Betamethasone Versus Ketorolac Injection for the Treatment of DeQuervains Tenosynovitis

Betamethason Versus Ketorolac Injection for the Treatment of DeQuervains Tenosynovitis

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

Study Overview

• Status: Active, not recruiting
• Conditions: DeQuervain Tendinopathy
• Intervention / Treatment: Drug: betamethasone; Drug: Ketorolac

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 Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Betamethasone; 1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 6 mg/ml betamethasone (Celestone)	Drug: betamethasone; 1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 6 mg/ml betamethasone; Other Names: Celestone
Experimental: Ketorolac; 1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 30 mg/ml of ketorolac (Toradol)	Drug: Ketorolac; 1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 30 mg/ml of ketorolac; Other Names: Toradol

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	pre injection, 2 weeks post injection, 6 weeks post injection
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)	pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 month post injection
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.	pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 months post injection
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.	pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 months post injection
Pinch Strength		pre-injection, 2 weeks post injection, 6 weeks post injection
Grip Strength		pre injection, 2 weeks post injection, 6 weeks post injection

Collaborators and Investigators

• Sponsor: OrthoCarolina Research Institute, Inc.
• Investigators: Principal Investigator: Christopher Chadderdon, MD, OrthoCarolina Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2015
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 11, 2015
• First Submitted That Met QC Criteria: November 11, 2015
• First Posted (Estimated): November 13, 2015

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Tenosynovitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Ketorolac; Betamethasone
• Other Study ID Numbers: 15060

Drug and device information, study documents

• 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