跳至主要内容
临床试验/NCT05678101
NCT05678101进行中(未招募)不适用

Transcutaneous Electrical Nerve Stimulation (TENS) Integrated Into Pants for Relief of Postoperative Pain in Orthopedic Patients

Karolinska University Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
30
试验地点
2
主要终点
Pain estimation during rest

研究概览

简要总结

To ensure early mobilization, minimize suffering, and to prevent postoperative complications postoperative pain should be reduced as soon and as effectively as possible.

A non-pharmacological post-operative intervention in terms of the application of transcutaneous electrical nerve stimulation (TENS), could have the potential to accelerate early mobilization and reduce the use of opioids.

The overall aim is to demonstrate that the addition of TENS to standard postoperative pain management of orthopedic patients can alleviate pain during mobilization and at rest as well as reduce opioid consumption.

详细描述

Hip fracture is most often addressed surgically (Allahabadi et al., 2022; RikshÖFt, 2020), and is commonly associated with a short-term increase in mortality, and long-term reduction in health-related quality of life (Alexiou et al., 2018; Dyer et al., 2016; Gjertsen et al., 2016; Griffin et al., 2015). A large part of this reduction in quality of life can be related to pain and mobility. According to the Swedish National Hip Fracture Registry (RikshÖFt, 2020), 5.8% of the patients registered in 2019 were experiencing severe pain either constantly or during activity at the 4-month follow-up; 42% were experiencing tolerable pain during activity, and 35% were pain-free.

In the larger context of Chronic PostOperative Pain (CPOP), severe pain on postoperative day 1 constitutes an important risk factor (Fletcher et al., 2015). A 10% increase in the amount of time spent in severe pain on postoperative day 1 has been associated with a 30% increase in the incidence of CPOP at a 12-month follow-up. Yet, a 2021 review on the prevention of CPOP (Carley et al., 2021) reported that there were no pharmaceutical pain treatments that could be universally or specifically recommended to reduce the incidence of CPOP.

To effectively manage acute and chronic pain disorders, Transcutaneous Electrical Nerve Stimulation (TENS) has been viewed a safe nonpharmacological addition to standard care (Jafra et al., 2022; Johnson et al., 2022; Vance et al., 2022). Conventional TENS with high frequency (50-100Hz) activates non-noxious afferents considered to inhibit nociceptive transmission at the spinal cord level, i.e., peripheral gate-control. Mixed-frequency TENS adds a low-frequency (mostly 2-10Hz) stimulation that activates small-diameter, high-threshold peripheral afferents considered to trigger brainstem opioid descending pain inhibitory pathways, i.e., central gate-control. Studies have indicated mixed-frequency TENS may be effective to mitigate post-operative pain (Bjordal, Johnson, & Ljunggreen, 2003; Hamza et al., 1999).

A non-pharmacological post-operative intervention in terms of the application of transcutaneous electrical nerve stimulation (TENS), could have the potential to accelerate early mobilization and reduce the use of opioids.

A 2019 study (Elboim-Gabyzon, Najjar, & Shtarker, 2019) demonstrated pain reduction during activity - but not at rest - following hip fracture with a 30-minute TENS intervention daily on the first 5 postoperative days. A more recent (and currently unpublished) study using TENS integrated in TENS-pants (Opolka et al., 2024) demonstrated pain reduction at rest and during activity with a single 2.5-hour intervention carried out around postoperative day 1 (POD1). However, there is there is still a lack of knowledge regarding the possible effect of a longer TENS intervention repeated over several days. Moreover, there is still a lack of statistical evidence for the opioid sparing effect of TENS following hip fracture surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Fifteen of the patients will be randomized to the intervention and 15 will receive placebo (non-active TENS treatment).

入排标准

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

入选标准

  • Patients 18 years and above.
  • Patient has undergone hip fracture surgery.
  • Must be cognitively adequate.
  • Must be without terminal illness.

排除标准

  • Pregnancy
  • Skin wounds
  • Pacemaker
  • Intracardiac defibrillator
  • Ongoing thrombolysis or thromboprophylaxis.
  • Class 3 and 4 heart disease
  • Difficulties to understand the Swedish language
  • Drug and narcotic abuses
  • Postoperative delirium syndrome
  • Epidural catheter.

研究组 & 干预措施

TENS

Active Comparator

The Chattanooga Physio TENS (DJO Global, Vista, CA) will be applied with mixed burst / TENS alternated, which is a 30-minute long program where the stimulation frequencies of alternate in 3 second intervals, producing a combined stimulation of 80 Hz and 2 Hz. Two programs/sessions ('a' and 'b') will be applied in succession for a total of 60-minutes (one round). In total, each day will have 3 rounds.

The energy intensity level will firstly be adjusted for 80 Hz (TENS) until a tingling sensation is felt but no discomfort, and then the procedure will be repeat for 2 Hz.

The patient will use a pair of pants with integrated stimulation electrodes, to which the CE-marked TENS device (Chattanooga Physio, DJO Nordic, Malmö, Sweden) will be connected and used to provide pain relief, in addition to usual postoperative care.

The TENS device will be connected to the textile electrodes of the pants which are located 5cm in front and behind the hip incision dressing respectively.

干预措施: transcutaneous electrical nerve stimulation (TENS) (Device)

Control

Sham Comparator

The control group will also receive the TENS-pants described above with integrated stimulation electrodes, connected to TENS treatment. However, the TENS treatment to the control group will be set such that no electricity will be applied to the patient. In all other regards, the control group will follow the same protocol as the intervention group.

干预措施: Sham transcutaneous electrical nerve stimulation (TENS) (Device)

结局指标

主要结局

Pain estimation during rest

时间窗: During intervention. Mesaured twice per round: First before mobility testing and TENS-session 'a' and a second time during the last 5 minutes of the TENS-session 'a' during inactivity.

A 11-point numeric pain rating scale (Minimum 0, Maximum 10, higher score means worse outcome, i.e more pain) assessment will be performed during inactivity

Patient Global Impression of Change (PGIC)

时间窗: During intervention. Measured twice per round after both TENS-session 'a' and 'b' respectively.

The patient's belief about the efficacy of treatment, which ranged from 1 (minimum, "no change") to 7 (maximum, "a great deal better") will be assessed by PGIC.

Pain estimation during activity

时间窗: During intervention. Measured twice per round: First after mobility testing and before TENS-session 'a' and a second time in the last 5 minutes of TENS-session 'b'.

A 11-point numeric pain rating scale (Minimum 0, Maximum 10, higher score means worse outcome, i.e more pain) assessment will be performed during activity after the Standardized three-meter Walking test (WALK3m)

次要结局

  • Mobility testing (Walking test)(During intervention. Performed and measured twice per round: once before TENS-session 'a' and a second time during the last 5 minutes of TENS-session 'b'.)
  • Analgesic consumption(During intervention. The information will be logged at the end of each day of intervention.)
  • Mobility testing (Put on pants time)(During intervention. Measured once per day: Before the first pain assessment during rest and before TENS-session 'a' of the first round.)
  • Patients-reported impression of TENS (Qualitative assessment)(Immediately after intervention)

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul Ackermann

Professor, MD, PhD

Karolinska University Hospital

研究点 (2)

Loading locations...

相似试验