Chronic, Intractable Back Pain and/or Leg PainPhase 4MEDNCT06897280
Clinical Trial of MED HF10™ Spinal Cord Stimulation for the Treatment of Chronic Pain
A Phase 4 study testing SCS Device Program Setting in people with Chronic, Intractable Back Pain and/or Leg Pain, run by Nevro Corp at 1 site in United States.
Trial summary
This is a single-center, prospective, non-randomized exploratory study in subjects with chronic, intractable back pain and/or leg pain per the center's routine practice. The primary endpoint is the distribution of responders by 'lowest preferred pulse dose (PD)' setting, where a subject is a responder to the lowest PD… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic, Intractable Back Pain and/or Leg Pain
- What is being tested?
- SCS Device Program Setting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2021to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been diagnosed with chronic, intractable pain of the back pain with or without leg pain
- Have been implanted with the Nevro Senza™ or Omnia SCS system with dual leads, approximately over vertebral T8-T11, for at least 3 months, and are using the system with single area, continuous 10 kHz stimulation programs at least 18 hours daily, as determined by subject reporting and confirmation via device diagnostics, for at least 21 days prior to enrolling in this study
- If taking them, be on stable chronic pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in the study and be willing to stay on those medications with no dose adjustments until study completion or study withdrawal, whichever comes first.
- Be 18 years of age or older at the time of enrollment
- Be willing and able to comply with study-related requirements, procedures, and visits
- Be capable of subjective evaluation, able to read and understand IRB approved written questionnaires, and are able to read, understand and sign the IRB approved written informed consent, all of which will be in American English
Show all 9Show fewer
- Be compliant in using the patient programmer and recharger as determined by the Investigator.
- As determined by the Investigator, be compliant in adjusting programs using the device remote control.
- Have >= 30% pain relief in primary pain area intended to be treated by SCS.
Who cannot join
- Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as
- Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome.
- Have a current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumor, central deafferentation syndrome, Complex Regional Pain Syndrome, or acute herniating disc, as determined by the investigator.
- Having any clinical evidence mechanical instability or progressive neurologic pathology that warrants surgical intervention.
- Having undergone an interventional procedure and/or surgery to treat back or leg pain other than Senza HF10 therapy in the last 30 days
- Have a condition currently requiring or likely to require diathermy
Show all 16Show fewer
- Have a condition currently requiring or likely to require surgery during the study period.
- Have metastatic malignant disease or active local malignant disease
- Have a life expectancy of less than 1 year
- Have an active systemic or local infection
- Be pregnant or planning to become pregnant during the course of the study (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal)
- Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs)
- Be concomitantly participating or planned to be participating in another clinical study overlapping in time with the present clinical study
- Have an existing drug pump and/or another active implantable device (switched On or Off) such as a pacemaker or other non-Senza™ SCS devices
- Have an unresolved condition of device-related pain (e.g. IPG pocket
- Have a condition currently requiring or likely to require surgery during the study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Neuroscience Research Center
Overland Park, Kansas, 66210
About this study
Official title: A Single-Center, Prospective Clinical Trial of MED HF10™ Spinal Cord Stimulation for the Treatment of Chronic Pain
This is a single-center, prospective, non-randomized exploratory study in subjects with chronic, intractable back pain and/or leg pain per the center's routine practice. The primary endpoint is the distribution of responders by 'lowest preferred pulse dose (PD)' setting, where a subject is a responder to the lowest PD setting they preferred prior to entering the Observational period. The study is performed in patients who already have Nevro SCS devices implanted.
- Being tested
- SCS Device Program Setting
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCS Device Program SettingDevice
Also called Pulse Dose Setting
A Pulse Dose setting specifies a brief duration of stimulation 'on' and stimulation 'off' durations, applied in a continuously cycled manner
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Pulse Dosing Receives: Device: SCS Device Program Setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preference for Pulse Dose Setting
Starting from a standardized low pulse dose (PD) setting, subjects will try progressively lower PD settings depending upon their response to each setting, to arrive at the lowest PD setting they prefer. Up to 5 PD settings will be tried by each subject.
Measured: 3 months
Secondary outcomes (7)
Numerical Rating Scale of Back, Leg, and Overall Pain Intensity
The numerical rating scale ranges from 0 to 10, where 0 = no pain and 10 = worst pain imaginable.
Measured: 3 months
Patient Satisfaction
The subject will rate their satisfaction with the SCS program on a scale from "Very Satisfied," "Satisfied," "Not Sure," "Dissatisfied," to "Very Dissatisfied."
