Clinical trial NCT02038634
Conditions: DeQuervain's Tenosynovitis
Keywords: wrist tendonitis dequervain's tenosynovitis
Sponsor: Medical College of Wisconsin
Start date: 2014-08-05; Completion date: 2021-03-15
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
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.

Arms: arm 1: Corticosteroid injection (betamethasone) without ultrasound guidance. arm 2: Corticosteroid injections (betamethasone) under ultrasound guidance.
Interventions: intervention 1: Betamethasone intervention 2: Ultrasound
Intervention descriptions: intervention 1: None intervention 2: Ultrasound guided injection using GE Healthcare LOGIQ e Ultrasound

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
 
 
 
 
 
 
Blind vs. Ultrasound-guided Corticosteroid Injections for de Quervain’s disease:   
A Prospective Study 
 
 
 
 
 
NCT02038634 
 
 
 
 
 
February 6, 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Background: 
 
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.5, 6  Conservative treatments include splinting and corticosteroid injections, but surgery is an 
option when such therapy fails.  One study6 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 studies1, 3 and recommends corticosteroid injection to clinicians as a reliable treatment 
for de Quervain’s disease.  
 
A seminal study performed by Zyngas et al.7 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 study4 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 our knowledge, no study has compared the clinical outcomes of blind injections to 
US-guided injections.  We hypothesize that the US-guided injections will result in greater pain 
relief for patients than blind attempts 
 
Study Design: 
 
This is intended to be a prospective study.  Patients will contact the PI for a standard 
clinical evaluation, which includes palpation of the first extensor compartment and application of 
the Finkelstein test.2  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.  The PI 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 accuracy and pain relief for patients than the current standard treatment (blind 
injection).  
 
All Injections will consist of 6 mg betamethasone and 4 cc 1% lidocaine without 
epinephrine, which is standard of care treatment. 
 
In summary, we 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.  
 
 
 


Risk to Subjects: 
A minimal physical risk is temporary inflammation around the wrist which accompanies any 
steroid injection.  There is no risk involved with the addition of ultrasound.  There is a slight risk 
of loss of confidentiality. 
 
Data Analysis: 
The mean DASH scores from the control group (blind injection) and the treatment group (US-
guided injection) will be compared with a t-test to discern any significant statistical difference. 
 
 
Plan for evaluating problems and adverse events (AEs): 
The PI will address any unforeseen problems or events related to the study and the study 
coordinator will report promptly to the IRB. 
 
References: 
1. Anderson BC, Manthey R, Brouns MC. Treatment of de Quervain’s tenosynovitis with 
corticosteroids. A prospective study of the response to local injection. Arthritis Rheum 
1991; 34:793–798. 
2. Elliott BG. Finkelstein’s test: a descriptive error that can produce a false positive. J Hand 
Surg [Br] 1992; 17( 4 ): 481–482. 
3. Harvey FJ, Harvey PM, Horsley MW. De Quervain’s disease: Surgical or nonsurgical 
treatment. J Hand Surg 1990;15A:83–87. 
4. Jeyapalan K , Choudhary S. Ultrasoundguided injection of triamcinolone and bupivacaine 
in the management of De Quervain’s disease. Skeletal Radiol 2009; 38( 11):1099 – 1103. 
5. Piligian G, Herbert R, Hearns M, Dropkin J, Landsbergis P, Cherniack M. Evaluation and 
management of chronic work-related musculoskeletal disorders of the distal upper 
extremity. Am J Ind Med. 2000;37(1):75–93. 
6. Weiss AP, Akelman E, Tabatabai M. Treatment of de Quervain’s disease. J Hand Surg 
1994;19A:595–598. 
7. Zingas C, Failla JM, van Holsbeeck M. Injection accuracy and clinical relief of the 
Quervain’s tendonitis. J Hand Surg 1998;23:89–96.