Trigger FingerPhase 4NCT04002037
Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis
A Phase 4 study testing Triamcinolone Acetonide 40mg/mL, Triamcinolone Acetonide 10mg/mL and Dexamethasone 4 mg/ml in people with Trigger Finger, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
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. 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?
- Triamcinolone Acetonide 40mg/mL, Triamcinolone Acetonide 10mg/mL and Dexamethasone 4 mg/ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2019to 1 Jan 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
- Adults aged 18 years and older
- At least one symptomatic trigger finger
- Patients recommended to receive corticosteroid injections
Who cannot join
- Previous surgeries/injections for trigger fingers in digit being treated for study
- Participating in another clinical trial
- Inability to receive corticosteroid injections (i.e. allergies, adverse reactions, etc.)
- Unable to sign informed consent
- Pregnant or plan to become pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri Health Care
Columbia, Missouri, 65212
About this study
Official title: Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis: A Double-Blind Prospective Randomized Clinical Trial
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).
Read the detailed description
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:
- Injection of corticosteroid into the area immediately surrounding the A1 pulley and flexor tendon
- Surgical release of the A1 pulley
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:
- Adults aged 18 years and older
- At least one symptomatic trigger finger
- Patients recommended to receive corticosteroid injections
Exclusion criteria:
- Previous surgeries/injections for trigger fingers in digit being treated for study
- Participating in another clinical trial
- Inability to receive corticosteroid injections (i.e. allergies, adverse reactions, etc.)
- Unable to sign informed consent
- Pregnant or plan to become pregnant
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:
- Triamcinolone 40mg/mL
- Triamcinolone 10mg/mL
- Soluble dexamethasone 4mg/mL
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:
- Grade of triggering (Green classification of trigger finger severity1)
Subjective Measures:
- QuickDASH
- PROMIS scores
- VAS Second Corticosteroid injection (if subject still symptomatic) 12 Week (3 Month) Follow-Up (if applicable):
Objective Measures:
- Grade of triggering (Green classification of trigger finger severity1)
Subjective Measures:
- QuickDASH
- PROMIS scores
- VAS
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.
- Conditions
- Trigger Finger
- Being tested
- Triamcinolone Acetonide 40mg/mL, Triamcinolone Acetonide 10mg/mL, Dexamethasone 4 mg/ml
- Keywords
- Trigger Finger
- 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.
Triamcinolone Acetonide 40mg/mLDrug
Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
Triamcinolone Acetonide 10mg/mLDrug
Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
Dexamethasone 4 mg/mlDrug
Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
| Study group | Role | What they receive |
|---|---|---|
| Triamcinolone 40mg/mL | Active comparator | A corticosteroid injection of Triamcinolone 40mg/mL will be given to subjects to treat their symptoms of trigger finger. Receives: Drug: Triamcinolone Acetonide 40mg/mL |
| Triamcinolone 10mg/mL | Active comparator | A corticosteroid injection of Triamcinolone 10mg/mL will be given to subjects to treat their symptoms of trigger finger. Receives: Drug: Triamcinolone Acetonide 10mg/mL |
| Soluble dexamethasone 4mg/mL | Active comparator | A corticosteroid injection of Soluble Dexamethasone 4mg/mL will be given to subjects to treat their symptoms of trigger finger. Receives: Drug: Dexamethasone 4 mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start25 Jun 2019
- Primary completion19 May 2022
- Study completion1 Jan 2023
Why it stopped: Preliminary analysis revealed no difference
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 (1)Papers the sponsor has linked to this study.
- Other trials for Trigger FingerStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel London, University of Missouri-Columbia
- Investigators
- Daniel London, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002037
- Sponsor's protocol ID
- 2014039
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2019
- Last updated
- 26 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
1- Wolfe SW, Hotchkiss RN, Pederson WC, Kozin SH, Tendinopathy, in: Green's Operative Hand Surgery, 6th edition, Churchill Livingstone, Chap. 62, p. 5, 2011.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis: A Double-Blind Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04002037
- Acronym / sponsor ID
- 2014039
- Conditions
- Trigger Finger
- Keywords
- Trigger Finger
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Preliminary analysis revealed no difference
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 19 May 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Posted 26 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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:
- Injection of corticosteroid into the area immediately surrounding the A1 pulley and flexor tendon
- Surgical release of the A1 pulley
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:
- Adults aged 18 years and older
- At least one symptomatic trigger finger
- Patients recommended to receive corticosteroid injections
Exclusion criteria:
- Previous surgeries/injections for trigger fingers in digit being treated for study
- Participating in another clinical trial
- Inability to receive corticosteroid injections (i.e. allergies, adverse reactions, etc.)
