Ultrasound-guided Injection for DeQuervain's
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|ClinicalTrials.gov Identifier: NCT02038634|
Recruitment Status : Recruiting
First Posted : January 16, 2014
Last Update Posted : February 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|DeQuervain's Tenosynovitis||Drug: Betamethasone Device: Ultrasound||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ultrasound-guided Injection for DeQuervain's|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2020|
Active Comparator: Unguided injections
Corticosteroid injection (betamethasone) without ultrasound guidance.
Other Name: celestone
Active Comparator: Ultrasound-guided injections
Corticosteroid injections (betamethasone) under ultrasound guidance.
Other Name: celestoneDevice: Ultrasound
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 [ Time Frame: Prior to injection, 6-8 weeks and 12-16 weeks post injection ]Disabilities of the Arm, Shoulder, and Hand
- Pain Scores on the Visual Analogue Scale (VAS) [ Time Frame: Assessed prior to injection, at 6-8 weeks post, and 12-16 weeks post injection ]Visual Analogue Scale
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): NCT02038634
|Contact: Steven Grindel, MDfirstname.lastname@example.org|
|Contact: Dara Mickschl, PA-Cemail@example.com|
|United States, Wisconsin|
|Wauwatosa, Wisconsin, United States, 53226|
|Contact: Grindel 414-955-3222|
|Principal Investigator:||Steven Grindel, MD||MCW/Froedtert Hospital|