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NCT Number: NCT03876054

Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Metro Pain Group, Clayton, Victoria, Australia

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About this study

This study has broad inclusion criteria and minimal exclusion criteria to ensure the results are representative of the real-world use of these devices. Enrollment caps will be implemented to ensure patients from approved indications are represented. Individuals who are scheduled to receive an implantable Abbott neurostimulation system are eligible for study consideration. The study will enroll up to 2,000 subjects from up to 100 participating centers. Subject enrollment is expected to be completed within 7 years; subjects will be followed for 5 years. The total duration of the study is expected to be 13 years, including enrollment, data collection from all subjects, and study close out.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Subject has an existing implanted neuromodulation device to address their chronic pain.

Treatment and study plan

Spinal cord stimulation (SCS)

Device

Subjects will be implanted with market-released Abbott SCS systems

Dorsal root ganglion stimulation (DRG)

Device

Subjects will be implanted with market-released Abbott DRG system

Primary outcomes

  1. Rate of device and procedure related adverse events, deaths, and device deficiencies

    Time frame: Baseline

    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.

  2. Rate of device and procedure related adverse events, deaths, and device deficiencies

    Time frame: Permanent Implant Procedure

    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.

  3. Rate of device and procedure related adverse events, deaths, and device deficiencies

    Time frame: 6 months

    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.

  4. Rate of device and procedure related adverse events, deaths, and device deficiencies

    Time frame: 9 months

    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.

  5. Rate of device and procedure related adverse events, deaths, and device deficiencies

    Time frame: 1 Year

    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.

  6. Rate of device and procedure related adverse events, deaths, and device deficiencies

    Time frame: 1.5 Years

    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.

  7. Rate of device and procedure related adverse events, deaths, and device deficiencies

    Time frame: 2 Years

    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.

  8. Rate of device and procedure related adverse events, deaths, and device deficiencies

    Time frame: 2.5 Years

    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.

  9. Rate of device and procedure related adverse events, deaths, and device deficiencies

    Time frame: 3 Years

    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.

  10. Rate of device and procedure related adverse events, deaths, and device deficiencies

    Time frame: 3.5 Years

    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.

  11. Rate of device and procedure related adverse events, deaths, and device deficiencies

    Time frame: 4 Years

    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.

  12. Rate of device and procedure related adverse events, deaths, and device deficiencies

    Time frame: 4.5 Years

    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.

  13. Rate of device and procedure related adverse events, deaths, and device deficiencies

    Time frame: 5 Years

    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.

Other outcomes

  1. Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29

    Time frame: 6 months

    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.

  2. Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29

    Time frame: 1 Year

    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.

  3. Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29

    Time frame: 2 Years

    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.

  4. Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29

    Time frame: 3 Years

    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.

  5. Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29

    Time frame: 4 Years

    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.

  6. Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29

    Time frame: 5 Years

    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.

  7. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)

    Time frame: 6 months

    The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their pain at the time of study visit specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  8. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)

    Time frame: 9 months

    The pain NRS consists of 1 question that will be asked to the subjects via telephone calls. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their pain at the time of study visit specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  9. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)

    Time frame: 1 year

    The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their pain at the time of study visit specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  10. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)

    Time frame: 1.5 years

    The pain NRS consists of 1 question that will be asked to the subjects via telephone calls. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their pain at the time of study visit specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  11. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)

    Time frame: 2 Years

    The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their pain at the time of study visit specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  12. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)

    Time frame: 2.5 Years

    The pain NRS consists of 1 question that will be asked to the subjects via telephone calls. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their pain at the time of study visit specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  13. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)

    Time frame: 3 Years

    The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their pain at the time of study visit specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  14. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)

    Time frame: 3.5 Years

    The pain NRS consists of 1 question that will be asked to the subjects via telephone calls. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their pain at the time of study visit specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  15. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)

    Time frame: 4 Years

    The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their pain at the time of study visit specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  16. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)

    Time frame: 4.5 Years

    The pain NRS consists of 1 question that will be asked to the subjects via telephone calls. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their pain at the time of study visit specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  17. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)

    Time frame: 5 Years

    The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their pain at the time of study visit specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  18. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Catastrophizing Scale (PCS)

    Time frame: 6 months

    Pain Catastrophizing Scale is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain). Subjects answer questions about how they feel and what they think about when they are in pain (i.e., not at the current moment). The scale includes 13 statements concerning pain experiences that are rated on a scale between 0 'not at all' and 4 'all the time'. The scale is self-administered and takes 5 minutes to complete. A higher score indicates a higher level of catastrophizing.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  19. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Catastrophizing Scale (PCS)

    Time frame: 1 Year

    Pain Catastrophizing Scale is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain). Subjects answer questions about how they feel and what they think about when they are in pain (i.e., not at the current moment). The scale includes 13 statements concerning pain experiences that are rated on a scale between 0 'not at all' and 4 'all the time'. The scale is self-administered and takes 5 minutes to complete. A higher score indicates a higher level of catastrophizing.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  20. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Catastrophizing Scale (PCS)

