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History of Changes for Study: NCT01719055
RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain (RELIEF)
Latest version (submitted November 8, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 31, 2012 None (earliest Version on record)
2 November 29, 2012 Recruitment Status, Study Status and Contacts/Locations
3 May 3, 2013 Contacts/Locations, Study Status, Eligibility and Study Identification
4 June 10, 2013 Study Status and Contacts/Locations
5 August 12, 2013 Study Status
6 September 30, 2013 Study Status and Contacts/Locations
7 November 12, 2013 Contacts/Locations and Study Status
8 October 8, 2014 Study Status and Study Identification
9 July 21, 2015 Study Status and Contacts/Locations
10 December 3, 2015 Study Status
11 July 1, 2016 Study Status
12 September 18, 2017 Study Status
13 October 5, 2018 Study Status
14 December 6, 2018 Study Status
15 January 10, 2019 Study Status
16 September 9, 2019 Study Status
17 October 23, 2019 Outcome Measures, Groups and Interventions and Study Status
18 April 29, 2020 Study Status and Contacts/Locations
19 August 17, 2020 Contacts/Locations and Study Status
20 November 17, 2020 Contacts/Locations and Study Status
21 December 10, 2020 Study Status and Contacts/Locations
22 March 2, 2021 Contacts/Locations and Study Status
23 April 9, 2021 Contacts/Locations and Study Status
24 May 3, 2021 Contacts/Locations and Study Status
25 May 27, 2021 Contacts/Locations and Study Status
26 June 3, 2021 Contacts/Locations and Study Status
27 September 8, 2021 Contacts/Locations and Study Status
28 October 4, 2021 Contacts/Locations and Study Status
29 November 8, 2021 Contacts/Locations and Study Status
30 December 8, 2021 Contacts/Locations and Study Status
31 December 28, 2021 Contacts/Locations and Study Status
32 February 2, 2022 Study Status
33 March 2, 2022 Contacts/Locations and Study Status
34 April 12, 2022 Study Status and Contacts/Locations
35 May 2, 2022 Study Status
36 June 3, 2022 Study Status
37 June 15, 2022 Contacts/Locations and Study Status
38 July 12, 2022 Study Status
39 August 2, 2022 Study Status
40 September 8, 2022 Study Status
41 September 15, 2022 Contacts/Locations and Study Status
42 September 27, 2022 Contacts/Locations and Study Status
43 November 8, 2022 Study Status and Contacts/Locations
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Study NCT01719055
Submitted Date:  October 31, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: A7007
Brief Title: RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain (RELIEF)
Official Title: A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2012
Overall Status: Not yet recruiting
Study Start: November 2012
Primary Completion: January 2015 [Anticipated]
Study Completion: July 2017 [Anticipated]
First Submitted: October 30, 2012
First Submitted that
Met QC Criteria:
October 31, 2012
First Posted: November 1, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 31, 2012
Last Update Posted: November 1, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Boston Scientific Corporation
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary:

To compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice, when used according to the applicable Directions for Use

- and -

To evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice

Detailed Description:

The study is a prospective, multi-center, global registry of Boston Scientific neurostimulation systems for pain.

The study treatment will consist of neurostimulation trial therapy with any commercially approved Boston Scientific Corporation neurostimulator for pain. Positive trials, subjects with a successful trial outcome, may progress to permanent implant of a neurostimulation system. Individualization of neurostimulation therapy for pain will be determined according to investigator discretion and site routine care, and in accordance with inclusion and exclusion criteria.

