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

NCT06865170 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 2200055
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fear of Needles; Osteoarthritis (OA) of the Knee

Keywords

pain perception; fear of needles; needle gauge; ethyl chloride; corticosteroid injection; 25G versus 22G

Outcome Measures

Primary Outcomes (1)

• 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)

  immediately following the procedure

Secondary Outcomes (2)

• NRPS pain 24-48 hours after the procedure at the injection site, assessing injection-related "soreness"

  28-48 hours after the procedure

• NPRS score for overall knee pain, and WOMAC functional scores at six weeks post-procedure

  6 weeks following procedure

Study Arms (4)

22 Gauge Needle WITH Ethyl Chloride spray

EXPERIMENTAL

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

25 Gauge Needle WITH Ethyl Chloride spray

EXPERIMENTAL

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

22 Gauge Needle WITHOUT Ethyl Chloride spray

PLACEBO COMPARATOR

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

25 Gauge Needle WITHOUT Ethyl Chloride spray

PLACEBO COMPARATOR

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

Interventions

25 gauge needle PROCEDURE

This intervention will observe patients post-procedural pain using a 25 gauge needle

25 Gauge Needle WITH Ethyl Chloride spray; 25 Gauge Needle WITHOUT Ethyl Chloride spray

22 gauge needle PROCEDURE

This intervention will observe patients post-procedural pain using a 22 gauge needle

22 Gauge Needle WITH Ethyl Chloride spray; 22 Gauge Needle WITHOUT Ethyl Chloride spray

+/- 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.

22 Gauge Needle WITH Ethyl Chloride spray; 22 Gauge Needle WITHOUT Ethyl Chloride spray; 25 Gauge Needle WITH Ethyl Chloride spray; 25 Gauge Needle WITHOUT Ethyl Chloride spray

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 40 years
• fulfillment of the American College of Rheumatology criteria for knee OA
• confirmation of knee-related pain and/or functional loss by clinical examination.
• Patients with either
• bilateral knee OA/injections, or
• unilateral knee OA/injections.
• Agreed to an intra-articular knee joint injection with steroids
• Naive to use of ethyl chloride

You may not qualify if:

• Arthroscopy of the index knee(s) within the prior 6 months
• Steroid injection of the knee(s) within the prior 3 months
• Hyaluronic acid or platelet-rich plasma injection of the knee within the prior 6 months
• Patient reported prior injection of any type with ethyl chloride spray
• Knee effusion requiring aspiration at the time of the procedure
• Cognitively impaired individuals

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Sports Medicine Clinic

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Iatrophobia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: March 7, 2025
• Study Start: May 1, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

US (1)