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Shockingly simple: TENS device may cut opioid use after broken bone surgery

NCT ID NCT04209673

Symptom relief Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a TENS unit, a small device that sends gentle electrical pulses to the skin, can help manage pain after surgery for broken leg bones. 205 adults who had surgery for fractures of the thigh, shin, or ankle were followed for a year. Researchers measured how much opioid pain medicine they used and how they rated their pain and daily function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

205 people

The number who actually took part.

Started

Jan 2020

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Musculoskeletal Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Musculoskeletal pain

Contacts and locations

Locations

  • Carolinas Medical Center, Department of Orthopaedic Surgery

    Charlotte, North Carolina, 28204, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.