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

88 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment using different needle gauges and anesthetic for knee arthritis injections?

The research suggests that using the correct needle size is important for effective treatment, as incorrect placement can cause discomfort and reduce effectiveness. Additionally, intraarticular injections have been shown to significantly reduce pain in knee conditions, indicating potential benefits for knee arthritis. ^{1 2 3 4 5}

Is it safe to use different needle gauges and anesthetics for knee arthritis injections?

Research suggests that using different needle sizes and anesthetics for injections is generally safe, but the choice of needle size can affect the procedure's effectiveness and comfort. Intra-articular injections, like those for knee arthritis, should be tailored to individual needs, and while some anesthetics have been shown to be safe in animal studies, it's important to discuss potential risks and benefits with a healthcare provider. ^{2 6 7 8 9}

How does the needle gauge treatment for knee arthritis differ from other treatments?

This treatment for knee arthritis uses different needle sizes (22 gauge and 25 gauge) for injections, which may affect the accuracy and comfort of the procedure. The choice of needle gauge can influence the precision of the injection into the knee joint, potentially improving the effectiveness of the treatment compared to other methods that do not consider needle size. ^{1 3 10 11 12}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Intradural anesthesia with a 27-gauge Sprotte needle for arthroscopic knee surgery in ambulatory patients under 40 years of age]. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Needle size for vaccination procedures in children and adolescents. [2018]

3. Thailand pubmed.ncbi.nlm.nih.gov

The Accuracy of Intra-Articular Needle Placements in Osteoarthritic Knee Patients: An Arthroscopic Assessment. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical effect of warm needle penetration in treating knee osteoarthritis. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

The outcomes and cost-effectiveness of intraarticular injection of the rheumatoid knee. [2021]

6. England 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. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Needle size for vaccination procedures in children and adolescents. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Pen needle preference in a population of Canadians with diabetes: results from a recent patient survey. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Editorial Commentary: New Perspectives on the Intra-articular Use of Local Anesthetics: Five Weekly Injections of 0.5% Bupivacaine Does Not Alter Articular Cartilage. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

The most accurate approach for intra-articular needle placement in the knee joint: a systematic review. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Knee aspiration and injection. [2010]

12. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Knee Injections Are More Accurate Than Blind Injections: A Systematic Review of Randomized Controlled Trials. [2022]