Trigger Point Injection in Reducing Pain Following Total Knee Arthroplasty
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Pain Scores on the Visual Analog Scale
研究概览
简要总结
This study will evaluate the ability of trigger point injections completed immediately following a total knee arthroplasty decrease pain scores and opioid use compared to sham injections. Given the current state of opioid dependency in the United States there needs to be a more focused attempt at treating post-operative pain without use of opioids. Given the manipulation of soft tissue during a total knee arthroplasty there seems to be a high correlation with pain and myofascial pain syndrome. This study will include an experimental (trigger point injection) and control (sham injection) group who are all undergoing a total knee arthroplasty. This is a pilot study that will include a maximum of 100 total patients (although it is planned for the study to be much smaller with a planned 10-15 patients per group). The procedure that will be completed is a trigger point injection with use of 1% lidocaine without epinephrine along the distal aspect of the vastus medialis and lateralis, proximal aspect of the medial and lateral gastrocnemius muscle bellies. The sham injection will be completed by pressing the needle against the skin without injecting any fluid. There will be a "blind" between the patient and the needle with both arms of the study. These patients will be followed up on POD1, and during weeks 2 and 6 follow-up where they will be given questionnaires to assess pain (visual analogue scale) and opioid use, and asked to bring their opioid medications to the clinic to assess the morphine milligrams equivalent (MME).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 45 years or older
- •Planned to undergo primary total knee arthroplasty
- •Able to speak, read, and understand English
- •Willing to complete a study questionnaires
- •Willing to bring in their medications to be counted
- •DoD beneficiaries
- •No allergy to lidocaine
- •Not fearful of needles.
排除标准
- •Chronic opioid users (daily use of prescribed opioids for at least 90 days)
- •Diagnosed with Fibromyalgia
- •Non-English speaking
- •Unable to read English
- •Unable to understand English
- •Allergy to lidocaine
- •Not willing to complete study questionnaires
- •Not willing to bring in their medications to be counted
- •Not a DoD beneficiary
- •Fearful of needles
研究组 & 干预措施
Experimental group - participants receiving trigger point injections
The participant will receive trigger point injections with 1% lidocaine without epinephrine in two muscles in the thigh and two muscles in the calf immediately after having knee replacement surgery.
干预措施: Trigger point injection (lidocaine) (Drug)
Sham comparator - Participants not receiving trigger point injections
The patient will not receive an injection, but instead a façade of an injection by having the same physical set-up to prepare for an injection (the same as for the experimental group), but there will be a barrier between the patient's view and the syringe so that he/she will not know an injection was not given.
干预措施: Sham Comparator (Other)
结局指标
主要结局
Pain Scores on the Visual Analog Scale
时间窗: From enrollment to the end of treatment at 6 weeks
1\. Change in Visual Analog Scale (VAS) pain scores The VAS is a numbered scale assessing pain severity using a number which describes the average level of pain since being discharged. Participants are to put a hash mark "/" on a numbered scale ranging from 0-100. Zero (0) is no pain and 100 is severe intolerable pain
次要结局
- Opioid Use(From enrollment to the end of treatment at 6 weeks)
