Chronic Low-back PainRESTORENCT04803214

ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation

A study testing ReActiv8 in people with Chronic Low-back Pain, run by Mainstay Medical at 28 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM). Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Chronic Low-back Pain
What is being tested?: ReActiv8
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 203 participants
Where: 28 sitesUnited States
Study dates: 14 Jul 2021to 5 Jan 2026
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥21 years
Evidence of lumbar multifidus muscle dysfunction
Intractable Chronic Low Back Pain that has persisted >6 months resulting in pain most of the days in the past 12 months
Failed therapy including pain medications and physical therapy
Not a candidate for spine surgery
Low Back Pain NRS of ≥6 and ≤9

Show all 10Show fewer

Oswestry Disability Index score ≥30 and ≤60
Willing and capable of giving Informed Consent
Able to comply with this protocol
On Optimal Medical Management per the Investigator

Who cannot join

Contraindicated for the ReActiv8 System
BMI > 35
Any surgical correction procedure for scoliosis at any time, or a current clinical diagnosis of moderate to severe scoliosis
An independent MRI assessment identifying a pathology that is likely the cause of the CLBP and is amenable to surgery
Leg pain described as being worse than back pain, or radiculopathy (neuropathic pain) below the knee
Any condition unrelated to CLBP which, in the opinion of the Investigator, could limit physical movement or compliance with the protocol, or interfere with the assessment of efficacy

Show all 10Show fewer

Surgical and other procedure exclusions
Psycho-social exclusions
Protocol compliance exclusions
General exclusions

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

United States28 sites

Augusta Orthopedic & Sports Medicine Specialists
Augusta, Georgia, 30909
University of Colorado
Aurora, Colorado, 80045
Indiana Spine Group
Carmel, Indiana, 46032
OrthoCarolina Sports Medicine Center
Charlotte, North Carolina, 28207
University Hospitals Cleveland
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
Columbia Orthopedic Group
Columbia, Missouri, 65201
Duke University
Durham, North Carolina, 27710
Pacific Sports and Spine
Eugene, Oregon, 97401
Horizon Clinical Research
Fayetteville, Georgia, 30214
Northwell Health
Great Neck, New York, 11021
OrthoIndy
Indianapolis, Indiana, 46278
SSM Health Medical Group
Jefferson City, Missouri, 65109
Freeman Hospital
Joplin, Missouri, 64804
University of Kansas Medical Center
Kansas City, Kansas, 66160
Center for Interventional Pain and Spine
Lancaster, Pennsylvania, 17601
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Ainsworth Institute of Pain Management
New York, New York, 10022
Vista Clinical Research
Newnan, Georgia, 30265
SoCal Sport and Spine
Newport Beach, California, 92660
Barrow Brain & Spine
Phoenix, Arizona, 85013
Cleveland Clinic Martin Health Tradition Hospital
Port Saint Lucie, Florida, 34986
Pacific Research Institute
Santa Rosa, California, 95403
Advent Health Shawnee Mission
Shawnee Mission, Kansas, 66204
Spinal Diagnostics, PC
Tualatin, Oregon, 97062
International Spine, Pain and Performance Center
Washington D.C., District of Columbia, 20006
Cantor Spine Center and Paley Orthopedic Spine Institute
West Palm Beach, Florida, 33407
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM).

Read the detailed description

This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM), where OMM means the patient is managed according to available guideline-directed treatments (e.g., medication, physical therapy, injections) individualized to meet the patient needs. All patients who satisfy the enrollment criteria are randomized (1:1) to receive either ReActiv8 (Treatment group) or OMM (Control group).

Conditions: Chronic Low-back Pain
Being tested: ReActiv8
Keywords: Neurostimulation, Stimulation, Multifidus, Restorative neurostimulation, Multifidus muscle control, Neurostimulator

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ReActiv8Device
Market-approved ReActiv8 device implanted

Study groups in NCT04803214
Study group	Role	What they receive
Treatment (ReActiv8)	Active comparator	Market-approved ReActiv8 device Receives: Device: ReActiv8
Control (OMM)	No intervention	Optimized medical management (OMM) (Standard of Care)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Oswestry Disability Index (ODI)
Comparison of 1-year change from baseline in ODI between Treatment and Control with MMRM for missing data.
ODI is measured on a scale of 0 to 100 where a lower score is a better outcome.
Measured: 1 year

Secondary outcomes (2)

Change in Low Back Pain Numerical Rating Scale (LBP NRS)
Comparison of 1-year change from baseline in LBP NRS between Treatment and Control with MMRM for missing data.
NRS is measured on a scale of 0 to 10 where a higher score is a better outcome.
Measured: 1 year
Change in EQ-5D
Comparison of 1-year change from baseline in EQ-5D between Treatment and Control with MMRM for missing data.
EQ-5D is measured on a scale of -0.5 to 1.0 where a higher score is a better outcome.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jul 20215 Jan 2026

First posted17 Mar 2021
Study start14 Jul 2021
Primary completion4 Sep 2024
Study completion5 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chronic Low-back 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 203 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04803214
Sponsor's protocol ID: 980012
Acronym: RESTORE
Status last verified: Jan 2026
First submitted: 14 Mar 2021
Last updated: 23 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Gilligan C, Burnside D, Grant L, Yong RJ, Mullins PM, Schwab F, Mekhail N. ReActiv8 Stimulation Therapy vs. Optimal Medical Management: A Randomized Controlled Trial for the Treatment of Intractable Mechanical Chronic Low Back Pain (RESTORE Trial Protocol). Pain Ther. 2023 Apr;12(2):607-620. doi: 10.1007/s40122-023-00475-4. Epub 2023 Feb 14.
PubMed 36787013
Schwab F, Mekhail N, Patel KV, Langhorst M, Heros RD, Gentile J, Costandi S, Moore G, Gilmore C, Manion S, Chakravarthy K, Meyer SC, Bundy JV, Tate JL, Sanders R, Vaid S, Szentirmai O, Goree J, Patel VV, Lehmen J, Desai MJ, Pope JE, Giuffrida A, Hayek S, Virk SS, Paicius R, Klemme WR, Levy R, Gilligan C; RESTORE investigators. Restorative Neurostimulation Therapy Compared to Optimal Medical Management: A Randomized Evaluation (RESTORE) for the Treatment of Chronic Mechanical Low Back Pain due to Multifidus Dysfunction. Pain Ther. 2025 Feb;14(1):401-423. doi: 10.1007/s40122-024-00689-0. Epub 2025 Jan 15.
PubMed 39812968

