Hand OsteoarthritisNCT06188221
Does Adding Lidocaine to Corticosteroid Injections Reduce Pain Intensity in Hand Surgery
A study testing Lidocaine and Corticoids in people with Hand Osteoarthritis and Trigger Finger, run by University of Texas at Austin at 1 site in United States.
Trial summary
The purpose of this study was to determine whether adding Lidocaine to Corticosteroid injections reduce pain intensity in hand surgery. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Osteoarthritis, Trigger Finger, Carpal Tunnel Syndrome
- What is being tested?
- Lidocaine and Corticoids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 1 Jul 2023
- Phase
- Interventional
- 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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients offered a steroid injection in a hand surgeon's office
- Aged 18-89 years
- English speaking patients
- Able to provide informed consent
Who cannot join
- Non-English/Spanish speakers
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Austin (UTHA)
Austin, Texas, 78701
About this study
The purpose of this study was to determine whether adding Lidocaine to Corticosteroid injections reduce pain intensity in hand surgery.
Read the detailed description
There is a lack of evidence about the use of lidocaine injection as an addition to steroids against pain during injections. Adding lidocaine adds to the volume of the injection, which might increase pain. It's possible that injecting cortisone without any lidocaine would be more comfortable than with lidocaine.
The aim of this randomized controlled trial is to assess the difference in pain intensity (during the injection and 4 hours later) between patients receiving a corticosteroid injection with or without lidocaine in patients with a hand condition. Secondarily, the aim of this study is to assess factors independently associated with pain intensity, satisfaction with the visit, and perceived empathy.
- Conditions
- Hand Osteoarthritis, Trigger Finger, Carpal Tunnel Syndrome
- Being tested
- Lidocaine, Corticoids
- Medical subject headings
- Trigger Finger Disorder, Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
The group with the lidocaine will get a combined injection with a corticosteroid and lidocaine. The dosages depend on the disease.
CorticoidsDrug
The group without the lidocaine will get an injection with only corticosteroids. The corticosteroid dosage depends on the disease and will be the same as for the group with the lidocaine:
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid with Lidocaine | Experimental | The group with the lidocaine will get a combined injection with a steroid and lidocaine. The dosages depend on the disease. The steroid dosage will be the same as for the group without lidocaine.
* Trigger finger/De Quervain's tenosynovitis/Tendonitis: 20mg kenalog (0.5mL of kenalog 40mg/mL suspension) + 5mg lidocaine (0,5mL 10mg/mL lidocaine solution)
* Carpal tunnel injections: 6mg betamethasone (1mL of betamethasone 6mg/mL suspension) + 20mg lidocaine (2mL 10mg/mL lidocaine solution)
* CMC/Basal joint arthritis: 3mg betamethasone (0.5mL of betamethasone 6mg/mL suspension) + 5mg lidocaine (0,5mL 10mg/mL lidocaine solution) Receives: Drug: Lidocaine; Drug: Corticoids |
| Corticosteroid without Lidocaine | Active comparator | The group without the lidocaine will get an injection with only steroids. The steroid dosage depends on the disease and will be the same as for the group with the lidocaine:
* Trigger finger/De Quervain's tenosynovitis/Tendonitis: 20mg kenalog (0,5mL of kenalog 40mg/mL suspension)
* Carpal tunnel injections: 6mg betamethasone (1mL of betamethasone 6mg/mL suspension)
* CMC/Basal joint arthritis: 3mg betamethasone (0,5mL of betamethasone 6mg/mL suspension) Receives: Drug: Corticoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity during injection
11-point ordinal scale, with 0 for no pain at all and 10 for worst pain ever
Measured: During Injection
Pain Catastrophizing Scale (PCS 4)
A 4 item questionnaire with a range of 0(no pain catastrophizing thoughts) to 16(maximum pain catastrophizing thoughts)
Measured: through study completion, an average of 6 weeks
Patient Health Questionnaire (PHQ 2)
a 2 item questionnaire measuring depression symptoms with a range of 0(no depression symptoms
0 to 6(maximum depression symptoms)
Measured: through study completion, an average of 6 weeks
Pain Self-efficacy Questionnaire (PSEQ 2)
A measure of effective coping strategies with a range of 0(no coping strategy) to 12(maximum coping strategies)
Measured: through study completion, an average of 6 weeks
Secondary outcomes (2)
Pain intensity 4 hours after injection
11-point ordinal scale, with 0 for no pain at all and 10 for worst pain ever
Measured: 4 hours after injection
Pain intensity 5 minutes after injection
11-point ordinal scale, with 0 for no pain at all and 10 for worst pain ever
Measured: 5 minutes after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Feb 2020
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in two groups for the corticosteroid injection, one group with lidocaine and one group without lidocaine.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Ring, University of Texas at Austin
- Investigators
- David Ring, MD, PhD, Principal investigator, UT Health Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188221
- Sponsor's protocol ID
- 2019-05-0094
- Status last verified
- Dec 2023
- First submitted
- 8 Jul 2019
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Adding Lidocaine to Corticosteroid Injections Reduce Pain Intensity in Hand Surgery
- ClinicalTrials.gov ID
- NCT06188221
- Acronym / sponsor ID
- 2019-05-0094
- Conditions
- Hand Osteoarthritis, Trigger Finger, Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 3 Jan 2024 (actual)
- 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 was to determine whether adding Lidocaine to Corticosteroid injections reduce pain intensity in hand surgery.
