Chronic Pain SyndromeSMENCT01778426

Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy (French SCS Registry)

An observational study of Chronic Pain Syndrome, run by MedtronicNeuro at 1 site in France.

Completed

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

Trial summary

Observational study to evaluate the long term efficacy of Spinal Cord Stimulation (SCS) over 2 years following SCS implant. This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement for SCS in approved indication in France. Read more about this study

Who is it for?: Any age
Conditions the study is for: Chronic Pain Syndrome
How many people: 414 participants
Where: 1 siteFrance
Study dates: Jan 2012to Jun 2016
How long will I take part?: 2 Years
Phase: Observational
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: All patients implanted (first implant or replacements) with a Medtronic neurostimulator in selected French sites .

Who may be able to join

Patient indicated for Spinal Cord Stimulation (pain therapy)
Patient implanted for less than 3 months or hospitalized for the implant of a Medtronic neurostimulator including:
primary implant with Spinal Cord Stimulation indication and positive test of stimulation or
device replacement of a Medtronic neurostimulator used for Pain Therapy
Evaluation of usual pain in the back, upper and lower limbs using a visual analogic scale must be available for the 3 days preceding implant.
Treatments must also be available
Patient read and signed the data release form

Who cannot join

Patient declined participation
Patient is not available for follow up
Stimulation of other body part than spinal

Trial locations and contacts

1 site in 1 country.

France1 site

Hôpital Foch - 40 rue Worth
Suresnes, 92151

Other trials in France

About this study

Official title: Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy

Observational study to evaluate the long term efficacy of Spinal Cord Stimulation (SCS) over 2 years following SCS implant.

This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement for SCS in approved indication in France.

Conditions: Chronic Pain Syndrome
Keywords: Chronic neuropathic pain syndrome, Spinal Cord Stimulation, Painstim devices, Efficacy, Safety

What participants receive

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

Study groups in NCT01778426
Study group	Role	What they receive
Patients with Medtronic neurostimulator		Patients suffering from chronic neuropathic pain syndrome implanted (first implant or replacements) with a Medtronic neurostimulator.

What is being measured

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

Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 2 Years
Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with predominant pain intensity from baseline to two years follow-up. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible).
Measured: 2 years

Secondary outcomes (6)

Percentage of Subjects With at Least 50% Pain Relief in the Area of Non-predominant Pain
Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with non-predominant pain intensity at 1 and 2 years follow-up, compared to baseline. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible).
Measured: 1 year and 2 years
Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 1 Year
Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with predominant pain intensity from baseline to one year follow-up. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible).
Measured: 1 year
Concomitant Pain Relief Medication
Percentage of primo-implanted subjects taking pain relief medication at baseline, 1 and 2 years.
Measured: Baseline, 1 and 2 years
Dose of Analgesics Level 3 (Morphinics)
Dose of analgesics level 3 (morphinics) summarized as equivalent morphine dose at baseline, 1 and 2 years.
Measured: Baseline, 1 and 2 years
Patient Satisfaction
Percentage of primo-implanted subjects satisfied with the treatment 1 and 2 years after implantation (defined as indicating "pain relief improvement," "daily life improvement," "rather satisfied with the treatment," or "would agree to the treatment again").
Measured: 1 and 2 years
Return to Work
Percentage of subjects being invalid at inclusion and active at 1 and 2 years.
Measured: 1 and 2 years

Timeline

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

Jan 2012Jun 2016

First posted29 Jan 2013 (estimated)
Study startJan 2012
Primary completionJun 2016
Study completionJun 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 Chronic Pain SyndromeStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 414 participants (actual)
Target duration: 2 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT01778426
Sponsor's protocol ID: 1051
Acronym: SME
Status last verified: May 2018
First submitted: 24 Jan 2013
Last updated: 29 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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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All Chronic Pain Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy
ClinicalTrials.gov ID: NCT01778426
Acronym / sponsor ID: SME / 1051
Conditions: Chronic Pain Syndrome
Keywords: Chronic neuropathic pain syndrome, Spinal Cord Stimulation, Painstim devices, Efficacy, Safety
Study type: Observational
Recruitment status: Completed
Enrolment: 414 participants (actual)
Lead sponsor: MedtronicNeuroIndustry (pharma, biotech, devices)
Collaborators: Medtronic Cardiac Rhythm and Heart Failure
Study start: Jan 2012
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 29 Jan 2013 (estimated)
Results: Posted 29 Nov 2018

Clinical summary

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

Observational study to evaluate the long term efficacy of Spinal Cord Stimulation (SCS) over 2 years following SCS implant.

This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement for SCS in approved indication in France.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 2 Years
Number of arms: 1

Arm	Type	Receives
Patients with Medtronic neurostimulator	–	–Patients suffering from chronic neuropathic pain syndrome implanted (first implant or replacements) with a Medtronic neurostimulator.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: All patients implanted (first implant or replacements) with a Medtronic neurostimulator in selected French sites .

Key inclusion criteria (7 listed)

Patient indicated for Spinal Cord Stimulation (pain therapy)
Patient implanted for less than 3 months or hospitalized for the implant of a Medtronic neurostimulator including:
primary implant with Spinal Cord Stimulation indication and positive test of stimulation or
device replacement of a Medtronic neurostimulator used for Pain Therapy
Evaluation of usual pain in the back, upper and lower limbs using a visual analogic scale must be available for the 3 days preceding implant.

Key exclusion criteria (3 listed)

Patient declined participation
Patient is not available for follow up
Stimulation of other body part than spinal

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 2 Years
Time frame: 2 years
Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with predominant pain intensity from baseline to two years follow-up. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible).

6 secondary outcomes

Percentage of Subjects With at Least 50% Pain Relief in the Area of Non-predominant Pain
Time frame: 1 year and 2 years
Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 1 Year
Time frame: 1 year
Concomitant Pain Relief Medication
Time frame: Baseline, 1 and 2 years
Dose of Analgesics Level 3 (Morphinics)
Time frame: Baseline, 1 and 2 years
Patient Satisfaction
Time frame: 1 and 2 years
Return to Work
Time frame: 1 and 2 years

Results and safety

Results posted to the registry on 29 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Primo-implant (PI)	264	208
Replacement (RP)	138	113

Primary outcome: Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 2 Years

Time frame: 2 years. Number (95% Confidence Interval). Unit: Percentage of responders

Measure	Primo-implant (PI) n = 198
Value	59.1 (51.9 to 66.0)

Population analysed: ITT - completer (n=198) consists of all primo-implant subjects with baseline and follow-up pain intensity data at 2 years completed. Among 198 subjects, 179 patients had a visit at one year completed.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from enrollment through the study end.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Full Analysis Set (FAS)	89 of 402 (22.1%)	105 of 402 (26.1%)	Not reported

Limitations and caveats (from the sponsor): The targeted pain area of the therapy was assumed to be the one with the predominant NPRS score at baseline. For the replacement group it was unknown if the therapy was active at the time of the device replacement (enrollment).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Pain Syndrome

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Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
RecruitingObservational study
Pain Phenotype and Response to Corticosteroid Injection in Patients With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
Recruiting
Evaluation of the Short-term Effectiveness of Spinal Manipulation to Treat Acute and Subacute Low Back Pain.
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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.

Marie-Christine DJIAN, MD study chair

Hôpital Saint Anne, Paris

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

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Pain Syndrome, run by MedtronicNeuro at 1 site in France.

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 7 inclusion and 3 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 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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 29 Nov 2018). 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?

Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 2 Years (time frame: 2 years). 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 NCT01778426.

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 29 Nov 2018.