Chronic PainCOMBONCT03689920

Combining Mechanisms for Better Outcomes (COMBO)

A study testing Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System in people with Chronic Pain and Back Pain, run by Boston Scientific Corporation at 15 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

To evaluate the effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities as compared to conventional SCS in patients with chronic pain when using the Boston Scientific Spectra WaveWriter SCS System. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Chronic Pain, Back Pain
What is being tested?: Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 174 participants
Where: 15 sitesUnited States
Study dates: 3 Oct 2018to 15 Dec 2021
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 pain of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain.
22 years of age or older at time of enrollment
Able to independently read and complete all questionnaires and assessments provided in English
Signed a valid, IRB-approved informed consent form (ICF) provided in English

Who cannot join

Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes
Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
Breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception
Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

South Lake Pain Institute, Inc
Clermont, Florida, 34711
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Pacific Sports and Spine, LLC
Eugene, Oregon, 97401
Michigan Pain Consultants
Grand Rapids, Michigan, 49546
Denver Back Pain Specialists
Greenwood Village, Colorado, 80111
Carolinas Research Institute, LLC
Huntersville, North Carolina, 28078
EvergreenHealth Pain Care
Kirkland, Washington, 98034
UCSD Medical Center - Jacobs Medical Center
La Jolla, California, 92037
KC Pain Centers
Lee's Summit, Missouri, 64086
Center for Pain and Supportive Care
Phoenix, Arizona, 85028
Willis-Knighton River Cities Clinical Research Center
Shreveport, Louisiana, 71105
Toledo Clinic
Toledo, Ohio, 43623
Precision Spine Care
Tyler, Texas, 75701
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103
Forest Health Medical Center
Ypsilanti, Michigan, 48198

Other trials in United States

About this study

Official title: Study to Demonstrate the Value of Multiple Modalities and Combining Mechanisms Using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain

Read the detailed description

Conditions: Chronic Pain, Back Pain
Being tested: Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System
Medical subject headings: Chronic Pain, Back Pain

What participants receive

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

Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) SystemDevice
The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.

Study groups in NCT03689920
Study group	Role	What they receive
WaveWriter Settings	Active comparator	WaveWriter Programming Receives: Device: Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System
Conventional Settings	Active comparator	Conventional Programming Receives: Device: Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System

What is being measured

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

Overall Pain Responder Rate
Percentage of subjects with 50% or greater reduction from Baseline Visit in average overall pain intensity at 3 months post-randomization with no increase in opioid medications
Measured: 3 months post-randomization

Timeline

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

3 Oct 201815 Dec 2021

First posted1 Oct 2018
Study start3 Oct 2018
Primary completion5 Nov 2019
Study completion15 Dec 2021

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 (1)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: 174 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03689920
Sponsor's protocol ID: A4070
Acronym: COMBO
Status last verified: Dec 2021
First submitted: 27 Sep 2018
Last updated: 11 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Wallace MS, North JM, Phillips GM, Calodney AK, Scowcroft JA, Popat-Lewis BU, Lee JM, Washabaugh EP 3rd, Paez J, Bolash RB, Noles J, Atallah J, Shah B, Ahadian FM, Trainor DM, Chen L, Jain R. Combination therapy with simultaneous delivery of spinal cord stimulation modalities: COMBO randomized controlled trial. Pain Manag. 2023 Mar;13(3):171-184. doi: 10.2217/pmt-2022-0101. Epub 2023 Mar 3.
PubMed 36866658

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

Recruiting
The Intervention Effect of Exercise on Lumbar Multifidus Muscle Injuries
Chronic Non-specific Low Back Pain, Lumbar Multifidus Muscle Injury
Not yet recruiting
Acceptance and Commitment Therapy Plus Physiotherapy for Chronic Low Back Pain
Low Back Pain
Not yet recruiting
Erector Spinae Plane Block With or Without Thoracolumbar Fascia Injection for Chronic Low Back Pain
Chronic Low Back Pain
Recruiting
Healing Track Clinical Trial
Chronic Back Pain
Active, not recruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain

All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study to Demonstrate the Value of Multiple Modalities and Combining Mechanisms Using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain
ClinicalTrials.gov ID: NCT03689920
Acronym / sponsor ID: COMBO / A4070
Conditions: Chronic Pain, Back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 174 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 3 Oct 2018 (actual)
Primary completion: 5 Nov 2019 (actual)
Study completion: 15 Dec 2021 (actual)
First posted: 1 Oct 2018 (actual)
Results: Posted 27 Nov 2020

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
WaveWriter Settings	Active comparator	Device: Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) SystemWaveWriter Programming
Conventional Settings	Active comparator	Device: Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) SystemConventional Programming

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 pain of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain.
22 years of age or older at time of enrollment
Able to independently read and complete all questionnaires and assessments provided in English
Signed a valid, IRB-approved informed consent form (ICF) provided in English

Key exclusion criteria (4 listed)

Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes
Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
Breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception
Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study

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
Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) SystemThe Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.	Device	Conventional Settings, WaveWriter Settings

Primary outcome

Overall Pain Responder Rate
Time frame: 3 months post-randomization
Percentage of subjects with 50% or greater reduction from Baseline Visit in average overall pain intensity at 3 months post-randomization with no increase in opioid medications

Results and safety

Results posted to the registry on 27 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
WaveWriter Settings	47	41
Conventional Settings	52	48

Primary outcome: Overall Pain Responder Rate

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

Measure	WaveWriter Settings n = 41	Conventional Settings n = 48
Value	36	34

Adverse events

Time frame: Adverse Events were collected up to end of randomized phase (3 months post-randomization). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
WaveWriter Settings	4 of 41 (9.8%)	0 of 41 (0%)	0 of 41
Conventional Settings	5 of 48 (10.4%)	0 of 48 (0%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36866658Wallace MS, North JM, Phillips GM, Calodney AK, Scowcroft JA, Popat-Lewis BU, Lee JM, Washabaugh EP 3rd, Paez J, Bolash RB, Noles J, Atallah J, Shah B, Ahadian FM, Trainor DM, Chen L, Jain R. Combination therapy with simultaneous delivery of spinal cord stimulation modalities: COMBO randomized controlled trial. Pain Manag. 2023 Mar;13(3):171-184. doi: 10.2217/pmt-2022-0101. Epub 2023 Mar 3.
Individual participant dataSharing planned: No

Related trials for Chronic Pain

Recruiting
The Intervention Effect of Exercise on Lumbar Multifidus Muscle Injuries
Chronic Non-specific Low Back Pain, Lumbar Multifidus Muscle Injury
Not yet recruiting
Acceptance and Commitment Therapy Plus Physiotherapy for Chronic Low Back Pain
Low Back Pain
Not yet recruiting
Erector Spinae Plane Block With or Without Thoracolumbar Fascia Injection for Chronic Low Back Pain
Chronic Low Back Pain
Recruiting
Healing Track Clinical Trial
Chronic Back Pain
Active, not recruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain

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.

Mark Wallace, M.D. principal investigator

University of California, San Diego

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

Questions about this trial

What is this clinical trial studying?

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 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 27 Nov 2020). 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?

Overall Pain Responder Rate (time frame: 3 months post-randomization). 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 NCT03689920, which also lists 1 linked publication.

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 11 Jan 2022.