DeQuervain TendinopathyPhase 4NCT02604537
Betamethasone Versus Ketorolac Injection for the Treatment of DeQuervains Tenosynovitis
A Phase 4 study testing betamethasone and Ketorolac in people with DeQuervain Tendinopathy, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DeQuervain Tendinopathy
- What is being tested?
- betamethasone and Ketorolac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2015to 30 Oct 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- DeQuervain Tendinopathy
- Being tested
- betamethasone, Ketorolac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
betamethasoneDrug
Also called Celestone
1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 6 mg/ml betamethasone
KetorolacDrug
Also called Toradol
1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 30 mg/ml of ketorolac
| Study group | Role | What they receive |
|---|---|---|
| Betamethasone | Active comparator | 1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 6 mg/ml betamethasone (Celestone) Receives: Drug: betamethasone |
| Ketorolac | Experimental | 1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 30 mg/ml of ketorolac (Toradol) Receives: Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS) of pain with finklestein test
Visual Analog Scale (VAS) of pain measured on 0 (no pain) - 10 (worst possible pain)
Measured: 6 weeks post injection
Secondary outcomes (6)
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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 months post injection
Pinch Strength
Measured: pre-injection, 2 weeks post injection, 6 weeks post injection
Grip Strength
Measured: pre injection, 2 weeks post injection, 6 weeks post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study start15 Oct 2015
- Primary completion1 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeQuervain TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Chadderdon, MD, Principal investigator, OrthoCarolina Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604537
- Sponsor's protocol ID
- 15060
- Status last verified
- Mar 2026
- First submitted
- 11 Nov 2015
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Betamethason Versus Ketorolac Injection for the Treatment of DeQuervains Tenosynovitis
- ClinicalTrials.gov ID
- NCT02604537
- Acronym / sponsor ID
- 15060
- Conditions
- DeQuervain Tendinopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Study start
- 15 Oct 2015 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Betamethasone | Active comparator | Drug: betamethasone1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 6 mg/ml betamethasone (Celestone) |
| Ketorolac | Experimental | Drug: Ketorolac1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 30 mg/ml of ketorolac (Toradol) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| betamethasoneAlso: Celestone1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 6 mg/ml betamethasone | Drug | Betamethasone |
| KetorolacAlso: Toradol1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 30 mg/ml of ketorolac | Drug | Ketorolac |
Primary outcome
Visual analog scale (VAS) of pain with finklestein test
Time frame: 6 weeks post injection
Visual Analog Scale (VAS) of pain measured on 0 (no pain) - 10 (worst possible pain)
6 secondary outcomes
Visual analog scale (VAS) of pain with tenderness over tendon
Time frame: pre injection, 2 weeks post injection, 6 weeks post injection
Visual analog scale (VAS) of pain on radial side of wrist
Time frame: 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)
Time frame: pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 months post injection
Veterans-Rand 12 (VR-12)
Time frame: pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 months post injection
Pinch Strength
Time frame: pre-injection, 2 weeks post injection, 6 weeks post injection
Grip Strength
Time frame: pre injection, 2 weeks post injection, 6 weeks post injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
Related trials for DeQuervain Tendinopathy
Enrolling by invitation
High and Low Level Laser Therapy in De Quervain's Tenosynovitis
DeQuervain Tendinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Chadderdon, MD principal investigator
OrthoCarolina Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing betamethasone and Ketorolac in people with DeQuervain Tendinopathy, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (VAS) of pain with finklestein test (time frame: 6 weeks post injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.