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临床试验/NCT03758300
NCT03758300Unknown不适用

Radiofrequency Facilitates the Prehabilitation Process in Patients Undergoing Total Knee Arthroplasty: Effects on Preoperative and Postoperative Functional Capacity. A Double Blind Randomized Controlled Trial

McGill University Health Centre/Research Institute of the McGill University Health Centre2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2017年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
48
试验地点
2
主要终点
change of 15% of the total distance walked during a 6MWT

研究概览

简要总结

The purpose of this study is to compare the effects of the radiofrequency applied to the sensory innervation of the knee, with respect to a control group (standard therapy), in a prehabilitation program aiming to improve the functional recovery of patients undergoing TKA.

In the present study, the investigators hypothesize that participants treated with radiofrequency 4-6 weeks before the surgery, should be able to effectively accomplish the prehabilitation program and, therefore, have a faster recovery of their functional status in the post operative period , compared with the control group (That use the present state of the art approach)

详细描述

Postoperative functional capacity following TKA surgery has been strongly associated with preoperative functional status. Presence of pain, poor strength and flexibility, and limited ability to complete physiological tasks have been shown to be consistent predictors of poor recovery from knee surgery.

The postoperative period is associated with 30-40% decrease in functional capacity, and efforts have been made to facilitate the recovery by implementing rehabilitative measures over the period of weeks and months. However, the postoperative period might not be the best time to engage patients in intensive physiotherapy as they are easily tired and in pain. Preparing patients for the stress of surgery, called also prehabilitation, is emerging as a mean to optimize pre-operative status and increase functional reserve thus, increasing surgical stress tolerance. Observational and randomized controlled studies in patients scheduled for colorectal, thoracic, and spinal surgeries have suggested that a 4-6 weeks of moderate preoperative physical activity can lead to significant postoperative improvements in cardiorespiratory reserve and functional capacity. However, preliminary trials on the effect of a 6-8 weeks prehabilitation program with structured exercises prior to knee arthroplasty have reported contrasting results, and one of the reasons might be the high levels of pain encountered by these patients while exercising, therefore making it difficult to engage them in achieving effective prehabilitation. It would therefore, make sense if efforts were directed towards relieving pain thus, facilitating broader fitness enhancement strategies and improving the surgical experience and the recovery process.

Common pharmacological methods to relieve osteoarthritic pain while waiting for surgery, include acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDS and Cox-2 inhibitors) and occasionally opioids. Non-surgical interventions, such as intra-articular injection with steroids or hyaluronic acids, acupuncture and periosteal stimulation therapy, are often used as complementary therapies of limited benefit. The use of pulsed and Continuous radiofrequency (PRF and CRF) to the saphenous nerve and the genicular nerves branches of the knee, have been shown to decrease significantly pain scores in 44% of patients with chronic OA of the knee for up to one year after the treatment. Akbasa et al. using the Western Ontario and McMaster Osteoarthritis Index (WOMAC), reported significant reduction of pain at rest, movement and flexion of the knee and increase in patient's satisfaction 6 months after the PRF treatment. Our group has recently demonstrated the benefits of radiofrequency treatment in patients waiting for total knee replacement TKA 9. More so, the investigators recent results reported to the American Society of Regional Anesthesia and Pain, showed in a randomized controlled trial promising results in terms of faster recovery of patients undergoing TKA, when they received RF instead of the standard postoperative analgesia technique 10.

The present study is, as mentioned above, related to an already approved and finished study in this institution: 15-209-MUHC "Functional outcome and postoperative analgesia following total knee arthroplasty: a prospective, randomized, double blind comparison between continuous adductor canal block and pulsed radiofrequency of saphenous and genicular nerves of the knee". In that study, our research group was investigating the effects of the Radiofrequency treatment preoperatively on the postoperative pain and functional recovery, in patients who did not participate in a prehabilitation program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic knee pain, with Dynamic VAS ≥ 5
  • Scheduled for elective total knee arthroplasty
  • Functional impairment due to pain because of knee osteoarthritis
  • Taking medications to control the pain.
  • Ability to perform the 6 MWT.

排除标准

  • ASA physical status > 3
  • Morbid obesity (BMI >40)
  • Revision of total knee arthroplasty
  • Mayor neuropsychiatric disease
  • Mayor cardiac, renal or hepatic failure
  • Anemia (hematocrit <30%)
  • Immunosuppression
  • Rheumatoid arthritis
  • Allergy to opioids, to local anesthetics or other medications used in the study,
  • Chronic regular use of large doses of opioids (>20mg equivalent of morphine/day) or sedatives
  • Unwillingness to have spinal anesthesia
  • History of recent drug abuse
  • Contraindication to receive regional anesthesia (e.g. coagulation defect)
  • Inability to walk before the surgery
  • Inability to perform physical tasks
  • Contraindications to physical exercise and training
  • Prior mayor knee surgery
  • Connective tissue diseases affecting the knee
  • Serious neurologic disorders
  • Injection with steroids or hyaluronic acids during the previous 3 months
  • Active sciatic pain
  • Anticoagulant medications

研究组 & 干预措施

Radiofrequency group

Experimental

In this group patients will receive in a sterile fashion continuous radiofrequency for 4 minutes to the 3 genicular nerves in the operative knee as well as Pulsed Radiofrequency at 42 degrees celsius, for 4 minutes (60-70 volts) to the saphenous nerve and the nerve to the Vastus Medialis, at the level of the adductor canal. The procedure is done under local anesthesia on an ambulatory basis. After the radiofrequency, Ropivacaine 0.5% 5 ml is injected to each one of the nerves, along with 5 milligrams of Methylprednisolone to each nerve. Once the procedure is completed (takes about 20 minutes), patients will be observed in the preoperative program facility for 30 minutes and then discharged home.

干预措施: Radiofrequency (Other)

Control (Sham Radiofrequency) group

Sham Comparator

In this group patients will receive injections of the local anesthetic and steroids in the same anatomical locations, without activating the radiofrequency generator.

干预措施: Radiofrequency (Other)

结局指标

主要结局

change of 15% of the total distance walked during a 6MWT

时间窗: 18 weeks

change of 15% or more in total distance in six minute walk test from baseline

次要结局

  • Change in amount of daily pain relief medication consumption(Baseline and 18 weeks)
  • Change in total time of the time up and go (TUG) test(Baseline and 18 weeks)
  • Change in knee pain levels assessed by VAS (Dynamic/Static)(Baseline and 18 weeks)
  • Change in WOMAC score(Baseline and 18 weeks)

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

JF Asenjo

Professor

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (2)

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