A Phase 4 interventional study of Betamethasone and Ultrasound in DeQuervain's Tenosynovitis, sponsored by Medical College of Wisconsin. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-28.
Sponsored by Medical College of Wisconsin · Phase 4, Interventional, and Treatment
The investigators aim to perform a prospective study to evaluate the effectiveness of blind corticosteroid injections to US-guided injections for the treatment of de Quervain's disease. The results of the study will be used to validate current injection protocols or support the incorporation of ultrasonography to treat the disease.
De Quervain's disease is the stenosing tenosynovitis and tendinitis of the abductor pollicis longus (APL) and extensor pollicis brevis (EPB) tendons in the first dorsal compartment of the wrist. While the prevalence of de Quervain's is not yet well-established, previous studies have shown that women can be affected by the disease up to six times more frequently than men. Conservative treatments include splinting and corticosteroid injections, but surgery is an option when such therapy fails. There has been a previous study that compared the improvement rates of patients treated with splinting alone, injection and splinting, and injection alone, and found the rate of improvement to be 19%, 57%, 67%, respectively. This confirmed the good results reported in previous studies and recommends corticosteroid injection to clinicians as a reliable treatment for de Quervain's disease.
A seminal study performed correlated the accuracy of corticosteroid injection with pain relief by including X-ray dye in the injection. The results of the study suggested a strong correlation between accurate injection of the first dorsal compartment and pain relief. Since then, the use of ultrasonography (US) to guide steroid injection has been suggested as a possible clinical practice, but little research has been done on the technique. A 2009 study reported a 93.75% rate of significant pain relief after the use of US-guided injections, but there was no control group with which to compare results. The current standard practice for steroid injection in de Quervain's patients is a blind injection without imaging guidance. To the investigators knowledge, no study has compared the accuracy and clinical outcomes of blind injections to US-guided injections. The investigators hypothesize that the US-guided injections will be and will result in greater pain relief for patients than blind injections.
This is intended to be a prospective study. Patients will contact Dr.'s Grindel and Daley for a standard clinical evaluation, which includes palpation of the first extensor compartment and application of the Finkelstein test. Those diagnosed with de Quervain's disease and who fit all inclusion criteria will receive a detailed verbal description of the study from one of the doctors, who will then attain written, informed consent from willing participants. Dr.'s Grindel or Daley will then administer either a blind or US-guided injection. The patient will return for follow-up appointments at 6-8 weeks and 12-16 weeks and will undergo another physical exam to determine pain relief. A phone call follow-up will also be placed one year after the injection in order to determine long-term effectiveness. Once 20 study subjects in each group (40 total) have been enrolled and completed treatment, the data will undergo statistical analysis.
This study poses minimal or no physical risk to study subjects, as the US-guided injection should show better pain relief for patients than the current standard treatment (blind injection).
In summary, the investigators aim to perform a prospective study to evaluate the effectiveness of blind corticosteroid injections to US-guided injections for the treatment of de Quervain's disease. The results of the study will be used to validate current injection protocols or support the incorporation of ultrasonography to treat the disease.
17 studies on the registry are indexed under Tenosynovitis; 4 are open to participants now.
This study's enrollment of 16 is below the median of 52 across 13 interventional studies indexed under Tenosynovitis.
Browse Tenosynovitis studies →Medical College of Wisconsin is the lead sponsor of 548 studies on the registry; 122 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 57 (76%) have results posted.
Compared within Tenosynovitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Tendinopathy. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Corticosteroid injection (betamethasone) without ultrasound guidance.
Drug: Betamethasone
Corticosteroid injections (betamethasone) under ultrasound guidance.
Drug: Betamethasone · Device: Ultrasound
Also known as: celestone
Ultrasound guided injection using GE Healthcare LOGIQ e Ultrasound
DASH - "Disabilities of the Arm, Shoulder, and Hand" Score At Baseline, and Change From Baseline at 6-8 Weeks, 12-16 Weeks, and at 1 Year
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire. Questions 1-30, the scale is a 1-5 scale (1=no difficulty; 2=mild difficulty; 3=moderate difficulty; 4=severe difficulty; 5=unable) DASH Disability/Symptom Score = \[(sum of n responses)/n) -1\] x 25. A lower score is a better outcome. The Dash is based on a scale of 0-100. Our scores were averaged and the Mean scores are what we reported. Total scores are listed below. US Guided Group - Dash #1 (Min=25, Mean=58, Max=90) n=12; Dash #2 (Min=3, Mean=38, Max=91) n=12; Dash #3 (Min=6, Mean=42, Max=71) n=10; 1 Year Dash (Min=0, Mean =29, Max=91) n=12. Non-US Guided Group - Dash #1 (Min=23, Mean=39, Max=61) n=3; Dash #2 (Min=0, Mean=11, Max=22) n=3; Dash #3 (Min=7, Mean=30, Max=49) n=3; 1 Year Dash (Min=0, Mean=9, Max=25) n=3.
Time frame: Prior to injection (Dash #1), 6-8 weeks (Dash #2), 12-16 weeks (Dash #3), and 1 year (Dash #4) post-injection
Participants were recruited based by the PI between August 2013 and April 2021. The first participant was enrolled on August 5, 2014 and the last participant was enrolled on December 9, 2018
| Milestone | Unguided Injections | Ultrasound-guided Injections |
|---|---|---|
| Started | 3 | 13 |
| Completed | 3 | 12 |
| Not completed | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire. Questions 1-30, the scale is a 1-5 scale (1=no difficulty; 2=mild difficulty; 3=moderate difficulty; 4=severe difficulty; 5=unable) DASH Disability/Symptom Score = \[(sum of n responses)/n) -1\] x 25. A lower score is a better outcome. The Dash is based on a scale of 0-100. Our scores were averaged and the Mean scores are what we reported. Total scores are listed below. US Guided Group - Dash #1 (Min=25, Mean=58, Max=90) n=12; Dash #2 (Min=3, Mean=38, Max=91) n=12; Dash #3 (Min=6, Mean=42, Max=71) n=10; 1 Year Dash (Min=0, Mean =29, Max=91) n=12. Non-US Guided Group - Dash #1 (Min=23, Mean=39, Max=61) n=3; Dash #2 (Min=0, Mean=11, Max=22) n=3; Dash #3 (Min=7, Mean=30, Max=49) n=3; 1 Year Dash (Min=0, Mean=9, Max=25) n=3.
| score on a scale | Unguided Injections | Ultrasound-guided Injections |
|---|---|---|
| Dash #1 Pre-Injection | 39 (23 to 61) | 58 (25 to 90) |
| Dash #2 6-8 Weeks | 11 (0 to 22) | 38 (3 to 91) |
| Dash #3 12-16 Weeks | 30 (7 to 49) | 42 (6 to 71) |
| Dash #4 - 1 Year | 9 (0 to 25) | 29 (0 to 91) |
Collected over Adverse event data was collected over 1 year.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Unguided Injections | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Ultrasound-guided Injections | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Age, Categorical(Participants) | Unguided Injections | Ultrasound-guided Injections | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 11 | 13 |
| >=65 years | 1 | 2 | 3 |
| Sex: Female, Male(Participants) | Unguided Injections | Ultrasound-guided Injections | Total |
|---|---|---|---|
| Female | 2 | 13 | 15 |
| Male | 1 | 0 | 1 |
| Race and Ethnicity Not Collected(Participants) | Unguided Injections | Ultrasound-guided Injections | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — We have no plan to share the data we have collected with any other researchers.
Ran from Aug 2014 to primary completion in Mar 2021, 79 months.
Results were first posted in Dec 2022, 1 year 9 months after primary completion.
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