Chronic PainSOLISNCT04676022

SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery

A study testing WaveWriter and Conventional Medical Managament in people with Chronic Pain, run by Boston Scientific Corporation at 23 sites in United States.

Completed

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

Official record

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Trial summary

To evaluate the safety and effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities compared to Conventional Medical Management (CMM) in patients with chronic low back and/or leg pain who have not undergone spinal surgery when using the Boston Scientific WaveWriter SCS Systems. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Chronic Pain
What is being tested?: WaveWriter and Conventional Medical Managament
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 241 participants
Where: 23 sitesUnited States
Study dates: 26 Mar 2021to 21 Feb 2025
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 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Chronic low back pain, with or without leg pain, for at least 6 months
Received at least 90 days of documented pain management care to address the primary pain complaint, prior to Screening (e.g. medication, physical therapy)
If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test at Screening
Subject signed a valid, IRB-approved informed consent form (ICF) provided in English

Who cannot join

Primary pain complaint of vascular origin (e.g. peripheral vascular disease)
Require implantation of lead(s) in the cervical epidural space
Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to assess pain intensity
Previous failed spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

United States23 sites

Goodman Campbell Brain and Spine
Carmel, Indiana, 46032
Saint Louis Pain Consultants
Chesterfield, Missouri, 63017
University of Chicago Hospital
Chicago, Illinois, 60637
South Lake Pain Institute, Inc
Clermont, Florida, 34711
Institute of Precision Pain Medicine
Corpus Christi, Texas, 78414
Pacific Sports and Spine, LLC
Eugene, Oregon, 97401
PCPMG Clinical Research Unit, LLC
Greenville, South Carolina, 29601
Denver Back Pain Specialists
Greenwood Village, Colorado, 80111
Carolinas Research Institute, PLLC
Huntersville, North Carolina, 28078
MedPharmics, LLC
Metairie, Louisiana, 70006
Ochsner Clinic Foundation
New Orleans, Louisiana, 70115
Weill Cornell Medical University
New York, New York, 10022
Crimson Pain Management
Overland Park, Kansas, 66210
Vitamed Research
Palm Desert, California, 92260
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84132
Summit Pain Alliance
Santa Rosa, California, 95401
Willis-Knighton River Cities Clinical Research Center
Shreveport, Louisiana, 71105
The Toledo Clinic
Toledo, Ohio, 43623
Delaware Valley Pain and Spine Institute
Trevose, Pennsylvania, 19053
Precision Spine Care
Tyler, Texas, 75701
Novant Health-Hawthorne
Winston-Salem, North Carolina, 27103
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
Forest Health Medical Center
Ypsilanti, Michigan, 48198

Other trials in United States

About this study

Official title: A Randomized Controlled Study to Evaluate the Safety and Effectiveness of Boston Scientific Spinal Cord Stimulation (SCS) Systems in the Treatment of Chronic Low Back and/or Leg Pain With No Prior Surgeries

Conditions: Chronic Pain
Being tested: WaveWriter, Conventional Medical Managament
Keywords: Spinal Cord Stimulation
Medical subject headings: Chronic Pain

What participants receive

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

WaveWriterDevice
To receive Spinal Cord Stimulation programming
Conventional Medical ManagamentOther
To receive conventional medical management

Study groups in NCT04676022
Study group	Role	What they receive
Spinal Cord Stimulation	Experimental	To receive Spinal Cord Stimulation programming Receives: Device: WaveWriter
Conventional Medical Management	Other	To receive conventional medical management Receives: Other: Conventional Medical Managament

What is being measured

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

Responder Rate
Proportion of subjects with 50% or greater reduction in overall pain relief
Measured: 3 months post-activation

Secondary outcomes (1)

Change in Disability (Oswestry Disability Index)
Change in Disability (Oswestry Disability Index). The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The published minimally clinically important difference for change in ODI is 10 points.
Measured: 3-Months post activation

Timeline

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

26 Mar 202121 Feb 2025

First posted19 Dec 2020
Study start26 Mar 2021
Primary completion25 Aug 2022
Study completion21 Feb 2025

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 PainStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
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: 241 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04676022
Sponsor's protocol ID: A4077
Acronym: SOLIS
Status last verified: Feb 2025
First submitted: 15 Dec 2020
Last updated: 6 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

