Betamethasone Versus Ketorolac Injection for the Treatment of DeQuervains Tenosynovitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-15

Study Completion Date

2024-10-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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DeQuervain Tendinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Betamethasone

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

Group Type ACTIVE_COMPARATOR

betamethasone

Intervention Type DRUG

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

Ketorolac

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

Group Type EXPERIMENTAL

Ketorolac

Intervention Type DRUG

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

Interventions

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betamethasone

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

Intervention Type DRUG

Ketorolac

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

Intervention Type DRUG

Other Intervention Names

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Celestone Toradol

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No