A Phase 4 interventional study of Triamcinolone Acetonide 40mg/mL and Triamcinolone Acetonide 10mg/mL in Trigger Finger, sponsored by University of Missouri-Columbia. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-26.
Sponsored by University of Missouri-Columbia · Phase 4, Interventional, and Treatment
Trigger finger is a common cause of hand pain and dysfunction. Its due to chronic inflammation of the flexor tendon that leads to a pulley system mismatch. Historically it has been managed either conservatively with corticosteroid injections or through a surgical release of the A1 pulley. Several corticosteroids have been used for injection- dexamethasone, methylprednisolone, triamcinolone, betamethasone, paramethasone, etc. The purpose of out study is to determine if a 0.5 cc injection of Triamcinolone 40 mg/mL will be the most effective steroid injection for the non-surgical treatment. Approximately 200 subjects will be enrolled and randomized to one of three treatment arms: Triamcinolone 40mg/mL, Triamcinolone 10mg/mL and Soluble dexamethasone 4mg/mL. Treatment success will be defined as lack of conversion to surgical treatment, or no desire to proceed with surgery during study period (3 months).
Idiopathic stenosing tenosynovitis of the digits, more commonly known as "trigger finger", is a common cause of hand pain and dysfunction. Many previous studies have described the pathophysiology of this condition and it can be summarized as inflammation of the flexor tendons leading to a size mismatch between the tendon and the flexor pulley system. By far the most common location of this mismatch is at the A1 pulley.
The current mainstay of treatment has been:
Several corticosteroids have been used for injection- dexamethasone, methylprednisolone, triamcinolone, betamethasone, paramethasone, etc. Less commonly used treatment strategies have included: topical NSAIDs and extracorporeal shock therapy. The typical progression of treatment is one or two steroid injections and then surgical release if injections have failed.
To our knowledge, there have been no head to head comparison studies of the efficacy of different corticosteroid formulations in preventing conversion to surgical treatment. In our study, the investigators will look at the efficacy of two of the most commonly used steroids: triamcinolone and dexamethasone.
Objectives:
Primary outcome: Treatment success, defined as lack of conversion to surgical treatment, or no desire to proceed with surgery during study period (3 months).
Secondary outcomes: Grade of triggering (Green classification of trigger finger severity1), QuickDASH (Disabilities of the Arm, Shoulder and Hand) and PROMIS Upper Extremity scores, VAS.
Inclusion/Exclusion:
Inclusion criteria:
Exclusion criteria:
Study Procedures/Methods:
Enrollment/Randomization/Treatment Visit:
Eligible patients presenting with primary flexor tenosynovitis will be enrolled on a voluntary basis. Prior to the injection, subjects will be asked to complete the PROMIS and QuickDASH surveys to collect data at baseline.
Enrolled patients will be randomized to one of three treatment arms:
Each study patient will receive the appropriate corticosteroid injection in the affected digit(s), consisting of a 1:1 mixture of 1% lidocaine plain and corticosteroid, total volume 1cc.
Blinding:
Syringes will be prepared and masked with opaque tape by the clinic nurses, thus providing blinding for providers administering the injection.
Follow-Up/Clinic Visits:
Subjects will be re-evaluated at 6 weeks post-injection and, if still symptomatic, will undergo a second injection of the same corticosteroid solution. At final follow-up (12 weeks), symptomatic patients who have failed treatment after 2 injections will be offered surgical release of the A1 pulley. Subjects who refuse a second injection at 6 weeks follow-up will be offered surgery, and the reason for refusal (treatment failure) will be recorded.
The visits and all research activity will be outlined below:
6 Week Follow-Up:
Objective Measures:
Subjective Measures:
VAS Second Corticosteroid injection (if subject still symptomatic)
12 Week (3 Month) Follow-Up (if applicable):
Objective Measures:
Subjective Measures:
6 Month Follow-Up: The patient will be contacted to check on the status of their condition. If they are still experiencing a degree of triggering they will be advised by their physician to return to clinic for a standard of care visit. If they are no longer experiencing triggering, they will be asked to complete a survey over the phone or online only.