- Unable to sign informed consent
- Pregnant or plan to become pregnant
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:
- Triamcinolone 40mg/mL
- Triamcinolone 10mg/mL
- Soluble dexamethasone 4mg/mL
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:
- Grade of triggering (Green classification of trigger finger severity1)
Subjective Measures:
- QuickDASH
- PROMIS scores
- VAS Second Corticosteroid injection (if subject still symptomatic) 12 Week (3 Month) Follow-Up (if applicable):
Objective Measures:
- Grade of triggering (Green classification of trigger finger severity1)
Subjective Measures:
- QuickDASH
- PROMIS scores
- VAS
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Triamcinolone 40mg/mL | Active comparator | Drug: Triamcinolone Acetonide 40mg/mLA corticosteroid injection of Triamcinolone 40mg/mL will be given to subjects to treat their symptoms of trigger finger. |
| Triamcinolone 10mg/mL | Active comparator | Drug: Triamcinolone Acetonide 10mg/mLA corticosteroid injection of Triamcinolone 10mg/mL will be given to subjects to treat their symptoms of trigger finger. |
| Soluble dexamethasone 4mg/mL | Active comparator | Drug: Dexamethasone 4 mg/mlA corticosteroid injection of Soluble Dexamethasone 4mg/mL will be given to subjects to treat their symptoms of trigger finger. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years and older
- At least one symptomatic trigger finger
- Patients recommended to receive corticosteroid injections
Key exclusion criteria (5 listed)
- Previous surgeries/injections for trigger fingers in digit being treated for study
- Participating in another clinical trial
- Inability to receive corticosteroid injections (i.e. allergies, adverse reactions, etc.)
- Unable to sign informed consent
- Pregnant or plan to become pregnant
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 Acetonide 40mg/mLCorticosteroid injection will occur up to two times if trigger finger symptoms are not resolved. | Drug | Triamcinolone 40mg/mL |
| Triamcinolone Acetonide 10mg/mLCorticosteroid injection will occur up to two times if trigger finger symptoms are not resolved. | Drug | Triamcinolone 10mg/mL |
| Dexamethasone 4 mg/mlCorticosteroid injection will occur up to two times if trigger finger symptoms are not resolved. | Drug | Soluble dexamethasone 4mg/mL |
Primary outcome
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: 6 Weeks
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.
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: 12 Weeks
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.
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: 6 Month
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.
Pain Visual Analog Score (VAS)
Time frame: 6 Weeks
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.
Pain Visual Analog Score (VAS)
Time frame: 12 Weeks
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.
Pain Visual Analog Score (VAS)
Time frame: 6 Month
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.
Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores
Time frame: 6 Weeks
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.
Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores
Time frame: 12 Weeks
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.
Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores
Time frame: 6 Month
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background1- Wolfe SW, Hotchkiss RN, Pederson WC, Kozin SH, Tendinopathy, in: Green's Operative Hand Surgery, 6th edition, Churchill Livingstone, Chap. 62, p. 5, 2011.
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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.
Daniel London, MD principal investigator
University of Missouri-Columbia
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 Acetonide 40mg/mL, Triamcinolone Acetonide 10mg/mL and Dexamethasone 4 mg/ml in people with Trigger Finger, run by University of Missouri-Columbia 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 3 inclusion and 5 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 26 Jun 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 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 26 Jun 2024). 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?
Disabilities of the Arm, Shoulder and Hand (DASH) (time frame: 6 Weeks). The study lists 9 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 NCT04002037, which also lists 1 linked publication.
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 26 Jun 2024.