Detailed description
There is a lack of evidence about the use of lidocaine injection as an addition to steroids against pain during injections. Adding lidocaine adds to the volume of the injection, which might increase pain. It's possible that injecting cortisone without any lidocaine would be more comfortable than with lidocaine.
The aim of this randomized controlled trial is to assess the difference in pain intensity (during the injection and 4 hours later) between patients receiving a corticosteroid injection with or without lidocaine in patients with a hand condition. Secondarily, the aim of this study is to assess factors independently associated with pain intensity, satisfaction with the visit, and perceived empathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Patients will be randomized in two groups for the corticosteroid injection, one group with lidocaine and one group without lidocaine.
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid with Lidocaine | Experimental | Drug: Lidocaine, Drug: CorticoidsThe group with the lidocaine will get a combined injection with a steroid and lidocaine. The dosages depend on the disease. The steroid dosage will be the same as for the group without lidocaine. * Trigger finger/De Quervain's tenosynovitis/Tendonitis: 20mg kenalog (0.5mL of kenalog 40mg/mL suspension) + 5mg lidocaine (0,5mL 10mg/mL lidocaine solution) * Carpal tunnel injections: 6mg betamethasone (1mL of betamethasone 6mg/mL suspension) + 20mg lidocaine (2mL 10mg/mL lidocaine solution) * CMC/Basal joint arthritis: 3mg betamethasone (0.5mL of betamethasone 6mg/mL suspension) + 5mg lidocaine (0,5mL 10mg/mL lidocaine solution) |
| Corticosteroid without Lidocaine | Active comparator | Drug: CorticoidsThe group without the lidocaine will get an injection with only steroids. The steroid dosage depends on the disease and will be the same as for the group with the lidocaine: * Trigger finger/De Quervain's tenosynovitis/Tendonitis: 20mg kenalog (0,5mL of kenalog 40mg/mL suspension) * Carpal tunnel injections: 6mg betamethasone (1mL of betamethasone 6mg/mL suspension) * CMC/Basal joint arthritis: 3mg betamethasone (0,5mL of betamethasone 6mg/mL suspension) |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients offered a steroid injection in a hand surgeon's office
- Aged 18-89 years
- English speaking patients
- Able to provide informed consent
Key exclusion criteria (1 listed)
- Non-English/Spanish speakers
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 |
|---|---|---|
| LidocaineThe group with the lidocaine will get a combined injection with a corticosteroid and lidocaine. The dosages depend on the disease. | Drug | Corticosteroid with Lidocaine |
| CorticoidsThe group without the lidocaine will get an injection with only corticosteroids. The corticosteroid dosage depends on the disease and will be the same as for the group with the lidocaine: | Drug | Corticosteroid with Lidocaine, Corticosteroid without Lidocaine |
Primary outcome
Pain intensity during injection
Time frame: During Injection
11-point ordinal scale, with 0 for no pain at all and 10 for worst pain ever
Pain Catastrophizing Scale (PCS 4)
Time frame: through study completion, an average of 6 weeks
A 4 item questionnaire with a range of 0(no pain catastrophizing thoughts) to 16(maximum pain catastrophizing thoughts)
Patient Health Questionnaire (PHQ 2)
Time frame: through study completion, an average of 6 weeks
a 2 item questionnaire measuring depression symptoms with a range of 0(no depression symptoms 0 to 6(maximum depression symptoms)
Pain Self-efficacy Questionnaire (PSEQ 2)
Time frame: through study completion, an average of 6 weeks
A measure of effective coping strategies with a range of 0(no coping strategy) to 12(maximum coping strategies)
2 secondary outcomes
Pain intensity 4 hours after injection
Time frame: 4 hours after injection
Pain intensity 5 minutes after injection
Time frame: 5 minutes after 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 3 Jan 2024.
- Individual participant dataSharing planned: No
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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.
David Ring, MD, PhD principal investigator
UT Health Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine and Corticoids in people with Hand Osteoarthritis and Trigger Finger, run by University of Texas at Austin 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 4 inclusion and 1 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 3 Jan 2024. 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.
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?
Pain intensity during injection (time frame: During Injection). The study lists 4 primary outcomes in all. 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 3 Jan 2024.