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Low-back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation
ClinicalTrials.gov ID: NCT04803214
Acronym / sponsor ID: RESTORE / 980012
Conditions: Chronic Low-back Pain
Keywords: Neurostimulation, Stimulation, Multifidus, Restorative neurostimulation, Multifidus muscle control, Neurostimulator
Study type: Interventional
Recruitment status: Completed
Enrolment: 203 participants (actual)
Lead sponsor: Mainstay MedicalIndustry (pharma, biotech, devices)
Study start: 14 Jul 2021 (actual)
Primary completion: 4 Sep 2024 (actual)
Study completion: 5 Jan 2026 (actual)
First posted: 17 Mar 2021 (actual)
Results: Posted 13 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment (ReActiv8)	Active comparator	Device: ReActiv8Market-approved ReActiv8 device
Control (OMM)	No intervention	–Optimized medical management (OMM) (Standard of Care)

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Age ≥21 years
Evidence of lumbar multifidus muscle dysfunction
Intractable Chronic Low Back Pain that has persisted >6 months resulting in pain most of the days in the past 12 months
Failed therapy including pain medications and physical therapy
Not a candidate for spine surgery

Key exclusion criteria (10 listed)

Contraindicated for the ReActiv8 System
BMI > 35
Any surgical correction procedure for scoliosis at any time, or a current clinical diagnosis of moderate to severe scoliosis
An independent MRI assessment identifying a pathology that is likely the cause of the CLBP and is amenable to surgery
Leg pain described as being worse than back pain, or radiculopathy (neuropathic pain) below the knee

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
ReActiv8Market-approved ReActiv8 device implanted	Device	Treatment (ReActiv8)

Primary outcome

Change in Oswestry Disability Index (ODI)
Time frame: 1 year
Comparison of 1-year change from baseline in ODI between Treatment and Control with MMRM for missing data. ODI is measured on a scale of 0 to 100 where a lower score is a better outcome.

2 secondary outcomes

Change in Low Back Pain Numerical Rating Scale (LBP NRS)
Time frame: 1 year
Change in EQ-5D
Time frame: 1 year

Results and safety

Results posted to the registry on 13 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment (ReActiv8)	99	94
Control (OMM)	104	94

Primary outcome: Change in Oswestry Disability Index (ODI)

Time frame: 1 year. Mean (Standard Deviation). Unit: units on a scale

Measure	Treatment (ReActiv8) n = 99	Control (OMM) n = 104
Value	-19.7 (1.4)	-2.9 (1.4)

Treatment (ReActiv8) vs Control (OMM): p <0.001, t-test, 2 sided

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment (ReActiv8)	7 of 99 (7.1%)	22 of 99 (22.2%)	0 of 99
Control (OMM)	1 of 104 (1%)	10 of 104 (9.6%)	0 of 104

Limitations and caveats (from the sponsor): Participants were not blinded to their treatment, and as a result, those randomized to the control arm may have experienced a nocebo effect underestimating the clinical effect of OMM. In addition, patients in the treatment arm may have experienced a placebo effect after being randomized to interventional treatment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 36787013Gilligan C, Burnside D, Grant L, Yong RJ, Mullins PM, Schwab F, Mekhail N. ReActiv8 Stimulation Therapy vs. Optimal Medical Management: A Randomized Controlled Trial for the Treatment of Intractable Mechanical Chronic Low Back Pain (RESTORE Trial Protocol). Pain Ther. 2023 Apr;12(2):607-620. doi: 10.1007/s40122-023-00475-4. Epub 2023 Feb 14.
Results publication: PubMed 39812968Schwab F, Mekhail N, Patel KV, Langhorst M, Heros RD, Gentile J, Costandi S, Moore G, Gilmore C, Manion S, Chakravarthy K, Meyer SC, Bundy JV, Tate JL, Sanders R, Vaid S, Szentirmai O, Goree J, Patel VV, Lehmen J, Desai MJ, Pope JE, Giuffrida A, Hayek S, Virk SS, Paicius R, Klemme WR, Levy R, Gilligan C; RESTORE investigators. Restorative Neurostimulation Therapy Compared to Optimal Medical Management: A Randomized Evaluation (RESTORE) for the Treatment of Chronic Mechanical Low Back Pain due to Multifidus Dysfunction. Pain Ther. 2025 Feb;14(1):401-423. doi: 10.1007/s40122-024-00689-0. Epub 2025 Jan 15.
Individual participant dataSharing planned: No

Related trials for Chronic Low-back Pain

Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
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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.

Frank Schwab study chair

New York-Presbyterian

Chris Gilligan study chair

Brigham and Women's Hospital

Kiran Patel study chair

Northwell Health

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ReActiv8 in people with Chronic Low-back Pain, run by Mainstay Medical at 28 sites 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 10 inclusion and 10 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: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Oswestry Disability Index (ODI) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04803214, which also lists 2 linked publications.

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 23 Jan 2026.