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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-89
SponsorUniversity of California, Davis

About 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 accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 25 gauge needle

    Procedure/Surgery

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

  • 22 gauge needle

    Procedure/Surgery

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

  • +/- Ethyl Chloride Topical Aerosol Anesthetic

    Procedure/Surgery

    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.

Treatment groups

88 Participants
are divided into 4 treatment groups
Group A: 22 Gauge Needle WITH Ethyl Chloride sprayExperimental treatment 2 interventions
Group B: 25 Gauge Needle WITH Ethyl Chloride sprayExperimental treatment 2 interventions
Group C: 22 Gauge Needle WITHOUT Ethyl Chloride sprayPlacebo comparator 2 interventions
Group D: 25 Gauge Needle WITHOUT Ethyl Chloride sprayPlacebo comparator 2 interventions

Trial outcomes

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)

Time frame
immediately following the procedure

Secondary outcomes

1

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

NRPS = "Numeric Rating of Pain Scale", scale from 0 to 100. "0" = minimum score, better outcome); "100" (maximum score, worse outcome)

Time frame
28-48 hours after the procedure
2

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

NRPS = "Numeric Rating of Pain Scale", scale from 0 to 100. "0" = minimum score, better outcome); "100" (maximum score, worse outcome). WOMAC = "Western Ontario and McMaster Universities Arthritis Index" is a self-administered questionnaire consisting of 24 items divided into 3 subscales. Test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4)

Time frame
6 weeks following procedure

Other outcomes

Sponsors and contacts

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