North J, Calodney A, Trainor D, McCormick ZL, Paez J, Loudermilk E, Christopher A, Noles J, Phillips G, Jolly S, Yang MI, Guirguis M, Kloster D, Pak DJ, Peacock J, Engle M, Shah B, Wilson D, Anitescu M, Atallah J, Chatas J, Leier T, Rosen S, Goldberg E. Spinal cord stimulation plus conventional medical management versus conventional medical management alone for severe, non-surgical, refractory back pain: a randomized clinical trial followed by crossover. Reg Anesth Pain Med. 2025 Oct 5:rapm-2024-106335. doi: 10.1136/rapm-2024-106335. Online ahead of print.
PubMed 41047246
O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
PubMed 34854473

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?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Study to Evaluate the Safety and Effectiveness of Boston Scientific Spinal Cord Stimulation (SCS) Systems in the Treatment of Chronic Low Back and/or Leg Pain With No Prior Surgeries
ClinicalTrials.gov ID: NCT04676022
Acronym / sponsor ID: SOLIS / A4077
Conditions: Chronic Pain
Keywords: Spinal Cord Stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 241 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 26 Mar 2021 (actual)
Primary completion: 25 Aug 2022 (actual)
Study completion: 21 Feb 2025 (actual)
First posted: 19 Dec 2020 (actual)
Results: Posted 8 May 2024

Clinical summary

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

Study design

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

Arm	Type	Receives
Spinal Cord Stimulation	Experimental	Device: WaveWriterTo receive Spinal Cord Stimulation programming
Conventional Medical Management	Other	Other: Conventional Medical ManagamentTo receive conventional medical management

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Chronic low back pain, with or without leg pain, for at least 6 months
Received at least 90 days of documented pain management care to address the primary pain complaint, prior to Screening (e.g. medication, physical therapy)
If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test at Screening
Subject signed a valid, IRB-approved informed consent form (ICF) provided in English

Key exclusion criteria (4 listed)

Primary pain complaint of vascular origin (e.g. peripheral vascular disease)
Require implantation of lead(s) in the cervical epidural space
Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to assess pain intensity
Previous failed spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)

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
WaveWriterTo receive Spinal Cord Stimulation programming	Device	Spinal Cord Stimulation
Conventional Medical ManagamentTo receive conventional medical management	Other	Conventional Medical Management

Primary outcome

Responder Rate
Time frame: 3 months post-activation
Proportion of subjects with 50% or greater reduction in overall pain relief

1 secondary outcome

Change in Disability (Oswestry Disability Index)
Time frame: 3-Months post activation

Results and safety

Results posted to the registry on 8 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spinal Cord Stimulation	79	57
Conventional Medical Management	68	64
Non-randomized Subjects	94	0

Primary outcome: Responder Rate

Time frame: 3 months post-activation. Count of participants. Unit: Participants

Measure	Spinal Cord Stimulation n = 57	Conventional Medical Management n = 62
Value	51	5

Population analysed: Intent to Treat population

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Randomized subjects through 3-Months post-Activation, an average of 6 months.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Randomized to SCS	8 of 79 (10.1%)	9 of 79 (11.4%)	0 of 79
Randomized to CMM	1 of 68 (1.5%)	4 of 68 (5.9%)	1 of 68

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41047246North J, Calodney A, Trainor D, McCormick ZL, Paez J, Loudermilk E, Christopher A, Noles J, Phillips G, Jolly S, Yang MI, Guirguis M, Kloster D, Pak DJ, Peacock J, Engle M, Shah B, Wilson D, Anitescu M, Atallah J, Chatas J, Leier T, Rosen S, Goldberg E. Spinal cord stimulation plus conventional medical management versus conventional medical management alone for severe, non-surgical, refractory back pain: a randomized clinical trial followed by crossover. Reg Anesth Pain Med. 2025 Oct 5:rapm-2024-106335. doi: 10.1136/rapm-2024-106335. Online ahead of print.
Derived from this study: PubMed 34854473O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.

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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.

Natalie Bloom Lyons study director

Boston Scientific Corporation

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

Questions about this trial

What is this clinical trial studying?

A study testing WaveWriter and Conventional Medical Managament in people with Chronic Pain, run by Boston Scientific Corporation at 23 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 4 inclusion and 4 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 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 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 8 May 2024). 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?

Responder Rate (time frame: 3 months post-activation). 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 NCT04676022, 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 6 Mar 2025.