Pain, IntractableNCT02503787

OPTIONS Spinal Cord Stimulation Programming Parameters

A study testing Spinal Cord Stimulation (SCS) in people with Pain, Intractable, run by MedtronicNeuro at 11 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

The purpose of this study is to evaluate programming options in spinal cord stimulation for the management of chronic, intractable pain of the trunk and limbs. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, Intractable
What is being tested?: Spinal Cord Stimulation (SCS)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 11 sitesUnited States
Study dates: Jul 2015to Aug 2016
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Candidate for Spinal Cord Stimulation (SCS) system (trial and implant) per labeled indication(back and leg pain)
Willing and able to provide a signed and dated informed consent
At least 18 years old at the time of informed consent
Willing and able to attend visits and comply with the study protocol
Capable of using the patient programmer and recharging the neurostimulator
Willing to not increase pain medications from baseline through the 3-Month Visit

Who cannot join

Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound study results.
Psychological or other health conditions that would interfere with the subject's ability to fulfill the requirements of the protocol.
Trialed or implanted with SCS, subcutaneous stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system
Implanted with a cardiac device (e.g., pacemaker, defibrillator)

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

St. Luke's Neurosurgical Associates
Bethlehem, Pennsylvania, 18018
Millennium Pain Center
Bloomington, Illinois, 61701
Synovation Medical Group
Chula Vista, California, 91914
University Hospitals Case Medical Center
Cleveland, Ohio, 44106-1716
Valley Pain Consultants-North Scottsdale
Scottsdale, Arizona, 85254
Swedish Pain Services
Seattle, Washington, 98122
Northwest Pain Care
Spokane, Washington, 99201
Pain Care LLC
Stockbridge, Georgia, 30281
Precision Spine Care
Tyler, Texas, 75701-4262
Center for Interventional Pain Spine
Wilmington, Delaware, 19803
The Center for Clinical Research
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Prospective, Multi-center, Open-label Study of Programming Options in Spinal Cord Stimulation.

The purpose of this study is to evaluate programming options in spinal cord stimulation for the management of chronic, intractable pain of the trunk and limbs.

Read the detailed description

Prospective, multi-center, open-label study evaluating programming options in spinal cord stimulation on pain relief. All eligible subjects will undergo a Spinal Cord Stimulation (SCS) device trial that includes an intraoperative programming trial. Subjects experiencing a positive response to the programming parameters (improvement in average overall pain relief) during the trial from baseline will move forward with a permanent implant. Those not reporting a positive response to the programming parameters will be exited from the study.

The subjects will complete a number of assessment worksheets to characterize their Quality of Life and function and the level of pain they are experiencing from the baseline to 3 months post neurostimulation trial.

Conditions: Pain, Intractable
Being tested: Spinal Cord Stimulation (SCS)
Keywords: chronic pain, intractable pain, failed back surgery syndrome
Medical subject headings: Pain, Intractable, Chronic Pain, Failed Back Surgery Syndrome

What participants receive

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

Spinal Cord Stimulation (SCS)Device
SCS programming options

Study groups in NCT02503787
Study group	Role	What they receive
Open label treatment	Other	Spinal Cord Stimulation (SCS) Receives: Device: Spinal Cord Stimulation (SCS)

What is being measured

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

Change in Average Overall Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire
Self reported daily average overall pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be).
Measured: From baseline to 3 months post device activation

Secondary outcomes (1)

Patient Global Impression of Change
Evaluate study subject impression of change as measured by the Patient Global Impression of Change questionnaire. The questionnaire encompasses change in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS, and OVERALL QUALITY OF LIFE, scored on a scale of 1-7 (1=no change or the condition has gotten worse: 7=A great deal better, and a considerable improvement that has made all the difference).
Measured: From baseline to 3 months post device activation

Timeline

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

Jul 2015Aug 2016

First posted21 Jul 2015 (estimated)
Study startJul 2015
Primary completionAug 2016
Study completionAug 2016

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.
Other trials for Pain, IntractableStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02503787
Sponsor's protocol ID: 1675
Status last verified: Aug 2017
First submitted: 14 Jul 2015
Last updated: 19 Sep 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-center, Open-label Study of Programming Options in Spinal Cord Stimulation.
ClinicalTrials.gov ID: NCT02503787
Acronym / sponsor ID: 1675
Conditions: Pain, Intractable
Keywords: chronic pain, intractable pain, failed back surgery syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: MedtronicNeuroIndustry (pharma, biotech, devices)
Study start: Jul 2015
Primary completion: Aug 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 21 Jul 2015 (estimated)
Results: Posted 19 Sep 2017

Clinical summary

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

The purpose of this study is to evaluate programming options in spinal cord stimulation for the management of chronic, intractable pain of the trunk and limbs.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Open label treatment	Other	Device: Spinal Cord Stimulation (SCS)Spinal Cord Stimulation (SCS)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Candidate for Spinal Cord Stimulation (SCS) system (trial and implant) per labeled indication(back and leg pain)
Willing and able to provide a signed and dated informed consent
At least 18 years old at the time of informed consent
Willing and able to attend visits and comply with the study protocol
Capable of using the patient programmer and recharging the neurostimulator

Key exclusion criteria (4 listed)

Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound study results.
Psychological or other health conditions that would interfere with the subject's ability to fulfill the requirements of the protocol.
Trialed or implanted with SCS, subcutaneous stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system
Implanted with a cardiac device (e.g., pacemaker, defibrillator)

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
Spinal Cord Stimulation (SCS)SCS programming options	Device	Open label treatment

Primary outcome

Change in Average Overall Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire
Time frame: From baseline to 3 months post device activation
Self reported daily average overall pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be).

1 secondary outcome

Patient Global Impression of Change
Time frame: From baseline to 3 months post device activation

Results and safety

Results posted to the registry on 19 Sep 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Open Label Treatment	64	44

Primary outcome: Change in Average Overall Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire

Time frame: From baseline to 3 months post device activation. Mean (Standard Deviation). Unit: units on a scale

Measure	Open Label Treatment n = 32
Value	-3.7 (2.3)

Open Label Treatment: p <0.01, t-test, 2 sided

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected beginning at the device trialing procedure and throughout implant and the 3 month activation phase.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Device: Neurostimulator	1 of 48 (2.1%)	12 of 48 (25%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Pain, Intractable

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Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain
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RecruitingPhase 1
Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer
Intractable Pain, Palliative Care
RecruitingObservational study
Dexmedetomidine for Refractory Pain in Palliative Cancer Patients
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Not yet recruiting
Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
Refractory Visceral Pelvic Pain, Refractory Genital Pain
Active, not recruitingObservational study
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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.

OPTIONS Clinical Research Study Team study director

Medtronic Implantable Therapies

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

Questions about this trial

What is this clinical trial studying?

A study testing Spinal Cord Stimulation (SCS) in people with Pain, Intractable, run by MedtronicNeuro at 11 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 6 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 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 19 Sep 2017). 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 Average Overall Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire (time frame: From baseline to 3 months post device 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 NCT02503787.

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 19 Sep 2017.