Ultrasound-guided Injection for DeQuervain's

NCT ID: NCT02038634

Last Updated: 2022-12-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-05
• Study Completion Date: 2021-03-15

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.

Conditions

DeQuervain's Tenosynovitis

Keywords

wrist; tendonitis; dequervain's; tenosynovitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Unguided injections

Corticosteroid injection (betamethasone) without ultrasound guidance.

Group Type: ACTIVE_COMPARATOR

Betamethasone

Intervention Type: DRUG

Ultrasound-guided injections

Corticosteroid injections (betamethasone) under ultrasound guidance.

Group Type: ACTIVE_COMPARATOR

Betamethasone

Intervention Type: DRUG

Ultrasound

Intervention Type: DEVICE

Ultrasound guided injection using GE Healthcare LOGIQ e Ultrasound

Interventions

Betamethasone

Intervention Type: DRUG

Ultrasound

Ultrasound guided injection using GE Healthcare LOGIQ e Ultrasound

Intervention Type: DEVICE

Other Intervention Names

celestone

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Steven Grindel

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven Grindel, MD

Role: PRINCIPAL_INVESTIGATOR

MCW/Froedtert Hospital

Locations

Froedtert Hospital

Wauwatosa, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PRO20646

Identifier Type: -

Identifier Source: org_study_id