger Injections Using Betamethasone and Methylprednisolone
- ClinicalTrials.gov ID
- NCT04900220
- Acronym / sponsor ID
- 2103263450
- Conditions
- Trigger Finger
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 27 Dec 2022 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 25 May 2021 (actual)
- Results
- Posted 23 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two common corticosteroids used for trigger finger treatment are betamethasone and methylprednisolone. Both injections are effective in treating trigger finger and the decision of which to use in treatment is currently a matter of the current practice and physician preference. The goal through this randomized trial is to see whether there is a difference between these two corticosteroids in inducing flare reactions and if there are any differences in the peak level of pain and their duration. Findings indicating a statistically significant difference in the incidence and/or intensity of the flare reactions would be clinically significant and would be evidence supporting the switch of current practice to one corticosteroid over the other.
Detailed description
Corticosteroid injections are effective non-surgical approach to treating trigger finger (stenosing tenosynovitis) with success rates reported as high as 92% after just one injection [1]. Among their side effects is a post-injection flare of increased pain that is attributed to crystal-induced synovitis. Reports of these flares in the literature have been rare. Recent evidence their incidence can be as high as 33%. The investigators feel it is a more common clinical issue than traditionally reported and it would be beneficial to control and reduce their incidence if possible.
Two common corticosteroids used for trigger finger treatment are betamethasone and methylprednisolone. Both injections are effective in treating trigger finger and the decision of which to use in treatment is currently a matter of the current practice and physician preference. There is no literature comparing the side effects, specifically flare reactions between these two treatments. The goal through this randomized trial is to see whether there is a difference between these two corticosteroids in inducing flare reactions and if there are any differences in the peak level of pain and their duration.
This is a double-blinded randomized trial enrolling patients into one of the two treatment groups. The volume of the doses will be standardized to 1 cc of either methylprednisolone (40 mg) or betamethasone (6 mg). Patients, who meet the inclusion criteria, will be instructed to complete a visual analog scale (VAS) of their pain (1-10) prior to the injection, during the injection and once a day for the following 7 days after the injection. The investigators estimate that a minimum of 30 patients in each group will be needed to achieve a minimum of 80% power and 0.05 significance. The incidence, intensity, time to peak and time to resolution of the flare reactions (defined as a 2-point increase from pre-injection pain) will be assessed and compared between the two groups. Findings indicating a statistically significant difference in the incidence and/or intensity of the flare reactions would be clinically significant and would be evidence supporting the switch of current practice to one corticosteroid over the other.
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
- This is a double-blinded randomized trial enrolling patients into one of the two treatment groups. The volume of the doses of steroid to be given will be standardized to 1 cc of either methylprednisolone (40 mg) or betamethasone (6 mg). We will instruct patients who meet the inclusion criteria to complete a visual analog scale (VAS) of their pain (1-10) prior to the injection, immediately after the injection, five minutes after the injection, and once a day for a minimum of 7 days after the injection. The incidence, intensity, time to peak and time to resolution of the flare reactions (defined as a 2-point increase from pre-injection pain) will be assessed and compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Betamethasone | Active comparator | Drug: Betamethasonebetamethasone |
| Methylprednisolone | Active comparator | Drug: Methylprednisolonemethylprednisolone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Single trigger injection
- First time for the digit
- No prior surgery on digit
Key exclusion criteria (6 listed)
- Current oral steroid use
- Rheumatoid arthritis
- More than one single digit involved
- Previous injection in same digit
- Prior surgery on same digit
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 |
|---|---|---|
| BetamethasoneThe volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of betamethasone (6 mg) | Drug | Betamethasone |
| MethylprednisoloneThe volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of methylprednisolone (40 mg) | Drug | Methylprednisolone |
Primary outcome
Incidence of Pain
Time frame: Up to 7 days
Recorded when subject reports pain. Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
Intensity of Pain
Time frame: Up to 7 days
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
Incidence of Flare Reaction
Time frame: From baseline up to 7 days
Number of patients having a severe flare reaction
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
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Enrolling by invitation
A Comparison of Metacarpophalangeal Joint Blocking Splint With Relative Motion Extension Splint for Trigger Finger
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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.
Shatic Sraj, MD principal investigator
West Virginia University
2 sites 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 and Methylprednisolone in people with Trigger Finger, run by West Virginia University at 2 sites 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 3 inclusion and 6 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 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 23 Jun 2023). 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?
Incidence of Pain (time frame: Up to 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2023.