Specimen Collection: If a patient is recommended to undergo surgery at the end of the study, the tenosynovium that is normally resected and discarded after surgery will be collected for analysis. After collection these tissues and data will be identified from the patient and assigned a number for use in study analysis. The investigators seek to only collect tissues from patients that are normally removed and discarded during trigger finger release procedures. None of the patients will undergo additional surgical procedures for the collection of tissues in this study. For simplification purposes, potential subjects must agree to the collection of these specimens to participate in the study, even if they do not end up needing surgical intervention.
93 studies on the registry are indexed under Trigger Finger Disorder; 22 are open to participants now.
This study's enrollment of 95 is above the median of 66 across 75 interventional studies indexed under Trigger Finger Disorder.
Browse Trigger Finger Disorder studies →University of Missouri-Columbia is the lead sponsor of 365 studies on the registry; 69 are open to participants now.
Of its 43 completed or terminated interventional studies of FDA-regulated products, 29 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A corticosteroid injection of Triamcinolone 40mg/mL will be given to subjects to treat their symptoms of trigger finger.
Drug: Triamcinolone Acetonide 40mg/mL
A corticosteroid injection of Triamcinolone 10mg/mL will be given to subjects to treat their symptoms of trigger finger.
Drug: Triamcinolone Acetonide 10mg/mL
A corticosteroid injection of Soluble Dexamethasone 4mg/mL will be given to subjects to treat their symptoms of trigger finger.
Drug: Dexamethasone 4 mg/ml
Drug page: Triamcinolone Acetonide
Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
Drug page: Triamcinolone Acetonide
Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
Drug page: Dexamethasone
Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
Disabilities of the Arm, Shoulder and Hand (DASH)
The patient will be asked to complete a questionnaire with questions related to their hand. Their answers will be scored on a scale of 0-100 with 0 being no disability and 100 being the highest level of disability.
Time frame: 6 Weeks
Disabilities of the Arm, Shoulder and Hand (DASH)
The patient will be asked to complete a questionnaire with questions related to their hand. Their answers will be scored on a scale of 0-100 with 0 being no disability and 100 being the highest level of disability.
Time frame: 12 Weeks
Disabilities of the Arm, Shoulder and Hand (DASH)
The patient will be asked to complete a questionnaire with questions related to their hand. Their answers will be scored on a scale of 0-100 with 0 being no disability and 100 being the highest level of disability.
Time frame: 6 Month
Pain Visual Analog Score (VAS)
The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.
Time frame: 6 Weeks
Pain Visual Analog Score (VAS)
The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.
Time frame: 12 Weeks
Pain Visual Analog Score (VAS)
The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.
Time frame: 6 Month
Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores
PROMIS Physical Function - Upper Extremity is a self-reported performance measure assessing physical function of the upper extremity focusing on nine activities that require use of the upper extremity including shoulder, arm, and hand activities. Responses are as follows: 5 = Without any difficulty; 4 = With a little difficulty; 3=With some difficulty; 2=With much difficulty; and 1=Unable to do. The PROMIS Upper Extremity assessment evaluates upper extremity function, with raw scores typically ranging from 8 to 40, depending on the specific form used. These raw scores are converted to T-scores using a standardized table, with a mean of 50 and a standard deviation of 10. These T-scores range from 15 to 61. A higher T-score indicates better upper extremity function, while a lower T-score signifies greater impairment.
Time frame: 6 Weeks
Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores
PROMIS Physical Function - Upper Extremity is a self-reported performance measure assessing physical function of the upper extremity focusing on nine activities that require use of the upper extremity including shoulder, arm, and hand activities. Responses are as follows: 5 = Without any difficulty; 4 = With a little difficulty; 3=With some difficulty; 2=With much difficulty; and 1=Unable to do. The PROMIS Upper Extremity assessment evaluates upper extremity function, with raw scores typically ranging from 8 to 40, depending on the specific form used. These raw scores are converted to T-scores using a standardized table, with a mean of 50 and a standard deviation of 10. These T-scores range from 15 to 61. A higher T-score indicates better upper extremity function, while a lower T-score signifies greater impairment.
