CompletedNCT01665040Updated Nov 19, 2020Results posted

Clinical Outcomes Study Using a New Implantable Neurostimulation System for Chronic Intractable Pain

An interventional study of Neurostimulation device implantation in Chronic Pain, sponsored by Boston Scientific Corporation. Completed at 7 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-19.

Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 40
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

The primary objective of this study is to investigate patient satisfaction with treatment using a new implantable neurostimulation system for chronic pain of the trunk and/or limbs.

Conditions studied

Chronic Pain

Browse trials for

Keywords

neurostimulation
spinal cord stimulation
peripheral nerve stimulation

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Chronic intractable pain of the trunk and/or limbs
Documented history of trunk and/or limb pain of at least 180 days
Overall pain intensity of at least 5 on a 0-10 numerical rating scale (OPI-NRS-11) over the past 180 days based on subject recall
Pass study site's routine psychological/psychiatric evaluation within 180 days before signing the informed consent
Subject is willing and able to comply with all protocol-required follow-up evaluations
18 years of age or older when written informed consent is obtained
Subject signs informed consent

Exclusion criteria

Exclusion Criteria:

Unable to operate the Precision Spectra™ System either by self or with a caregiver
Primary source of pain is cancer-related, pelvic, visceral, anginal or migraine
Overall pain intensity of always 10 on a 0-10 numerical rating scale (OPI-NRS-11) over the past 180 days based on subject recall
Is a high surgical risk
Currently on any anticoagulant medications that cannot be discontinued during perioperative period
Subject requires Magnetic Resonance Imaging (MRI) while implanted with lead(s) and/or the Precision Spectra IPG
Subject is participating (or intends to participate) in another investigational drug or device clinical trial that may influence the data that will be collected for this study
Subjects already implanted with an active implantable device(s) to treat their pain (IPGs, implantable drug pumps, etc) or pacemaker or Implantable Cardiac Defibrillator
Patient is a woman who is pregnant (a urine pregnancy test must be performed within 7 days prior to the stimulation trial procedure in women of child-bearing potential) or nursing or intends to become pregnant during the course of the trial.
Failed to achieve satisfactory relief during the stimulation trial phase

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 40 participants (actual)

Study arms

Experimental
Neurostimulation for chronic pain
Neurostimulation (spinal cord stimulation with or without peripheral nerve stimulation of the trunk) for chronic intractable pain of the trunk and/or limbs.
Device: Neurostimulation device implantation

Interventions

DeviceNeurostimulation device implantation
Study subjects will undergo a screening-trial of neurostimulation using the Boston Scientific Corporation Precision Spectra neurostimulation system and may proceed to permanent implantation in the event of a successful screening trial. Treatment will include spinal cord stimulation and may also include peripheral nerve stimulation, based upon the physician's subject-specific treatment plan.

What researchers measure

Primary outcomes

Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG Implantation
Proportion of subjects satisfied with treatment at 90 days post-IPG implantation, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire.
Time frame: 90-days post permanent implantation
Proportion of Subjects Satisfied With Treatment in a Sub-group Utilizing More Than 2 IPG Ports at 365 Days Post-IPG Implantation
Proportion of subjects in a sub-group utilizing more than 2 IPG ports at 365 Days post-IPG implantation satisfied with treatment, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire.
Time frame: 365 days post permanent implantation

Results

Posted Jan 3, 2019

Participant flow

Participant flow — Overall Study
Milestone	Neurostimulation for Chronic Pain
Started	40
Completed	36
Not completed	4

Outcome measures

PrimaryProportion of Subjects Satisfied With Treatment at 90 Days Post-IPG Implantation

Proportion of subjects satisfied with treatment at 90 days post-IPG implantation, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire.

Time frame:: 90-days post permanent implantation
Reported as:: Count of participants · Participants

Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG Implantation
Participants	Neurostimulation for Chronic Pain
Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG Implantation	32

PrimaryProportion of Subjects Satisfied With Treatment in a Sub-group Utilizing More Than 2 IPG Ports at 365 Days Post-IPG Implantation

Proportion of subjects in a sub-group utilizing more than 2 IPG ports at 365 Days post-IPG implantation satisfied with treatment, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire.

Time frame:: 365 days post permanent implantation
Reported as:: Count of participants · Participants

Proportion of Subjects Satisfied With Treatment in a Sub-group Utilizing More Than 2 IPG Ports at 365 Days Post-IPG Implantation
Participants	Neurostimulation for Chronic Pain
Proportion of Subjects Satisfied With Treatment in a Sub-group Utilizing More Than 2 IPG Ports at 365 Days Post-IPG Implantation	21

Adverse events

Collected over 365 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Neurostimulation for Chronic Pain	0/40 (0%)	11/40 (27.5%)	4/40 (10%)

Most frequent serious events

Most frequent serious events
Event	Neurostimulation for Chronic Pain
InfectionInfections and infestations	5/40
Musculoskeletal and Connective Tissue DisordersMusculoskeletal and connective tissue disorders	3/40
Nervous System DisordersNervous system disorders	3/40

Most frequent other events

Most frequent other events
Event	Neurostimulation for Chronic Pain
FallsInjury, poisoning and procedural complications	4/40

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Neurostimulation for Chronic Pain
Mean	53.9 ± 13.6

Sex: Female, Male
Sex: Female, Male(Participants)	Neurostimulation for Chronic Pain
Female	25
Male	15

Study locations

7 sites

Metro Spinal Clinic
Caulfield, Australia
Hunter Clinical Research
Melbourne, Australia
AZ Delta
Roeselare, Belgium
Clinica Universitaria de Navarra
Madrid, Spain
Hospital La Paz
Madrid, Spain
Hospital Universitario Quiron Madrid
Madrid, Spain
H. Clinico Universitario
Valencia, Spain

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01665040
Lead sponsor: Boston Scientific Corporation
Responsible party: Sponsor
First posted: Aug 15, 2012
Start date: Aug 2012
Primary completion: May 2014
Completion: Dec 2014
Results posted: Jan 3, 2019
Last update: Nov 19, 2020

Study contacts

Roshini Jain

study director · Boston Scientific Neuromodulation Corporation

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Chronic Pain→

Other studies from this sponsor

Boston Scientific Corporation

Start the discussion