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Betamethasone Versus Ketorolac Injection for the Treatment of DeQuervains Tenosynovitis

Primary Purpose

DeQuervain Tendinopathy

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
betamethasone
Ketorolac
Sponsored by
OrthoCarolina Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for DeQuervain Tendinopathy

Eligibility Criteria

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • OrthoCarolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Betamethasone

Ketorolac

Arm Description

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

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

Outcomes

Primary Outcome Measures

Visual analog scale (VAS) of pain with finklestein test
Visual Analog Scale (VAS) of pain measured on 0 (no pain) - 10 (worst possible pain)

Secondary Outcome Measures

Visual analog scale (VAS) of pain with tenderness over tendon
Visual Analog Scale (VAS) of pain measured on 0 (no pain) - 10 (worst possible pain)
Visual analog scale (VAS) of pain on radial side of wrist
Visual Analog Scale (VAS) of pain measured on 0 (no pain) - 10 (worst possible pain)
The Disabilities of the Arm, Shoulder, and Hand Score (DASH)
Patient-reported evaluation of symptoms as well as ability to perform certain activities. Score is 0-100 (higher scores indicate greater disability). Must answer at least 27/30 questions. Score is 1 to 5 per question. Score is then summed and divided by the number of completed questions. subtract 1 from this number then multiply by 25.
Veterans-Rand 12 (VR-12)
Quality of life using VR-12 subscores. Physical Health (PCS) subscore and Mental Health (MCS) subscore, not summed. Range reported in weighted units. Both PCS/MCS are score 0-100 with 100 indicating the highest level of health.
Pinch Strength
Grip Strength

Full Information

First Posted
November 11, 2015
Last Updated
February 8, 2023
Sponsor
OrthoCarolina Research Institute, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02604537
Brief Title
Betamethasone Versus Ketorolac Injection for the Treatment of DeQuervains Tenosynovitis
Official Title
Betamethason Versus Ketorolac Injection for the Treatment of DeQuervains Tenosynovitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 15, 2015 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OrthoCarolina Research Institute, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
If steroids are effective for Dequervain tenosynovitis because of their anti-inflammatory properties, then there is a reasonable and rational argument to be made for the local injection of NSAIDS (non-steroidal anti-inflammatory drugs) into the first dorsal extensor compartment. Ketorolac is an NSAID that has been proven efficacious in the treatment of another musculoskeletal condition. Moreover, compared to betamethasone (or other injectable corticosteroids), injection of ketorolac decreases the patient exposure to the potential side-effects of corticosteroids, especially that of elevation of blood sugar levels in diabetics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DeQuervain Tendinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Betamethasone
Arm Type
Active Comparator
Arm Description
1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 6 mg/ml betamethasone (Celestone)
Arm Title
Ketorolac
Arm Type
Experimental
Arm Description
1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 30 mg/ml of ketorolac (Toradol)
Intervention Type
Drug
Intervention Name(s)
betamethasone
Other Intervention Name(s)
Celestone
Intervention Description
1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 6 mg/ml betamethasone
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Toradol
Intervention Description
1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 30 mg/ml of ketorolac
Primary Outcome Measure Information:
Title
Visual analog scale (VAS) of pain with finklestein test
Description
Visual Analog Scale (VAS) of pain measured on 0 (no pain) - 10 (worst possible pain)
Time Frame
6 weeks post injection
Secondary Outcome Measure Information:
Title
Visual analog scale (VAS) of pain with tenderness over tendon
Description
Visual Analog Scale (VAS) of pain measured on 0 (no pain) - 10 (worst possible pain)
Time Frame
pre injection, 2 weeks post injection, 6 weeks post injection
Title
Visual analog scale (VAS) of pain on radial side of wrist
Description
Visual Analog Scale (VAS) of pain measured on 0 (no pain) - 10 (worst possible pain)
Time Frame
pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 month post injection
Title
The Disabilities of the Arm, Shoulder, and Hand Score (DASH)
Description
Patient-reported evaluation of symptoms as well as ability to perform certain activities. Score is 0-100 (higher scores indicate greater disability). Must answer at least 27/30 questions. Score is 1 to 5 per question. Score is then summed and divided by the number of completed questions. subtract 1 from this number then multiply by 25.
Time Frame
pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 months post injection
Title
Veterans-Rand 12 (VR-12)
Description
Quality of life using VR-12 subscores. Physical Health (PCS) subscore and Mental Health (MCS) subscore, not summed. Range reported in weighted units. Both PCS/MCS are score 0-100 with 100 indicating the highest level of health.
Time Frame
pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 months post injection
Title
Pinch Strength
Time Frame
pre-injection, 2 weeks post injection, 6 weeks post injection
Title
Grip Strength
Time Frame
pre injection, 2 weeks post injection, 6 weeks post injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Chadderdon, MD
Organizational Affiliation
OrthoCarolina Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
OrthoCarolina
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States

12. IPD Sharing Statement

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Betamethasone Versus Ketorolac Injection for the Treatment of DeQuervains Tenosynovitis

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