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Betamethasone Versus Ketorolac Injection for the Treatment of DeQuervains Tenosynovitis

O

OrthoCarolina Research Institute, Inc.

Status and phase

Completed
Phase 4

Conditions

DeQuervain Tendinopathy

Treatments

Drug: Ketorolac
Drug: betamethasone

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

64 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

64 participants in 2 patient groups

Betamethasone
Active Comparator group
Description:
1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 6 mg/ml betamethasone (Celestone)
Treatment:
Drug: betamethasone
Ketorolac
Experimental group
Description:
1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 30 mg/ml of ketorolac (Toradol)
Treatment:
Drug: Ketorolac

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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