Pain Perception During Intra-Articular Knee Joint Injection: What is the Effect of Needle Gauge and the Use of Ethyl Chloride?

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT06865170
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Fear of Needles
  • Osteoarthritis (OA) of the Knee

Eligibility Criteria

Sex
ALL
Age
40 Years - 89 Years
Healthy Volunteers
Accepted

Interventions

  • 25 gauge needle — PROCEDURE
    This intervention will observe patients post-procedural pain using a 25 gauge needle
  • 22 gauge needle — PROCEDURE
    This intervention will observe patients post-procedural pain using a 22 gauge needle
  • +/- Ethyl Chloride Topical Aerosol Anesthetic — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Jan 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: 22 Gauge Needle WITH Ethyl Chloride spray
    This group will receive an intra-articular knee joint injection using a 22 gauge needle, and will be pre-anesthetized with ethyl chloride spray
  • Experimental: 25 Gauge Needle WITH Ethyl Chloride spray
    This group will receive an intra-articular knee joint injection using a 25 gauge needle, and will be pre-anesthetized with ethyl chloride spray
  • Placebo Comparator: 22 Gauge Needle WITHOUT Ethyl Chloride spray
    This group will receive an intra-articular knee joint injection using a 22 gauge needle, and will be pre-anesthetized with a PLACEBO spray
  • Placebo Comparator: 25 Gauge Needle WITHOUT Ethyl Chloride spray
    This group will receive an intra-articular knee joint injection using a 25 gauge needle, and will be pre-anesthetized with a PLACEBO spray

Primary Outcome Measure

NRPS for injection-related pain at the time of the procedure [ Time Frame: immediately following the procedure ]

Locations (1)

FacilityCityStateZIPSite coordinators
UC Davis Sports Medicine ClinicSacramentoCalifornia95817
Daniel Herman, MD, PhD
[email protected]
919-641-2724
Kevin Nasre, DO, MS
[email protected]
650-787-3723
Daniel Herman, MD, PhD (PRINCIPAL_INVESTIGATOR)
Kevin Nasre, DO, MS (SUB_INVESTIGATOR)

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By research site
UC Davis Sports Medicine Clinic· Sacramento, CA

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