Time frame: 12 Weeks
Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores
PROMIS Physical Function - Upper Extremity is a self-reported performance measure assessing physical function of the upper extremity focusing on nine activities that require use of the upper extremity including shoulder, arm, and hand activities. Responses are as follows: 5 = Without any difficulty; 4 = With a little difficulty; 3=With some difficulty; 2=With much difficulty; and 1=Unable to do. The PROMIS Upper Extremity assessment evaluates upper extremity function, with raw scores typically ranging from 8 to 40, depending on the specific form used. These raw scores are converted to T-scores using a standardized table, with a mean of 50 and a standard deviation of 10. These T-scores range from 15 to 61. A higher T-score indicates better upper extremity function, while a lower T-score signifies greater impairment.
Time frame: 6 Month
| Milestone | Triamcinolone 40mg/mL | Triamcinolone 10mg/mL | Soluble Dexamethasone 4mg/mL |
|---|---|---|---|
| Started | 24 | 43 | 28 |
| Completed | 24 | 43 | 28 |
| Not completed | 0 | 0 | 0 |
The patient will be asked to complete a questionnaire with questions related to their hand. Their answers will be scored on a scale of 0-100 with 0 being no disability and 100 being the highest level of disability.
| score on a scale | Triamcinolone 40mg/mL | Triamcinolone 10mg/mL | Soluble Dexamethasone 4mg/mL |
|---|---|---|---|
| Disabilities of the Arm, Shoulder and Hand (DASH) | 12.69 ± 19.87 | 18.69 ± 18.73 | 24.72 ± 13.74 |
The patient will be asked to complete a questionnaire with questions related to their hand. Their answers will be scored on a scale of 0-100 with 0 being no disability and 100 being the highest level of disability.
| score on a scale | Triamcinolone 40mg/mL | Triamcinolone 10mg/mL | Soluble Dexamethasone 4mg/mL |
|---|---|---|---|
| Disabilities of the Arm, Shoulder and Hand (DASH) | 17.66 ± 19.88 | 18.09 ± 17.71 | 23.38 ± 22.91 |
The patient will be asked to complete a questionnaire with questions related to their hand. Their answers will be scored on a scale of 0-100 with 0 being no disability and 100 being the highest level of disability.
| score on a scale | Triamcinolone 40mg/mL | Triamcinolone 10mg/mL | Soluble Dexamethasone 4mg/mL |
|---|---|---|---|
| Disabilities of the Arm, Shoulder and Hand (DASH) | 22.73 ± 19.53 | 22.12 ± 20.55 | 13.64 ± 16.24 |
The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.
| score on a scale | Triamcinolone 40mg/mL | Triamcinolone 10mg/mL | Soluble Dexamethasone 4mg/mL |
|---|---|---|---|
| Pain Visual Analog Score (VAS) | 1.08 ± 2.15 | 1.33 ± 2.2 | 2.04 ± 2.09 |
The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.
| score on a scale | Triamcinolone 40mg/mL | Triamcinolone 10mg/mL | Soluble Dexamethasone 4mg/mL |
|---|---|---|---|
| Pain Visual Analog Score (VAS) | 1.15 ± 1.91 | 2.38 ± 2.37 | 3.33 ± 3.22 |
The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.
| score on a scale | Triamcinolone 40mg/mL | Triamcinolone 10mg/mL | Soluble Dexamethasone 4mg/mL |
|---|---|---|---|
| Pain Visual Analog Score (VAS) | 1.53 ± 1.46 | 1.97 ± 2.41 | 1.38 ± 2.13 |
PROMIS Physical Function - Upper Extremity is a self-reported performance measure assessing physical function of the upper extremity focusing on nine activities that require use of the upper extremity including shoulder, arm, and hand activities. Responses are as follows: 5 = Without any difficulty; 4 = With a little difficulty; 3=With some difficulty; 2=With much difficulty; and 1=Unable to do. The PROMIS Upper Extremity assessment evaluates upper extremity function, with raw scores typically ranging from 8 to 40, depending on the specific form used. These raw scores are converted to T-scores using a standardized table, with a mean of 50 and a standard deviation of 10. These T-scores range from 15 to 61. A higher T-score indicates better upper extremity function, while a lower T-score signifies greater impairment.
