NCT02604537

Brief Summary

The purpose of this study is to determine if corticosteroid injection modifies the natural course of de Quervain tendinopathy compared to a toradol injection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

9 years

First QC Date

November 11, 2015

Last Update Submit

March 31, 2026

Conditions

DeQuervain Tendinopathy

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale (VAS) of pain with finklestein test

    Visual Analog Scale (VAS) of pain measured on 0 (no pain) - 10 (worst possible pain)

    6 weeks post injection

Secondary Outcomes (6)

  • Visual analog scale (VAS) of pain with tenderness over tendon

    pre injection, 2 weeks post injection, 6 weeks post injection

  • Visual analog scale (VAS) of pain on radial side of wrist

    pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 month post injection

  • The Disabilities of the Arm, Shoulder, and Hand Score (DASH)

    pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 months post injection

  • Veterans-Rand 12 (VR-12)

    pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 months post injection

  • Pinch Strength

    pre-injection, 2 weeks post injection, 6 weeks post injection

  • +1 more secondary outcomes

Study Arms (2)

Betamethasone

ACTIVE COMPARATOR

1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 6 mg/ml betamethasone (Celestone)

Drug: betamethasone

Ketorolac

EXPERIMENTAL

1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 30 mg/ml of ketorolac (Toradol)

Drug: Ketorolac

Interventions

betamethasoneDRUG

1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 6 mg/ml betamethasone

Also known as: Celestone
Betamethasone
KetorolacDRUG

1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 30 mg/ml of ketorolac

Also known as: Toradol
Ketorolac

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of DeQuervain tendinopathy
  • Understands the local language and is willing and able to follow the requirements of the protocol
  • Understands the informed consent and signs the institutional review board/independent ethics committee (IRB/IEC) approved informed consent form

You may not qualify if:

  • Patients who have an allergy to lidocaine, celestone, or ketorolac, nonsteroidal anti-inflammatory drugs (NSAIDs), or acetylsalicylic acid (ASA)
  • Patients who have an adverse reaction to lidocaine, celestone, or ketorolac (such as severe elevation of blood sugars in diabetics that caused medical complication)
  • Patients who have received a prior steroid injection within the past three months
  • Patients who have had a prior ipsilateral surgery for DeQuervain Tenosynovitis
  • Patients that have a skin lesion at the location of injection (such as trauma, eczema, rash)
  • Patients who have a current infection at the location of injection
  • Patients who have had iontophoresis within three months
  • Patients who are breast feeding, pregnant, or who plan to become pregnant in the next six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OrthoCarolina

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Interventions

BetamethasoneKetorolacKetorolac Tromethamine

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedIndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Christopher Chadderdon, MD

    OrthoCarolina Research Institute, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2015

First Posted

November 13, 2015

Study Start

October 15, 2015

Primary Completion

October 1, 2024

Study Completion

October 30, 2024

Last Updated

April 1, 2026

Record last verified: 2026-03

Locations

US(1)