Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis
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ClinicalTrials.gov Identifier: NCT04002037 |
Recruitment Status :
Terminated
(Preliminary analysis revealed no difference)
First Posted : June 28, 2019
Last Update Posted : October 5, 2023
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Condition or disease | Intervention/treatment | Phase |
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Trigger Finger | Drug: Triamcinolone Acetonide 40mg/mL Drug: Triamcinolone Acetonide 10mg/mL Drug: Dexamethasone 4 mg/ml | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis: A Double-Blind Prospective Randomized Clinical Trial |
Actual Study Start Date : | June 25, 2019 |
Actual Primary Completion Date : | May 19, 2022 |
Actual Study Completion Date : | January 1, 2023 |
Arm | Intervention/treatment |
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Active Comparator: Triamcinolone 40mg/mL
A corticosteroid injection of Triamcinolone 40mg/mL will be given to subjects to treat their symptoms of trigger finger.
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Drug: Triamcinolone Acetonide 40mg/mL
Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved. |
Active Comparator: Triamcinolone 10mg/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
Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved. |
Active Comparator: Soluble dexamethasone 4mg/mL
A corticosteroid injection of Soluble Dexamethasone 4mg/mL will be given to subjects to treat their symptoms of trigger finger.
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Drug: Dexamethasone 4 mg/ml
Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved. |
- Green classification of trigger finger severity [ Time Frame: 6 Weeks ]The degree of triggering will be determined by the investigator and recorded. The grade of triggering will be scored on a grading scale of 1, 2, 3 or 4. Grade 1 is palm pain and tenderness at A-1 pulley, Grade 2 is catching of digit, and Grade 3 is locking of digit, passively correctable, and Grade 4 is classified as a fixed or locked digit.
- Green classification of trigger finger severity [ Time Frame: 6 Month ]The degree of triggering will be determined by the investigator and recorded. The grade of triggering will be scored on a grading scale of 1, 2, 3 or 4. Grade 1 is palm pain and tenderness at A-1 pulley, Grade 2 is catching of digit, and Grade 3 is locking of digit, passively correctable, and Grade 4 is classified as a fixed or locked digit.
- Green classification of trigger finger severity [ Time Frame: 12 Weeks ]The degree of triggering will be determined by the investigator and recorded. The grade of triggering will be scored on a grading scale of 1, 2, 3 or 4. Grade 1 is palm pain and tenderness at A-1 pulley, Grade 2 is catching of digit, and Grade 3 is locking of digit, passively correctable, and Grade 4 is classified as a fixed or locked digit.
- 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.
- Upper Extremity Scores (PROMIS) [ Time Frame: 6 Weeks ]The patient will be asked to complete a questionnaire with questions related to their hand.
- Upper Extremity Scores (PROMIS) [ Time Frame: 12 Weeks ]The patient will be asked to complete a questionnaire with questions related to their hand.
- Upper Extremity Scores (PROMIS) [ Time Frame: 6 Month ]The patient will be asked to complete a questionnaire with questions related to their hand.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002037
United States, Missouri | |
University of Missouri Health Care | |
Columbia, Missouri, United States, 65212 |
Principal Investigator: | Jay Bridgeman, MD | University of Missouri-Columbia |
Responsible Party: | Daniel London, Assistant Professor, Orthopaedic Surgery, University of Missouri-Columbia |
ClinicalTrials.gov Identifier: | NCT04002037 |
Other Study ID Numbers: |
2014039 |
First Posted: | June 28, 2019 Key Record Dates |
Last Update Posted: | October 5, 2023 |
Last Verified: | October 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Trigger Finger |
Trigger Finger Disorder Tenosynovitis Tendon Entrapment Tendinopathy Muscular Diseases Musculoskeletal Diseases Dexamethasone Triamcinolone Triamcinolone Acetonide Triamcinolone hexacetonide Triamcinolone diacetate Anti-Inflammatory Agents Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |