RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain

ConditionPain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoston Scientific Corporation

About this trial

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 Instructions for Use

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

18 years of age or older

Disqualifiers

Contraindicated for Boston Scientific neurostimulation system

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

Trial population

Subjects who exhibit an on-label indication for neurostimulation to relieve chronic intractable pain, according to the Instructions for Use, as applicable in each country or region

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • neurostimulation system

    Device

    Trial stimulation period, followed by permanent implant of a neurostimulation system for subjects with a positive trial outcome

Treatment groups

4,800 Participants
are divided into 1 treatment group
Group A: Boston Scientific SCS Systems1 intervention

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

1

Percent Pain Relief

Percent pain relief of targeted pain at 6, 12, 24, 36, 48, and 60 months follow up

Time frame
Up to 60 months follow up
2

Percent Pain Relief

Percent pain relief of low back pain at 6, 12, 24, 36, 48, and 60 months follow up

Time frame
Up to 60 months follow up
3

Percent Pain Relief

Percent pain relief of leg pain at 6, 12, 24, 36, 48, and 60 months follow up

Time frame
Up to 60 months follow up
4

Change in QoL

Change in quality of life as reported by the Subject at

Time frame
Up to 60 months follow up

Sponsors and contacts

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