Needle Gauge and Anesthetic for Knee Arthritis Injections

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, Davis

Disqualifiers: Arthroscopy, Steroid injection, Hyaluronic acid, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how different factors affect pain during and after knee injections for arthritis. It compares two needle sizes (22 gauge and 25 gauge) and evaluates the use of a numbing spray (ethyl chloride topical aerosol anesthetic) to identify which combination provides more comfort. The study also examines how personal factors, such as fear of needles, might influence pain levels and whether initial pain impacts long-term outcomes. Individuals with knee arthritis who have not used ethyl chloride before and experience knee pain affecting daily activities might be suitable candidates for this trial. As a Phase 4 trial, this research focuses on an FDA-approved treatment to better understand its benefits for a broader patient population.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on knee injections and does not mention any medication restrictions.

What is the safety track record for these treatments?

Research shows that both 22-gauge and 25-gauge needles are generally well-tolerated for knee injections when used with ethyl chloride spray. Studies have found no significant difference in pain levels between the two needle sizes with this spray, indicating both options are equally safe regarding pain.

Ethyl chloride spray, a common numbing agent, helps reduce pain during procedures. It is known to be safe and is usually well-tolerated, with few reports of side effects.

The trial is in a later phase, indicating that the treatment has already passed earlier safety tests. This supports the safety of using these needle sizes and ethyl chloride spray for knee injections. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores how needle gauge and anesthetic spray can impact knee arthritis treatment. Unlike the standard of care, which typically focuses on different medications or physical therapy, this trial investigates the potential benefits of using different needle sizes (22 gauge and 25 gauge) and anesthetic techniques. By comparing injections with and without ethyl chloride spray, researchers aim to determine the most effective and comfortable method for patients. This could lead to more tailored, less painful injection experiences for those with knee arthritis.

What evidence suggests that this trial's treatments could be effective for knee arthritis injections?

This trial will compare different needle gauges and the application of ethyl chloride spray for knee arthritis injections. Research has shown that ethyl chloride spray during knee injections can significantly reduce pain. Studies have found that patients experience less pain with the spray, regardless of needle size. In this trial, some participants will receive injections with a 22-gauge needle, while others will receive a 25-gauge needle, with or without ethyl chloride spray. When the spray is used, there is no noticeable difference in pain between the 22-gauge and 25-gauge needles. This indicates that the spray is more crucial for pain reduction than needle size. Ethyl chloride can make steroid injections for knee arthritis more comfortable for patients. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with knee osteoarthritis who need steroid injections and are not afraid of needles. It's open to adults regardless of sex, age, BMI, or thigh size. However, it excludes those who can't consent to the procedure or follow-up calls.

Inclusion Criteria

I have agreed to receive a knee injection with steroids.

Fulfillment of the American College of Rheumatology criteria for knee OA

I am 40 years old or older.

Exclusion Criteria

I had a knee arthroscopy within the last 6 months.

I have not had a steroid injection in my knee in the last 3 months.

Cognitively impaired individuals

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Participants receive an ultrasound-guided intra-articular knee joint injection with steroids, with variations in needle gauge and use of ethyl chloride spray

1 day

1 visit (in-person)

Immediate Post-Procedure Assessment

Participants score their procedural pain immediately following the procedure

Immediately after procedure

Short-term Follow-up

Participants score their post-procedural soreness 24-48 hours after the procedure via telephone call

24-48 hours

Long-term Follow-up

Participants score their overall knee pain and functional outcomes 6 weeks after the procedure via telephone call

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 22 gauge needle
• 25 gauge needle
• +/- Ethyl Chloride Topical Aerosol Anesthetic

Trial Overview The study tests pain levels during knee injections using different needle sizes (22G vs 25G) and with/without ethyl chloride spray. It also examines how factors like gender, age, body size, arthritis severity affect pain perception and long-term outcomes.

How Is the Trial Designed?

Group I: 25 Gauge Needle WITH Ethyl Chloride spray Experimental Treatment 2 Interventions

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 II: 22 Gauge Needle WITH Ethyl Chloride spray Experimental Treatment 2 Interventions

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 III: 22 Gauge Needle WITHOUT Ethyl Chloride spray Placebo Group 2 Interventions

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 IV: 25 Gauge Needle WITHOUT Ethyl Chloride spray Placebo Group 2 Interventions

This group will receive an intra-articular knee joint injection using a 25 gauge needle, and will be pre-anesthetized with a PLACEBO spray

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Department of Physical Medicine and Rehabilitation

Collaborator

Trials

1

Recruited

90+

Published Research Related to This Trial

A 40 mg intra-articular injection of methylprednisolone acetate (MPA) can provide clinical benefits for knee osteoarthritis symptoms, but careful consideration of factors like pain severity and individual patient circumstances is crucial for effectiveness.

There are significant safety concerns and contraindications associated with MPA injections, especially regarding patients on anticoagulants, highlighting the need for individualized treatment plans and thorough risk-benefit evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Review of Methylprednisolone Acetate Intra-Articular Injection in the Management of Osteoarthritis of the Knee - Part 2: Clinical and Procedural Considerations. McCrum, C.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06865170

Pain Perception During Intra-Articular Knee Joint Injection ... This study aims to investigate factors that affect the subjective experience of pain during and after intra-articular knee joint injection of steroids by ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S187638201730135X

A double-blind, randomized, saline-controlled study of the ... In this study, intra-articular Tr14/Ze14 provided significant pain relief compared to saline-control throughout the observation period.

3. withpower.com withpower.com/trial/phase-4-osteoarthritis-2-2025-e48ea

Needle Gauge and Anesthetic for Knee Arthritis Injections Trial Overview The study tests pain levels during knee injections using different needle sizes (22G vs 25G) and with/without ethyl chloride spray. It also ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7931012/

Intra-Articular Injections in Knee Osteoarthritis - PubMed Central The most frequently reported complications are pain and bleeding at the injection site, while septic arthritis is a rare major complication of ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27986370/

Effects of ethyl chloride spray on early recovery after total ... Several clinical studies reported that use of ethyl chloride has positive effects on swelling, pain reduction and recovery from sports injuries. The main aim ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11956196/

a randomized controlled trial - PMC - PubMed Central This treatment modality has shown long-term benefits in treating intractable knee OA. However, there are few randomized controlled trials to ...

7. ccjm.org ccjm.org/content/ccjom/73/10/897.full.pdf

Intra-articular injections for osteoarthritis of the knee Their data strongly suggest that intra-articular corticosteroid injections reduce the production of interleukin-1, tumor necrosis factor alpha,.