| score on a scale | Triamcinolone 40mg/mL | Triamcinolone 10mg/mL | Soluble Dexamethasone 4mg/mL |
|---|---|---|---|
| Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores | 48.24 ± 13.45 | 44.49 ± 11.89 | 37.55 ± 8.98 |
PROMIS Physical Function - Upper Extremity is a self-reported performance measure assessing physical function of the upper extremity focusing on nine activities that require use of the upper extremity including shoulder, arm, and hand activities. Responses are as follows: 5 = Without any difficulty; 4 = With a little difficulty; 3=With some difficulty; 2=With much difficulty; and 1=Unable to do. The PROMIS Upper Extremity assessment evaluates upper extremity function, with raw scores typically ranging from 8 to 40, depending on the specific form used. These raw scores are converted to T-scores using a standardized table, with a mean of 50 and a standard deviation of 10. These T-scores range from 15 to 61. A higher T-score indicates better upper extremity function, while a lower T-score signifies greater impairment.
| score on a scale | Triamcinolone 40mg/mL | Triamcinolone 10mg/mL | Soluble Dexamethasone 4mg/mL |
|---|---|---|---|
| Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores | 48.28 ± 12.09 | 44.82 ± 11.68 | 43.44 ± 12.4 |
PROMIS Physical Function - Upper Extremity is a self-reported performance measure assessing physical function of the upper extremity focusing on nine activities that require use of the upper extremity including shoulder, arm, and hand activities. Responses are as follows: 5 = Without any difficulty; 4 = With a little difficulty; 3=With some difficulty; 2=With much difficulty; and 1=Unable to do. The PROMIS Upper Extremity assessment evaluates upper extremity function, with raw scores typically ranging from 8 to 40, depending on the specific form used. These raw scores are converted to T-scores using a standardized table, with a mean of 50 and a standard deviation of 10. These T-scores range from 15 to 61. A higher T-score indicates better upper extremity function, while a lower T-score signifies greater impairment.
| score on a scale | Triamcinolone 40mg/mL | Triamcinolone 10mg/mL | Soluble Dexamethasone 4mg/mL |
|---|---|---|---|
| Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores | 38.46 ± 12.9 | 42.23 ± 11.43 | 47.9 ± 11.51 |
Collected over Participant follow-up post enrollment was for 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Triamcinolone 40mg/mL | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Triamcinolone 10mg/mL | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| Soluble Dexamethasone 4mg/mL | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| Age, Continuous(years) | Triamcinolone 40mg/mL | Triamcinolone 10mg/mL | Soluble Dexamethasone 4mg/mL | Total |
|---|---|---|---|---|
| Mean | 64.54 ± 9.99 | 63.77 ± 10.65 | 61.75 ± 9.11 | 63.37 ± 0 |
| Sex: Female, Male(Participants) | Triamcinolone 40mg/mL | Triamcinolone 10mg/mL | Soluble Dexamethasone 4mg/mL | Total |
|---|---|---|---|---|
| Female | 17 | 30 | 22 | 69 |
| Male | 7 | 13 | 6 | 26 |
| Race (NIH/OMB)(Participants) | Triamcinolone 40mg/mL | Triamcinolone 10mg/mL | Soluble Dexamethasone 4mg/mL | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 2 | 1 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 2 | 0 | 2 |
| White | 22 | 40 | 28 | 90 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2019 to primary completion in May 2022, 34 months.
Results were first posted in Jun 2024, 2 years 1 month after primary completion.
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This study is terminated, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Triamcinolone Acetonide · Dexamethasone
University of Missouri-Columbia →