TENS and Perioperative Fracture Patients (TENS)

August 14, 2023 updated by: Wake Forest University Health Sciences

Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Alleviation in Perioperative Fracture Patients

This is a pilot study designed to evaluate the effectiveness of TENS as part of post-operative pain management. Subjects receiving a TENS unit as part of clinical practice will be approached for consent and followed for 12 months.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Transcutaneous electrical nerve stimulation (TENS) is an affordable and non-invasive option for post-operative analgesia. Broadly, TENS devices deliver pulsed electrical impulses across skin to modulate pain. They are theorized to work through different mechanisms at multiple physiologic levels. Centrally, TENS units activate small-diameter sensory afferents (Aδ nerve fibers), which in turn activate descending pain-inhibitory networks. Peripherally, TENS activation of both large- and small-diameter sensory afferents blocks nociceptive signals to the brain and is instead perceived as TENS-induced paresthesias. Finally, TENS efficacy may also be mediated by µ-opioid, 5-hydroxytryptamine (HT)-1, and 5-HT-2 receptors, particularly at low-frequency electrical activity.2

There are inconclusive results for the adjunctive use of TENS to modulate pain, largely because of a relative paucity of high-quality trials and significant inter-study heterogeneity due to non-standardized protocols. Moreover, most studies within the orthopaedic literature have been concentrated primarily within the total knee arthroplasty (TKA) literature and may have limited generalizability to orthopaedic trauma patients. Some studies have shown a trend towards decreased opioid consumption with the adjunctive use of TENS (vs. placebo-TENS or standard care)3,4 while other studies have shown no difference in pain scores in the post-operative period.5-8 To the investigator's knowledge, only two recent randomized clinical trial (RCT)s have been conducted on non-TKA orthopaedic populations, both of which show promise for the use of TENS postoperatively. One prospective double-blind randomized trial on arthroscopic rotator cuff repairs found a 25% reduction in post-operative opioid consumption when TENS was used adjunctively for pain control .9 Another single-blind prospective RCT on Colles' fractures reported greater postoperative pain improvements in patients receiving TENS vs. placebo.10

There is a growing body of evidence to suggest that TENS therapy can reduce post-operative pain after orthopedic procedures. More high-quality studies are needed to strengthen this suggestion and to characterize specific protocols, populations, and orthopedic conditions for which it might work best. Transcutaneous electrical nerve stimulation, if shown to be effective, stands to serve as an affordable non-opioid, non-invasive option for the safe and effective treatment of pain in the orthopaedic trauma patient population.

TENS units are a non-significant risk device and, therefore, do not require an investigational device exemption (IDE) based upon FDA guidance.15-17 The sensor pads will be placed at the same time as the surgical fixation of the study injury. It does not present a potential serious risk to the health and welfare of patients.

Specific Aim 1: To pilot the use of TENS among a postoperative lower extremity injury population as part of multimodal pain management.

Null Hypothesis (H0): TENS cannot be delivered safely among this population. Alternative Hypothesis (HA): TENS can be delivered safely among this population.

Specific Aim 2: To compare utilization of inpatient and outpatient pain medications of patients treated with TENS and historical controls.

H0: Patients treated with TENS will require the same amount of opioids as historical controls.

HA: Patients treated with TENS will require less opioids (lower morphine milligram equivalent - MME) than historical controls during hospitalization and throughout 3-month follow up.

Specific Aim 3: To compare patient-reported outcomes of patients treated with TENS and historical controls.

H0 1: Patients treated with TENS will experience equivalent patient-reported outcomes as compared to historical controls.

HA 1: Patients treated with TENS will experience greater improvement in patient-reported outcomes (PROMIS 29) relative to baseline as compared to historical controls.

H0 2: Patients treated with TENS will report higher pain scores as compared to historical controls.

HA 2: Patients treated with TENS will report equivalent or lower pain scores as compared to historical controls.

This will be a prospective observational study of patients undergoing operative treatment of lower extremity conditions, including fracture fixation, treatment of nonunion, and deformity correction. The study will be conducted at a single Level I trauma center. Enrolled patients will receive TENS postoperatively during hospitalization; TENS units will also be sent home with patients for use throughout recovery. This group will be compared to controls injury-matched from a prospectively collected, historical database on mobility who did not receive treatment with TENS.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This will be a prospective observational study of patients undergoing operative treatment of lower extremity conditions, including fracture fixation, treatment of nonunion, and deformity correction. The study will be conducted at a single Level I trauma center. Enrolled patients will receive TENS postoperatively during hospitalization; TENS units will also be sent home with patients for use throughout recovery. This group will be compared to controls injury-matched from a prospectively collected, historical database on mobility who did not receive treatment with TENS.

Description

Inclusion Criteria:

  • Operative treatment of lower extremity conditions, including fracture fixation, treatment of nonunion, and deformity correction
  • Injury or deformity of the femur, tibia (plateau, shaft, pilon), or hindfoot and ankle
  • Isolated injury
  • Age 18 years or older
  • Able to provide consent

Exclusion Criteria:

  • • Unable to provide consent (no use of LAR)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transcutaneous nerve stimulation (TENS) patients
Patients who received a TENS unit after surgery
Other: Multimodal Pain management including TENS unit
Patient receiving multimodal pain management strategies which includes the use of TENS.
No TENS
Historic controls- Patients who did not receive a TENS unit after surgery
Other: Multimodal Pain management not including TENS unit
Patient receiving multimodal pain management strategies which does not includes the use of TENS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid use
Time Frame: 3 months following TENS unit placement
Total amount of opioid use calculated by converting all opiates to Morphine Milligram Equivalents
3 months following TENS unit placement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient-reported outcomes measurement information system (PROMIS 29) scores
Time Frame: baseline and 3 months
The PROMIS-29 assesses seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and ability to participate in social roles and activities. Each of the seven domains has four questions which are scored on a five-point Likert scale. The PROMIS-29 scales will be scored using a T-score metric method available at the Assessment Center website (http://assessmentcenter.net). A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores mean more of the specific scale's construct, which may indicate a desirable or an undesirable outcome.
baseline and 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Process Measures and Feasibility as measured by patient compliance- Usage
Time Frame: 3 months
Number of times the TENS unit was used each day by patients
3 months
Process Measures and Feasibility as measured by patient compliance- Duration
Time Frame: 3 months
The duration of each TENS unit session as measured in minutes
3 months
Process Measures and Feasibility as measured by patient compliance-Frequency/amplitude
Time Frame: 3 months
The average frequency/amplitude of electrical current for each patient
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Joseph Hsu, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2020

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 13, 2019

First Submitted That Met QC Criteria

December 20, 2019

First Posted (Actual)

December 24, 2019

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00082259
  • 05-19-16E (Other Identifier: Atrium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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