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

NCT ID: NCT06865170

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-05-31
• Study Completion Date: 2026-05-31

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.

Detailed Description

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.

Conditions

Osteoarthritis (OA) of the Knee; Fear of Needles

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

22 gauge needle

Intervention Type: PROCEDURE

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

+/- Ethyl Chloride Topical Aerosol Anesthetic

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

25 gauge needle

Intervention Type: PROCEDURE

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

+/- Ethyl Chloride Topical Aerosol Anesthetic

Intervention Type: 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 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

Group Type: PLACEBO_COMPARATOR

22 gauge needle

Intervention Type: PROCEDURE

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

+/- Ethyl Chloride Topical Aerosol Anesthetic

Intervention Type: 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.

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

Group Type: PLACEBO_COMPARATOR

25 gauge needle

Intervention Type: PROCEDURE

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

+/- Ethyl Chloride Topical Aerosol Anesthetic

Intervention Type: 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.

Interventions

25 gauge needle

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

Intervention Type: PROCEDURE

22 gauge needle

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

Intervention Type: PROCEDURE

+/- Ethyl Chloride Topical Aerosol Anesthetic

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. age ≥ 40 years

2. fulfillment of the American College of Rheumatology criteria for knee OA

3. confirmation of knee-related pain and/or functional loss by clinical examination.

4. Patients with either

1. bilateral knee OA/injections, or

2. unilateral knee OA/injections.

5. Agreed to an intra-articular knee joint injection with steroids

6. Naive to use of ethyl chloride

Exclusion Criteria

1. Arthroscopy of the index knee(s) within the prior 6 months

2. Steroid injection of the knee(s) within the prior 3 months

3. Hyaluronic acid or platelet-rich plasma injection of the knee within the prior 6 months

4. Patient reported prior injection of any type with ethyl chloride spray

5. Knee effusion requiring aspiration at the time of the procedure

6. Cognitively impaired individuals

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UC Davis Sports Medicine Clinic

Sacramento, California, United States

Countries

United States

Facility Contacts

Daniel Herman, MD, PhD

Role: primary

dcherman@ucdavis.edu

919-641-2724

Kevin Nasre, DO, MS

Role: backup

knasre@ucdavis.edu

650-787-3723

Other Identifiers

2200055

Identifier Type: -

Identifier Source: org_study_id