Open or close this module Conditions
Conditions: Pain
Keywords: stimulation
implantable
pulse generator
back pain
chronic pain
leg pain
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 4800 [Anticipated]
Number of Groups/Cohorts 2
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Precision Plus
Subjects permanently implanted with a Boston Scientific Precision Plus neurostimulation system
Device: neurostimulation system
Trial stimulation period, followed by permanent implant of a neurostimulation system for subjects with a positive trial outcome
Alternative Boston Scientific systems
Subjects permanently implanted with other Boston Scientific neurostimulation systems
Device: neurostimulation system
Trial stimulation period, followed by permanent implant of a neurostimulation system for subjects with a positive trial outcome
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Percent pain relief
[ Time Frame: 6 months ]

Subject-reported percent pain relief of targeted pain at 6 months post neurostimulation trial
Secondary Outcome Measures:
1. Percent pain relief
[ Time Frame: End of Neurostimulation Trial, 12, 24, and 36 months post neurostimulation trial ]

Percent pain relief of targeted pain as reported by the Subject
2. Change in pain intensity
[ Time Frame: from Baseline to End of Neurostimulation Trial, 6, 12, 24, and 36 months post neurostimulation trial ]

Change in intensity of targeted pain as reported by the Subject
3. Change in physical functioning
[ Time Frame: from Baseline to 6, 12, 24, and 36 months post neurostimulation trial ]

Change in physical functioning as reported by the Subject
4. Change in QoL
[ Time Frame: from Baseline to 6, 12, 24, and 36 months post neurostimulation trial ]

Change in quality of life as reported by the Subject
5. Global impression
[ Time Frame: 6, 12, 24, and 36 months post neurostimulation trial ]

Clinical global impression as reported by the physician
6. Subject global impression
[ Time Frame: 6, 12, 24, and 36 months post neurostimulation trial ]

Subject global impression as reported by the Subject
7. Depression
[ Time Frame: from Baseline to 12 and 36 months post neurostimulation trial ]

Change in depression as reported by the Subject
8. Paresthesia Coverage
[ Time Frame: End of neurostimulation trial, IPG implantation, 6, 12, 24, and 36 months post neurostimulation trial ]

Paresthesia coverage of targeted pain (a tingling sensation associated with neurostimulation therapy) as reported by the Subject
9. Medications
[ Time Frame: from Baseline to 6, 12, 24, and 36 months post neurostimulation trial ]

Change in the total amount of physician-prescribed, pain-related medications used
10. Subject Satisfaction
[ Time Frame: at End of neurostimulation trial, IPG implantation, 6, 12, 24, and 36 months post neurostimulation trial ]

Satisfaction with treatment as reported by the Subject
11. Trial to Permanent Implantation
[ Time Frame: 12 months ]

Progression to permanent implantation with a Boston Scientific neurostimulation system by 12 months post neurostimulation trial
12. Ease of Use
[ Time Frame: 6 months ]

Patient ease of use of the implanted system, as reported by the Subject
Other Outcome Measures:
1. Work Productivity
[ Time Frame: from Baseline to 6, 12, 24, and 36 months post neurostimulation trial ]

Change in employment as reported by the Subject
2. Resource Utilization
[ Time Frame: from Baseline to 6, 12, 24, and 36 months post neurostimulation trial ]

Change in medical resource utilization
3. Adverse Events
[ Time Frame: 36 months ]

Rate of device-related and procedure-related Adverse Events (AEs) from trial lead insertion through completion of study
4. Serious Adverse Events
[ Time Frame: 36 months ]

Rate of Serious Adverse Events (SAEs) from informed consent through completion of study
Open or close this module Eligibility
Study Population: Subjects who exhibit an on-label indication for neurostimulation to relieve chronic intractable pain, according to the Directions for Use, as applicable in each country or region
Sampling Method: Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

CI1. Study candidate is scheduled to be trialed, on-label, with a commercially approved Boston Scientific neurostimulation system for pain, per local directions for use (DFU)

CI2. Signed a valid, IRB/EC-approved informed consent form

CI3. 18 years of age or older when written informed consent is obtained

Exclusion Criteria:

CE1. Meets any contraindication in BSC neurostimulation system local DFU

CE2. Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments

Open or close this module Contacts/Locations
Central Contact Person: Lyn M Pimentel, MBA
Telephone: (661) 949-4174
Central Contact Backup: Nic Van Dyck
Telephone: +31 43 356 8328
Study Officials: Kay Adair
Study Director
Boston Scientific Corporation
Locations: United States, California
Metorpolitan Pain Management Consultants
Sacramento, California, United States, 95821
Contact:Contact: Lee T Snook, MD 916-568-8338
Contact:Principal Investigator: Lee T Snook, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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