TENS for Relief of Postoperative Pain in Orthopedic Patients

NCT ID: NCT05678101

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2025-12-30

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, & 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.

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.

Conditions

Orthopedic Disorder; Post Operative Pain; Hip Fractures; Arthroplasty, Replacement, Hip; Internal Fixation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TENS

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.

Group Type: ACTIVE_COMPARATOR

transcutaneous electrical nerve stimulation (TENS)

Intervention Type: DEVICE

Chattanooga Physio TENS (DJO Global, Vista, CA)

Control

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.

Group Type: SHAM_COMPARATOR

Sham transcutaneous electrical nerve stimulation (TENS)

Intervention Type: DEVICE

Sham treatment with Chattanooga Physio TENS (DJO Global, Vista, CA)

Interventions

transcutaneous electrical nerve stimulation (TENS)

Chattanooga Physio TENS (DJO Global, Vista, CA)

Intervention Type: DEVICE

Sham transcutaneous electrical nerve stimulation (TENS)

Sham treatment with Chattanooga Physio TENS (DJO Global, Vista, CA)

Intervention Type: DEVICE

Other Intervention Names

electrical nerve stimulation

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Paul Ackermann

Professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul W Ackermann, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

Karolinska university Hospital

Stockholm, , Sweden

Countries

Sweden

References

Opolka Y, Sundberg C, Juthberg R, Olesen A, Guo L, Persson NK, Ackermann PW. Transcutaneous Electrical Nerve Stimulation Integrated into Pants for the Relief of Postoperative Pain in Hip Surgery Patients: A Randomized Trial. Pain Res Manag. 2024 Jun 27;2024:6866549. doi: 10.1155/2024/6866549. eCollection 2024.

Reference Type: DERIVED

PMID: 39145150 (View on PubMed)

Other Identifiers

2023-ORTHTENS

Identifier Type: -

Identifier Source: org_study_id