DeQuervain Tendinopathy Clinical Trial
Official title:
Betamethason Versus Ketorolac Injection for the Treatment of DeQuervains Tenosynovitis
| Verified date | April 2024 |
| Source | OrthoCarolina Research Institute, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine if corticosteroid injection modifies the natural course of de Quervain tendinopathy compared to a toradol injection.
| Status | Active, not recruiting |
| Enrollment | 64 |
| Est. completion date | December 31, 2025 |
| Est. primary completion date | December 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | OrthoCarolina | Charlotte | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| OrthoCarolina Research Institute, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Pinch Strength | pre-injection, 2 weeks post injection, 6 weeks post injection | ||
| Secondary | Grip Strength | pre injection, 2 weeks post injection, 6 weeks post injection |