Betamethasone Versus Ketorolac Injection for the Treatment of DeQuervains Tenosynovitis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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 Design
Arms and Interventions
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
- Grip Strength [pre injection, 2 weeks post injection, 6 weeks post injection]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | OrthoCarolina | Charlotte | North Carolina | United States | 28207 |
Sponsors and Collaborators
- OrthoCarolina Research Institute, Inc.
Investigators
- Principal Investigator: Christopher Chadderdon, MD, OrthoCarolina Research Institute, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15060