An interventional study of Lidocaine and Corticoids in Hand Osteoarthritis, Trigger Finger and Carpal Tunnel Syndrome, sponsored by University of Texas at Austin. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-03.
Sponsored by University of Texas at Austin · Not applicable, Interventional, and Treatment
The purpose of this study was to determine whether adding Lidocaine to Corticosteroid injections reduce pain intensity in hand surgery.
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.
93 studies on the registry are indexed under Trigger Finger Disorder; 22 are open to participants now.
This study's enrollment of 40 is below the median of 66 across 75 interventional studies indexed under Trigger Finger Disorder.
Browse Trigger Finger Disorder studies →University of Texas at Austin is the lead sponsor of 328 studies on the registry; 79 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Drug: Lidocaine · Drug: Corticoids
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)
Drug: Corticoids
The group with the lidocaine will get a combined injection with a corticosteroid and lidocaine. The dosages depend on the disease.
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:
Pain intensity during injection
11-point ordinal scale, with 0 for no pain at all and 10 for worst pain ever
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: through study completion, an average of 6 weeks
Pain intensity 4 hours after injection
11-point ordinal scale, with 0 for no pain at all and 10 for worst pain ever
Time frame: 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
Time frame: 5 minutes after injection
Jefferson scale of patient perception of physician empathy
a 5 item questionnaire of patient's perceived empathy with a range of 5(minimum perceived empathy) to 35( maximum perceived empathy)
Time frame: through study completion, an average of 6 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2020 to primary completion in Jul 2023, 41 months.
Of 34 interventional studies with no phase under Trigger Finger Disorder, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 41. This study's 41 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine
University of Texas at Austin →