Pain Perception During Intra-Articular Knee Joint Injection: What is the Effect of Needle Gauge and the Use of Ethyl Chloride?
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- NRPS for injection-related pain at the time of the procedure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •bilateral knee OA/injections, or
- •unilateral knee OA/injections.
- •Agreed to an intra-articular knee joint injection with steroids
- •Naive to use of ethyl chloride
排除标准
- •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
- •Knee effusion requiring aspiration at the time of the procedure
- •Cognitively impaired individuals
研究组 & 干预措施
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
干预措施: +/- Ethyl Chloride Topical Aerosol Anesthetic (Procedure)
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
干预措施: 25 gauge needle (Procedure)
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
干预措施: 22 gauge needle (Procedure)
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
干预措施: +/- Ethyl Chloride Topical Aerosol Anesthetic (Procedure)
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
干预措施: 22 gauge needle (Procedure)
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
干预措施: +/- Ethyl Chloride Topical Aerosol Anesthetic (Procedure)
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
干预措施: 25 gauge needle (Procedure)
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
干预措施: +/- Ethyl Chloride Topical Aerosol Anesthetic (Procedure)
结局指标
主要结局
NRPS for injection-related pain at the time of the procedure
时间窗: immediately following the procedure
NRPS = "Numeric Rating of Pain Scale", scale from 0 to 100. "0" = minimum score, better outcome); "100" (maximum score, worse outcome)
次要结局
- NRPS pain 24-48 hours after the procedure at the injection site, assessing injection-related "soreness"(28-48 hours after the procedure)
- NPRS score for overall knee pain, and WOMAC functional scores at six weeks post-procedure(6 weeks following procedure)