Clinical trial NCT02604537: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: DeQuervain Tendinopathy
Lead sponsor: OrthoCarolina Research Institute, Inc.
Sponsor class: OTHER
First posted: 2015-11-13
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual analog scale (VAS) of pain with finklestein test
timeFrame: 6 weeks post injection
Secondary outcomes:
measure: Visual analog scale (VAS) of pain with tenderness over tendon
timeFrame: pre injection, 2 weeks post injection, 6 weeks post injection
measure: Visual analog scale (VAS) of pain on radial side of wrist
timeFrame: pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 month post injection
measure: The Disabilities of the Arm, Shoulder, and Hand Score (DASH)
timeFrame: pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 months post injection
measure: Veterans-Rand 12 (VR-12)
timeFrame: pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 months post injection
measure: Pinch Strength
timeFrame: pre-injection, 2 weeks post injection, 6 weeks post injection
measure: Grip Strength
timeFrame: pre injection, 2 weeks post injection, 6 weeks post injection
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina
state: North Carolina
Study officials:
affiliation: OrthoCarolina Research Institute, Inc.
name: Christopher Chadderdon, MD
role: PRINCIPAL_INVESTIGATOR
References: