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临床试验/NCT02740738
NCT02740738已完成不适用

Preoperative Pain Threshold and Rapid Recover Programs in Total Joint Arthroplasty

Duke University2 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
201
试验地点
2
主要终点
physical therapy performance on the first day after surgery

研究概览

简要总结

To investigate the association between grip strength and preoperative pain threshold as measured by pressure algometer and validated pain outcome surveys.

详细描述

A minimum of 200 patients, 100 hip and 100 knee arthroplasty participants, will be recruited for this study. Preoperatively, patient pain threshold will be recorded both objectively (Pressure algometer) and subjectively (brief pain inventory). In terms of location, objectively this will be tested during the preoperative visit in clinic by the approved, trained research staff, as well as the subjective brief pain inventory.

Objective pain measure: Pressure algometer will be obtained in the standard fashion as follows: the probe is applied at a 90 degree angle to the skin at a constant rate of 10kPa/s to minimize the impact of the examiner's reaction time on recorded pain thresholds. The participant is instructed by the measurer to say "stop" when the sensation of pressure became the very first sensation of pain. There will be three spots to test patients, one for familiarity of the testing and the other 2 for data collection.

  1. This is initially performed once on ipsilateral the tibialis anterior as a "warm up."
  2. Then 3 measurements are taken on the operative medial epicondyle (for TKA) or ipsilateral lateral iliac crest (for THA) and averaged for the official score.
  3. Lastly, three measurements are also taken on the contralateral olecranon to measure systemic pain sensitivity. If the contralateral elbow has had prior surgery or active bursitis, the ipsilateral elbow will be used. Of important note, the algometer has a max force lock out of 100N to prevent any harm to the patient.
  4. Dominant Hand Grip strength measured by the average of 3 attempts on a Dynamometer.

Subjectively, the brief pain inventory is a validated pain outcome measure which will be filled out by the participant during their preoperative clinic visit.

Postoperative, the study team will ask the participant at the 6 week mark:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • any participant undergoing elective primary total knee arthroplasty or total hip arthroplasty
  • Participants of the following investigators will be approached: Bolognesi, Wellman, Attarian, and Seyler

排除标准

  • previous hip or knee surgery in the operative joint

结局指标

主要结局

physical therapy performance on the first day after surgery

时间窗: post op day 1

distance walked in feet on post op day 1

pain control average visual analogue scale 1 - 10 of hospital stay

时间窗: 1-3 days on average

averaging the subjective pain control

Inpatient length of stay in days

时间窗: 1-3 on days average

amount of time in hospital

discharge location placement

时间窗: 1 - 3 days on average

home, rehab or nursing facility

次要结局

  • Outpatient narcotic consumption multiple refills needed(6-week from surgery)
  • Outpatient narcotic pill consumption(6-week from surgery)
  • Outpatient narcotic consumption refill needed(6-week from surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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