Chronic PainWHISPERNCT02314000

Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude

A study testing Precision or Precision Spectra Spinal Cord Stimulator System in people with Chronic Pain, run by Boston Scientific Corporation at 26 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 demonstrate sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at sub-perception amplitude 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?: Precision or Precision Spectra Spinal Cord Stimulator System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 229 participants
Where: 26 sitesUnited States
Study dates: Dec 2014to 7 Aug 2018
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

Complaint of chronic pain of the trunk and/or limbs
Willing and able to comply with all protocol-required procedures and assessments/evaluations; able to independently read and complete all questionnaires and assessments provided in English
Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) provided in English

Who cannot join

Meets any contraindication in the Precision SCS system per locally applicable Directions for Use (DFU)
Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

Vidant Roanoke - Chowan Hospital Pain Center
Ahoskie, North Carolina, 27910
Shepherd Center
Atlanta, Georgia, 30309
Coastal Pain & Spinal Diagnostics
Carlsbad, California, 92009
University of Cincinnati Physicians Company
Cincinnati, Ohio, 45219
Clearwater Pain Management
Clearwater, Florida, 33756
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Western Reserve Hospital
Cuyahoga Falls, Ohio, 44223
Geisinger Medical Center
Danville, Pennsylvania, 17822
Florence Neurosurgery and Spine
Florence, South Carolina, 29506
PCPMG Clinical Research Unit, LLC
Greenville, South Carolina, 29621
Jackson Anesthesia Pain Center, LLC
Jackson, Mississippi, 39202
KC Pain Centers
Lee's Summit, Missouri, 64086
American Health Network of Indiana, LLC
Muncie, Indiana, 47304
Comprehensive Pain & Rehabilitation
Pascagoula, Mississippi, 39581
MORE Foundation
Phoenix, Arizona, 85023
TBI Clinical Research, L.L.C.
Plano, Texas, 75093
Kaiser Foundation Hospital - Redwood City
Redwood City, California, 94063
University of California, Davis Medical Center
Sacramento, California, 95817
Orthopedic Research Foundation
Savannah, Georgia, 31405
Swedish Medical Center
Seattle, Washington, 98124
Mercy Medical Research Institute
Springfield, Missouri, 65804
Tallahassee Neurological Clinic, PA
Tallahassee, Florida, 32308
University of Toledo Medical Center
Toledo, Ohio, 43614
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: WHISPER - A Randomized Controlled Study to Evaluate the Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude

To demonstrate sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at sub-perception amplitude

Read the detailed description

To demonstrate sustained clinically significant pain relief in patients when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at sub-perception amplitude

Conditions: Chronic Pain
Being tested: Precision or Precision Spectra Spinal Cord Stimulator System
Medical subject headings: Chronic Pain

What participants receive

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

Precision or Precision Spectra Spinal Cord Stimulator SystemDevice

Study groups in NCT02314000
Study group	Role	What they receive
SCS starting with supra-perception	Active comparator	Precision or Precision Spectra Spinal Cord Stimulator System programmed at supra-perception followed by sub-perception SCS Receives: Device: Precision or Precision Spectra Spinal Cord Stimulator System
SCS starting with sub-perception amplitude	Experimental	Precision or Precision Spectra Spinal Cord Stimulator System programmed at sub-perception followed by supra-perception SCS Receives: Device: Precision or Precision Spectra Spinal Cord Stimulator System

What is being measured

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

Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline
Proportion of subjects with 50% or greater reduction in overall pain intensity from baseline with supra and sub perception amplitude with no increase in average daily medication intake to treat pain
Measured: 90 days post activation

Timeline

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

Dec 20147 Aug 2018

First posted10 Dec 2014 (estimated)
Study startDec 2014
Primary completionDec 2016
Study completion7 Aug 2018

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: Crossover
Masking: None (open label)
Enrolment: 229 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02314000
Sponsor's protocol ID: A4046
Other IDs: 90987574
Acronym: WHISPER
Status last verified: Jan 2021
First submitted: 8 Dec 2014
Last updated: 11 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

