Ultrasound-guided Injection for DeQuervain's

NCT02038634 | Terminated Phase 4 Results DMC

• 1 other identifier: PRO20646
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

DeQuervain's Tenosynovitis

Keywords

wrist; tendonitis; dequervain's; tenosynovitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Prior to injection (Dash #1), 6-8 weeks (Dash #2), 12-16 weeks (Dash #3), and 1 year (Dash #4) post-injection

Study Arms (2)

Unguided injections

ACTIVE COMPARATOR

Corticosteroid injection (betamethasone) without ultrasound guidance.

Drug: Betamethasone

Ultrasound-guided injections

ACTIVE COMPARATOR

Corticosteroid injections (betamethasone) under ultrasound guidance.

Drug: Betamethasone; Device: Ultrasound

Interventions

Betamethasone DRUG

Also known as: celestone

Ultrasound-guided injections; Unguided injections

Ultrasound DEVICE

Ultrasound guided injection using GE Healthcare LOGIQ e Ultrasound

Ultrasound-guided injections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with evidence of osteoarthritis or degeneration of the wrist.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital

Wauwatosa, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Tendinopathy; Tenosynovitis

Interventions

Betamethasone; Ultrasonography

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Limitations and Caveats

Early termination due to lack of subject participation; statistical analysis not done due to small numbers. Outcome Measure # 2 was originally posted but was deleted as it was not included as part of the study design. No data was collected for that proposed outcome.

Results Point of Contact

• Title: Karen Gonzalez
• Organization: Medical College of Wisconsin

kgonzalez@mcw.edu

414-955-3221

Study Officials

• Steven Grindel, MD

  MCW/Froedtert Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 25, 2013
• First Posted: January 16, 2014
• Study Start: August 5, 2014
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: December 28, 2022
• Results First Posted: December 28, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)