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Could turning nerve stimulation on and off beat continuous therapy for chronic pain?

NCT ID NCT04909138

Symptom relief Sponsor: Rush University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether using a nerve stimulator in short bursts (30 seconds on, 90 seconds off) can provide the same or better pain relief as continuous stimulation. It involves 30 adults who have had a dorsal root ganglion stimulator for at least a year and report at least 50% pain relief. Participants will try two different stimulation frequencies (20 Hz and 5 Hz) in a crossover design to see which works best.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Jun 2027

An estimate. End dates often move.

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.

Ages

18 to 90 years

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: * Age between 18 and 99 * 1-year or more use of continuous DRG therapy as delivered a permanently implanted Abbott PROCLAIM XR Dorsal Root Ganglion Neurostimulator System for chronic back and/or leg pain * Endorse at least 50% pain relief in the targeted area over the last year * Must have been seen for routine follow-up within last 4 months * Must have been reprogrammed in standard fashion at least once prior to randomization * Willing and able to complete protocol requirements, including: * Complete health questionnaires and pain scales as specified in the protocol * Sign the study-specific informed consent form * Complete follow-ups at the designated time periods Exclusion Criteria: * Significant lead migration, as determined by clinician * Other concurrent neuromodulation system in place * Corticosteroid injection in previous 30 days prior to enrollment * Intermittent dosing and/or failure within last 6m * Changing or unstable pain medications within 30 days

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Conditions

The condition(s) this trial relates to.

Chronic Pain complex regional pain syndrome peripheral nervous system disorder peripheral neuropathy radiculopathy

As listed by the trial registrant

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

CRPS (complex regional pain syndromes) Peripheral neuropathy Radiculopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60612, United States

More trials for these conditions

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