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

Study Purpose

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.#46;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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 40 Years - 89 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06865170
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of California, Davis
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Osteoarthritis (OA) of the Knee, Fear of Needles
Additional Details

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.

Arms & Interventions

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

Interventions

Procedure: - 25 gauge needle

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

Procedure: - 22 gauge needle

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UC Davis Sports Medicine Clinic, Sacramento, California

Status

Address

UC Davis Sports Medicine Clinic

Sacramento, California, 95817

Site Contact

Daniel Herman, MD, PhD

[email protected]

919-641-2724

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