Betamethasone Versus Ketorolac Injection for the Treatment of DeQuervains Tenosynovitis

Phase 4

Completed

• Conditions: DeQuervain Tendinopathy
• Interventions: Drug: betamethasone; Drug: Ketorolac

• Registration Number: NCT02604537
• Lead Sponsor: OrthoCarolina Research Institute, Inc.

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.

Study Timeline

• Study Start: 2015-10-15
• Study First Submitted: 2015-11-11
• Study First Submitted QC: 2015-11-11
• Study First Posted: 2015-11-13
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Betamethasone	betamethasone	1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 6 mg/ml betamethasone (Celestone)
Ketorolac	Ketorolac	1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 30 mg/ml of ketorolac (Toradol)

Primary Outcome Measures

Name	Time	Method
Visual analog scale (VAS) of pain with finklestein test	6 weeks post injection	Visual Analog Scale (VAS) of pain measured on 0 (no pain) - 10 (worst possible pain)

Secondary Outcome Measures

Name	Time	Method
Grip Strength	pre injection, 2 weeks post injection, 6 weeks post injection
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 measured on 0 (no pain) - 10 (worst possible pain)
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	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)	pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 months post injection	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)	pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 months post injection	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	pre-injection, 2 weeks post injection, 6 weeks post injection

Trial Locations

Locations (1)

OrthoCarolina; 🇺🇸 Charlotte, North Carolina, United States