Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
ConditionChronic Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbbott Medical Devices
About this trial
The REALITY study is a prospective, post-market, non-randomized, multi-center, single-arm, open-label study intended to collect short- and long-term safety and effectiveness data on various populations implanted with Abbott's neurostimulation systems.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject must provide written informed consent prior to any clinical investigation related procedure.
Subject is at least 18 years (or the minimum age required by local law to consent for participation in a clinical investigation) or older at the time of enrollment.
Subject is scheduled to have an Abbott neurostimulation system implanted within 60 days of baseline.
Subject has a baseline (with no stimulation) pain NRS of ≥ 6.
Disqualifiers
Subject is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott.
Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements.
Subject has or is scheduled to receive an intrathecal pump.
Subject is part of a vulnerable population.
Trial population
This clinical investigation will enroll adult male and female individuals scheduled to have an Abbott neurostimulation system implanted. Subjects must meet all eligibility criteria and provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Spinal cord stimulation (SCS)
DeviceSubjects will be implanted with market-released Abbott SCS systems
Dorsal root ganglion stimulation (DRG)
DeviceSubjects will be implanted with market-released Abbott DRG system
Treatment groups
2,000 Participants
are divided into 2 treatment groupsGroup A: Spinal cord stimulation (SCS)1 intervention
Group B: Dorsal root ganglion stimulation (DRG)1 intervention
Trial outcomes
Primary outcomes
1
Rate of device and procedure related adverse events, deaths, and device deficiencies
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame
Baseline2
Rate of device and procedure related adverse events, deaths, and device deficiencies
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame
Permanent Implant Procedure3
Rate of device and procedure related adverse events, deaths, and device deficiencies
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame
6 months4
Rate of device and procedure related adverse events, deaths, and device deficiencies
Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame
9 monthsOther outcomes
1
Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29
The PROMIS-29 is used to estimate overall quality of life by assessing the following domains known to impact activities of daily living: physical function, sleep disturbance, depression, anxiety, fatigue, pain interference, pain intensity, and social role satisfaction. The scale requires subjects to rate the frequency and/or severity of symptoms and experiences related to each of these domains. The final item is an 11-point pain intensity numerical rating scale (NRS) by which the subject rates their average pain over the past 7 days. Subjects should read each item and check the one box that most closely represents their response. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame
6 months2
Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29
The PROMIS-29 is used to estimate overall quality of life by assessing the following domains known to impact activities of daily living: physical function, sleep disturbance, depression, anxiety, fatigue, pain interference, pain intensity, and social role satisfaction. The scale requires subjects to rate the frequency and/or severity of symptoms and experiences related to each of these domains. The final item is an 11-point pain intensity numerical rating scale (NRS) by which the subject rates their average pain over the past 7 days. Subjects should read each item and check the one box that most closely represents their response. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame
1 Year3
Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29
The PROMIS-29 is used to estimate overall quality of life by assessing the following domains known to impact activities of daily living: physical function, sleep disturbance, depression, anxiety, fatigue, pain interference, pain intensity, and social role satisfaction. The scale requires subjects to rate the frequency and/or severity of symptoms and experiences related to each of these domains. The final item is an 11-point pain intensity numerical rating scale (NRS) by which the subject rates their average pain over the past 7 days. Subjects should read each item and check the one box that most closely represents their response. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame
2 Years4
Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29
The PROMIS-29 is used to estimate overall quality of life by assessing the following domains known to impact activities of daily living: physical function, sleep disturbance, depression, anxiety, fatigue, pain interference, pain intensity, and social role satisfaction. The scale requires subjects to rate the frequency and/or severity of symptoms and experiences related to each of these domains. The final item is an 11-point pain intensity numerical rating scale (NRS) by which the subject rates their average pain over the past 7 days. Subjects should read each item and check the one box that most closely represents their response. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time frame
3 YearsSponsors and contacts
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Source ClinicalTrials.gov