Clinical trial NCT05678101: TENS for Relief of Postoperative Pain in Orthopedic Patients
Official title: Transcutaneous Electrical Nerve Stimulation (TENS) Integrated Into Pants for Relief of Postoperative Pain in Orthopedic Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Orthopedic Disorder
Post Operative Pain
Hip Fractures
Arthroplasty, Replacement, Hip
Internal Fixation
Keywords: transcutaneous electrical nerve stimulation
Patient Global Impression of Change
numeric pain rating scale
TENS
PGIC
NRS
Post Operative Pain
Hip Fractures
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be a prospective, randomized, single-blinded, placebo-controlled repeated measures design.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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, \&amp; 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, \&amp; 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.

The primary aim of this study is to assess pain reduction and patient global impression of change following mixed-frequency TENS treatment (or placebo TENS) at rest and during activity on postoperative days 1 to 3, following hip fracture surgery. A secondary aim is to assess improvement in mobility and to test the opioid-sparing effect associated with TENS treatment. Moreover, to simplify TENS application, empower the elderly patients and improve compliance during mobilization, the authors chose to administer TENS using wearable TENS-pants with modular textile electrodes. We hypothesize that a mixed-frequency TENS intervention, carried out on POD1 to POD3, with a daily treatment duration of 3 hours, can lead to a significant opioid sparing effect, more durable pain reduction, and improve the patients' overall perception and recovery.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pain estimation during rest
timeFrame: 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.
measure: Patient Global Impression of Change (PGIC)
timeFrame: During intervention. Measured twice per round after both TENS-session 'a' and 'b' respectively.
measure: Pain estimation during activity
timeFrame: 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'.
Secondary outcomes:
measure: Mobility testing (Walking test)
timeFrame: 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'.
measure: Analgesic consumption
timeFrame: During intervention. The information will be logged at the end of each day of intervention.
measure: Mobility testing (Put on pants time)
timeFrame: During intervention. Measured once per day: Before the first pain assessment during rest and before TENS-session 'a' of the first round.
measure: Patients-reported impression of TENS (Qualitative assessment)
timeFrame: Immediately after intervention
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska university Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Paul W Ackermann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: