Ultrasound-guided Injection for DeQuervain's

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Medical College of Wisconsin
Sponsor:
Information provided by (Responsible Party):
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT02038634
First received: September 25, 2013
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
DeQuervain's Tenosynovitis
Drug: Betamethasone
Device: Ultrasound
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ultrasound-guided Injection for DeQuervain's

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Unguided injections
Corticosteroid injection (betamethasone) without ultrasound guidance.
Drug: Betamethasone
Other Name: celestone
Active Comparator: Ultrasound-guided injections
Corticosteroid injections (betamethasone) under ultrasound guidance.
Drug: Betamethasone
Other Name: celestone
Device: Ultrasound
Ultrasound guided injection using GE Healthcare LOGIQ e Ultrasound

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pain with palpation at 1st dorsal compartment at wrist and positive Finkelstein's Test

Exclusion Criteria:

  • Patients with evidence of osteoarthritis or degeneration of the wrist.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02038634

Contacts
Contact: Steven Grindel, MD 414-805-7454 sgrindel@mcw.edu
Contact: Dara Mickschl, PA-C 414-805-7440 dmickschl@mcw.edu

Locations
United States, Wisconsin
Froedtert Hospital Recruiting
Wauwatosa, Wisconsin, United States, 53226
Contact: Grindel    414-805-7454      
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Steven Grindel, MD MCW/Froedtert Hospital
  More Information

No publications provided

Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02038634     History of Changes
Other Study ID Numbers: PRO20646
Study First Received: September 25, 2013
Last Updated: May 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
wrist
tendonitis
dequervain's
tenosynovitis

Additional relevant MeSH terms:
Tenosynovitis
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014