North J, Loudermilk E, Lee A, Sachdeva H, Kaiafas D, Washabaugh E, Sheth S, Scowcroft J, Mekhail N, Lampert B, Yearwood T, Shaw E, Atallah J, McLeod C, Han J, Yu C, Sedrak M, Lucas R, Trobridge A, Hegarty J, Miller N, Chen L, Jain R. Outcomes of a Multicenter, Prospective, Crossover, Randomized Controlled Trial Evaluating Subperception Spinal Cord Stimulation at </=1.2 kHz in Previously Implanted Subjects. Neuromodulation. 2020 Jan;23(1):102-108. doi: 10.1111/ner.13015. Epub 2019 Jul 2.
PubMed 31265205

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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Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: WHISPER - A Randomized Controlled Study to Evaluate the Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude
ClinicalTrials.gov ID: NCT02314000
Acronym / sponsor ID: WHISPER / A4046
Conditions: Chronic Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 229 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: Dec 2014 (actual)
Primary completion: Dec 2016 (actual)
Study completion: 7 Aug 2018 (actual)
First posted: 10 Dec 2014 (estimated)
Results: Posted 12 Apr 2019

Clinical summary

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

To demonstrate sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at sub-perception amplitude

Detailed description

To demonstrate sustained clinically significant pain relief in patients when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at sub-perception amplitude

Study design

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

Arm	Type	Receives
SCS starting with supra-perception	Active comparator	Device: Precision or Precision Spectra Spinal Cord Stimulator SystemPrecision or Precision Spectra Spinal Cord Stimulator System programmed at supra-perception followed by sub-perception SCS
SCS starting with sub-perception amplitude	Experimental	Device: Precision or Precision Spectra Spinal Cord Stimulator SystemPrecision or Precision Spectra Spinal Cord Stimulator System programmed at sub-perception followed by supra-perception SCS

Who may qualify

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

Key inclusion criteria (3 listed)

Complaint of chronic pain of the trunk and/or limbs
Willing and able to comply with all protocol-required procedures and assessments/evaluations; able to independently read and complete all questionnaires and assessments provided in English
Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) provided in English

Key exclusion criteria (2 listed)

Meets any contraindication in the Precision SCS system per locally applicable Directions for Use (DFU)
Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes

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
Precision or Precision Spectra Spinal Cord Stimulator System	Device	SCS starting with sub-perception amplitude, SCS starting with supra-perception

Primary outcome

Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline
Time frame: 90 days post activation
Proportion of subjects with 50% or greater reduction in overall pain intensity from baseline with supra and sub perception amplitude with no increase in average daily medication intake to treat pain

Results and safety

Results posted to the registry on 12 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SCS Starting With Supra-perception Amplitude	75	62
SCS Starting With Sub-perception Amplitude	65	57

Primary outcome: Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline

Time frame: 90 days post activation. Count of participants. Unit: Participants

Measure	SCS With Supra-perception Amplitude n = 119	SCS With Sub-perception Amplitude n = 118
Value	32	41

Population analysed: Due to the nature of crossover study design, all subjects contributed towards each arm, as reflected in the number of participants.

Adverse events

Time frame: Adverse events up to end of cross over period - approximately upto 180 days after randomization. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Study Patients Through End of Randomized Phase	7 of 140 (5%)	0 of 140 (0%)	0 of 140
SCS With Supra Perception Amplitude	3 of 140 (2.1%)	0 of 140 (0%)	0 of 140
SCS With Subperception Amplitude	4 of 140 (2.9%)	0 of 140 (0%)	0 of 140

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31265205North J, Loudermilk E, Lee A, Sachdeva H, Kaiafas D, Washabaugh E, Sheth S, Scowcroft J, Mekhail N, Lampert B, Yearwood T, Shaw E, Atallah J, McLeod C, Han J, Yu C, Sedrak M, Lucas R, Trobridge A, Hegarty J, Miller N, Chen L, Jain R. Outcomes of a Multicenter, Prospective, Crossover, Randomized Controlled Trial Evaluating Subperception Spinal Cord Stimulation at </=1.2 kHz in Previously Implanted Subjects. Neuromodulation. 2020 Jan;23(1):102-108. doi: 10.1111/ner.13015. Epub 2019 Jul 2.

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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.

Roshini Jain, M.S. study director

Boston Scientific Neuromodulation Corporation

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

Questions about this trial

What is this clinical trial studying?

A study testing Precision or Precision Spectra Spinal Cord Stimulator System in people with Chronic Pain, run by Boston Scientific Corporation at 26 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 3 inclusion and 2 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 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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 12 Apr 2019). 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?

Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline (time frame: 90 days 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 NCT02314000, 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 Feb 2021.