A Phase 4 interventional study of 25 gauge needle and 22 gauge needle in Osteoarthritis (OA) of the Knee and Fear of Needles, sponsored by University of California, Davis. Not yet recruiting at 1 site in United States. Open to participants aged 40 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by University of California, Davis · Phase 4, Interventional, and Health services research
This study aims to investigate factors that affect the subjective experience of pain during and after intra-articular knee joint injection of steroids by comparing needle gauge size (22 G vs 25 G needles), as well as the presence or absence of topical ethyl chloride spray. Additionally, this study will investigate the effects of other various factors on patients' pain associated with the injection. Lastly, this study aims to determine the effect of patients' subjective pain from the injection on long-term clinical outcomes.
Specific aims are as follows:
Aim 1): Determine the effect of needle gauge size on patient reported pain associated with an ultrasound-guided intra-articular knee injection.
Aim 2): Determine the effect of ethyl chloride spray on patient reported pain associated with an ultrasound-guided intra-articular knee injection.
Aim 3): Determine the effect of sex, age, BMI, thigh size, severity of OA, and fear of needles on patient pain associated with an ultrasound-guided intra-articular knee injection.
Aim 4) Determine the effect of patient pain from the procedure on longer term clinical outcomes after an ultrasound-guided intra-articular knee steroid injection.
Researchers will obtain data at various time points, including pre-procedural data, immediately after the procedure, 24-48 hours after, and 6 weeks post-procedure.
Participants will:
Consent to receiving an intra-articular knee joint injection with steroids if indicated.
Score their "procedural" pain immediately following the procedure, score their post-procedural "soreness" 24-48 hours after via telephone call, and score their overall knee pain about 6 weeks after the procedure via telephone call.
Hypotheses to be tested:
Hypothesis 1): Patients who receive an ultrasound-guided intra-articular knee steroid injection with a 25G needle will report less pain from the procedure at the time of the procedure and less procedure-related pain 24-48 hours after the procedure
Hypothesis 2) Patients who receive an ultrasound-guided intra-articular knee steroid injection with use of ethyl chloride with a given needle gauge will report less pain from the procedure at the time of the procedure and 24-48 hours after the procedure
Hypothesis 3) Higher thigh circumference and fear of needles will be associated with higher levels of pain from the procedure at the time of the procedure and 24-48 hours after the procedure
Hypothesis 4) Higher levels of patient pain during the injection procedure will be associated with lower improvements in knee osteoarthritis pain and knee functional scores at 6 weeks.
There is evidence to suggest that by effectively altering certain parameters and techniques such as needle gauge diameter, speed of administration, and angle of needle during subcutaneous injection of local anesthetic, one can effectively improve the subjective experience of the patient. Evidence also suggests that choice of needle gauge size - which is at the discretion of the practitioner - may be inversely proportional to patient's perception of pain during an injection procedure. Topical anesthesia, such as via the use of ethyl chloride spray (which is also at the discretion of the practitioner), may also modify procedural pain. Furthermore, some studies suggest a correlation between patients' pain during a procedure and their clinical outcomes from the injection.
However, the current research is primarily composed of studies investigating subcutaneous injections (e.g. insulin or vaccination injections) using relatively small needle gauges, or of anesthetic injections in the spine. As such, there is very limited research on factors which may impact peripheral joint injections. Furthermore, there is a paucity of information regarding the effect of patient factors such as age, sex, limb size, anxiety, and fear of needles on the perception of pain during peripheral intra-articular injections.
Additional knowledge regarding the use of different needle gauge and/or the use of local anesthetic may help guide physician treatment patterns with the goal of optimizing patient satisfaction. Additionally, by obtaining subjective data at multiple time points, including 6 weeks post-injection, investigators hope to determine if differences in patient experience with the procedure is associated with patient outcomes.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 88 is close to the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →University of California, Davis is the lead sponsor of 809 studies on the registry; 142 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) 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.
Patients with either
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.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group will receive an intra-articular knee joint injection using a 22 gauge needle, and will be pre-anesthetized with ethyl chloride spray
Procedure: 22 gauge needle · Procedure: +/- Ethyl Chloride Topical Aerosol Anesthetic
This group will receive an intra-articular knee joint injection using a 25 gauge needle, and will be pre-anesthetized with ethyl chloride spray
Procedure: 25 gauge needle · Procedure: +/- Ethyl Chloride Topical Aerosol Anesthetic
This group will receive an intra-articular knee joint injection using a 22 gauge needle, and will be pre-anesthetized with a PLACEBO spray
Procedure: 22 gauge needle · Procedure: +/- Ethyl Chloride Topical Aerosol Anesthetic
This group will receive an intra-articular knee joint injection using a 25 gauge needle, and will be pre-anesthetized with a PLACEBO spray
Procedure: 25 gauge needle · Procedure: +/- Ethyl Chloride Topical Aerosol Anesthetic
This intervention will observe patients post-procedural pain using a 25 gauge needle
This intervention will observe patients post-procedural pain using a 22 gauge needle
This intervention will observe patients post-procedural pain when using topical ethyl chloride spray. This will be compared to a placebo spray which will utilize isopropyl alcohol.
NRPS for injection-related pain at the time of the procedure
NRPS = "Numeric Rating of Pain Scale", scale from 0 to 100. "0" = minimum score, better outcome); "100" (maximum score, worse outcome)
Time frame: immediately following the procedure
NRPS pain 24-48 hours after the procedure at the injection site, assessing injection-related "soreness"
NRPS = "Numeric Rating of Pain Scale", scale from 0 to 100. "0" = minimum score, better outcome); "100" (maximum score, worse outcome)
Time frame: 28-48 hours after the procedure
NPRS score for overall knee pain, and WOMAC functional scores at six weeks post-procedure
NRPS = "Numeric Rating of Pain Scale", scale from 0 to 100. "0" = minimum score, better outcome); "100" (maximum score, worse outcome). WOMAC = "Western Ontario and McMaster Universities Arthritis Index" is a self-administered questionnaire consisting of 24 items divided into 3 subscales. Test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4)
Time frame: 6 weeks following procedure
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, Davis →