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Ultrasound-guided Injection for DeQuervain's

Primary Purpose

DeQuervain's Tenosynovitis

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Betamethasone
Ultrasound
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for DeQuervain's Tenosynovitis focused on measuring wrist, tendonitis, dequervain's, tenosynovitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Froedtert Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Unguided injections

Ultrasound-guided injections

Arm Description

Corticosteroid injection (betamethasone) without ultrasound guidance.

Corticosteroid injections (betamethasone) under ultrasound guidance.

Outcomes

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, 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.

Secondary Outcome Measures

Full Information

First Posted
September 25, 2013
Last Updated
November 23, 2022
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT02038634
Brief Title
Ultrasound-guided Injection for DeQuervain's
Official Title
Ultrasound-guided Injection for DeQuervain's
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
not enough patient data
Study Start Date
August 5, 2014 (Actual)
Primary Completion Date
March 15, 2021 (Actual)
Study Completion Date
March 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DeQuervain's Tenosynovitis
Keywords
wrist, tendonitis, dequervain's, tenosynovitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unguided injections
Arm Type
Active Comparator
Arm Description
Corticosteroid injection (betamethasone) without ultrasound guidance.
Arm Title
Ultrasound-guided injections
Arm Type
Active Comparator
Arm Description
Corticosteroid injections (betamethasone) under ultrasound guidance.
Intervention Type
Drug
Intervention Name(s)
Betamethasone
Other Intervention Name(s)
celestone
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
Ultrasound guided injection using GE Healthcare LOGIQ e Ultrasound
Primary Outcome Measure Information:
Title
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
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Grindel, MD
Organizational Affiliation
MCW/Froedtert Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Froedtert Hospital
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We have no plan to share the data we have collected with any other researchers.

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Ultrasound-guided Injection for DeQuervain's

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