Measured: 3 months
Patient Global Impression of Change
This 7-point scale is used to assess the subject's global change in their general state of health for each particular phase of the study. Responses range from "Very Much Worse" to "No Change" to "A Great Deal Better".
Measured: 3 months
Oswestry Disability Index
The Oswestry Disability Index (ODI) uses 10 questions covering aspects of daily life affected by back pain, such as pain intensity, personal care, lifting, walking, and social activities. Each question is scored on a 0-5 scale, with higher scores indicating greater disability. The total score is calculated as a percentage, with 0% representing no disability and 100% representing complete disability. Outcomes will be categorized as follows: 0-20%: Minimal disability; 21-40%: Moderate disability; 41-60%: Severe disability; 61-80%: Crippled; 81-100%: Bedridden.
Measured: 3 months
Patient Catastrophizing Scale
Subjects are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52), along with three subscale scores assessing rumination, magnification and helplessness.
Measured: 3 months
PROMIS-SF Sleep Disturbance Scale
Each of the 8 items on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Measured: 3 months
Daily device recharge duration
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start16 Nov 2021
- Primary completion16 Nov 2024
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic, Intractable Back Pain and/or Leg PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nevro Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mayank Gupta, MD, Principal investigator, Neuroscience Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897280
- Sponsor's protocol ID
- 1309273
- Other IDs
- MED IIS
- Acronym
- MED
- Status last verified
- Jun 2026
- First submitted
- 10 Mar 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective Clinical Trial of MED HF10™ Spinal Cord Stimulation for the Treatment of Chronic Pain
- ClinicalTrials.gov ID
- NCT06897280
- Acronym / sponsor ID
- MED / 1309273
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Nevro CorpIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 16 Nov 2024 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, prospective, non-randomized exploratory study in subjects with chronic, intractable back pain and/or leg pain per the center's routine practice. The primary endpoint is the distribution of responders by 'lowest preferred pulse dose (PD)' setting, where a subject is a responder to the lowest PD setting they preferred prior to entering the Observational period. The study is performed in patients who already have Nevro SCS devices implanted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: SCS Device Program SettingPulse Dosing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have been diagnosed with chronic, intractable pain of the back pain with or without leg pain
- Have been implanted with the Nevro Senza™ or Omnia SCS system with dual leads, approximately over vertebral T8-T11, for at least 3 months, and are using the system with single area, continuous 10 kHz stimulation programs at least 18 hours daily, as determined by subject reporting and confirmation via device diagnostics, for at least 21 days prior to enrolling in this study
- If taking them, be on stable chronic pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in the study and be willing to stay on those medications with no dose adjustments until study completion or study withdrawal, whichever comes first.
- Be 18 years of age or older at the time of enrollment
- Be willing and able to comply with study-related requirements, procedures, and visits
Key exclusion criteria (16 listed)
- Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as
- Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome.
- Have a current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumor, central deafferentation syndrome, Complex Regional Pain Syndrome, or acute herniating disc, as determined by the investigator.
- Having any clinical evidence mechanical instability or progressive neurologic pathology that warrants surgical intervention.
- Having undergone an interventional procedure and/or surgery to treat back or leg pain other than Senza HF10 therapy in the last 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCS Device Program SettingAlso: Pulse Dose SettingA Pulse Dose setting specifies a brief duration of stimulation 'on' and stimulation 'off' durations, applied in a continuously cycled manner | Device | Single arm |
Primary outcome
Preference for Pulse Dose Setting
Time frame: 3 months
Starting from a standardized low pulse dose (PD) setting, subjects will try progressively lower PD settings depending upon their response to each setting, to arrive at the lowest PD setting they prefer. Up to 5 PD settings will be tried by each subject.
7 secondary outcomes
Numerical Rating Scale of Back, Leg, and Overall Pain Intensity
Time frame: 3 months
Patient Satisfaction
Time frame: 3 months
Patient Global Impression of Change
Time frame: 3 months
Oswestry Disability Index
Time frame: 3 months
Patient Catastrophizing Scale
Time frame: 3 months
PROMIS-SF Sleep Disturbance Scale
Time frame: 3 months
Daily device recharge duration
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mayank Gupta, MD principal investigator
Neuroscience Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SCS Device Program Setting in people with Chronic, Intractable Back Pain and/or Leg Pain, run by Nevro Corp at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preference for Pulse Dose Setting (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.