    Time frame: 2 Years

    Pain Catastrophizing Scale is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain). Subjects answer questions about how they feel and what they think about when they are in pain (i.e., not at the current moment). The scale includes 13 statements concerning pain experiences that are rated on a scale between 0 'not at all' and 4 'all the time'. The scale is self-administered and takes 5 minutes to complete. A higher score indicates a higher level of catastrophizing.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  21. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Catastrophizing Scale (PCS)

    Time frame: 3 Years

    Pain Catastrophizing Scale is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain). Subjects answer questions about how they feel and what they think about when they are in pain (i.e., not at the current moment). The scale includes 13 statements concerning pain experiences that are rated on a scale between 0 'not at all' and 4 'all the time'. The scale is self-administered and takes 5 minutes to complete. A higher score indicates a higher level of catastrophizing.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  22. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Catastrophizing Scale (PCS)

    Time frame: 4 Years

    Pain Catastrophizing Scale is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain). Subjects answer questions about how they feel and what they think about when they are in pain (i.e., not at the current moment). The scale includes 13 statements concerning pain experiences that are rated on a scale between 0 'not at all' and 4 'all the time'. The scale is self-administered and takes 5 minutes to complete. A higher score indicates a higher level of catastrophizing.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  23. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Catastrophizing Scale (PCS)

    Time frame: 5 Years

    Pain Catastrophizing Scale is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain). Subjects answer questions about how they feel and what they think about when they are in pain (i.e., not at the current moment). The scale includes 13 statements concerning pain experiences that are rated on a scale between 0 'not at all' and 4 'all the time'. The scale is self-administered and takes 5 minutes to complete. A higher score indicates a higher level of catastrophizing.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  24. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Oswestry Disability Index (ODI)

    Time frame: 6 months

    The ODI is a 10-item scale that evaluates disability related to low-back and leg pain. It is widely used, validated, and has been translated into several languages. Each section in the scale covers a different domain (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling). Each item is scored on a scale from 0-5 with the first item scored a "0" and representing no disability. The final item is scored a "5" and represents the maximum level of disability. If more than one response in a section is checked, the highest score is chosen. The scores for each section are summed for a final score ranging from 0 to 50. If an item is not answered, the total score is instead calculated as a percentage of the total possible score for all items that were completed.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  25. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Oswestry Disability Index (ODI)

    Time frame: 1 Year

    The ODI is a 10-item scale that evaluates disability related to low-back and leg pain. It is widely used, validated, and has been translated into several languages. Each section in the scale covers a different domain (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling). Each item is scored on a scale from 0-5 with the first item scored a "0" and representing no disability. The final item is scored a "5" and represents the maximum level of disability. If more than one response in a section is checked, the highest score is chosen. The scores for each section are summed for a final score ranging from 0 to 50. If an item is not answered, the total score is instead calculated as a percentage of the total possible score for all items that were completed.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  26. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Oswestry Disability Index (ODI)

    Time frame: 2 Years

    The ODI is a 10-item scale that evaluates disability related to low-back and leg pain. It is widely used, validated, and has been translated into several languages. Each section in the scale covers a different domain (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling). Each item is scored on a scale from 0-5 with the first item scored a "0" and representing no disability. The final item is scored a "5" and represents the maximum level of disability. If more than one response in a section is checked, the highest score is chosen. The scores for each section are summed for a final score ranging from 0 to 50. If an item is not answered, the total score is instead calculated as a percentage of the total possible score for all items that were completed.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  27. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Oswestry Disability Index (ODI)

    Time frame: 3 Years

    The ODI is a 10-item scale that evaluates disability related to low-back and leg pain. It is widely used, validated, and has been translated into several languages. Each section in the scale covers a different domain (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling). Each item is scored on a scale from 0-5 with the first item scored a "0" and representing no disability. The final item is scored a "5" and represents the maximum level of disability. If more than one response in a section is checked, the highest score is chosen. The scores for each section are summed for a final score ranging from 0 to 50. If an item is not answered, the total score is instead calculated as a percentage of the total possible score for all items that were completed.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  28. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Oswestry Disability Index (ODI)

    Time frame: 4 Years

    The ODI is a 10-item scale that evaluates disability related to low-back and leg pain. It is widely used, validated, and has been translated into several languages. Each section in the scale covers a different domain (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling). Each item is scored on a scale from 0-5 with the first item scored a "0" and representing no disability. The final item is scored a "5" and represents the maximum level of disability. If more than one response in a section is checked, the highest score is chosen. The scores for each section are summed for a final score ranging from 0 to 50. If an item is not answered, the total score is instead calculated as a percentage of the total possible score for all items that were completed.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  29. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Oswestry Disability Index (ODI)

    Time frame: 5 Years

    The ODI is a 10-item scale that evaluates disability related to low-back and leg pain. It is widely used, validated, and has been translated into several languages. Each section in the scale covers a different domain (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling). Each item is scored on a scale from 0-5 with the first item scored a "0" and representing no disability. The final item is scored a "5" and represents the maximum level of disability. If more than one response in a section is checked, the highest score is chosen. The scores for each section are summed for a final score ranging from 0 to 50. If an item is not answered, the total score is instead calculated as a percentage of the total possible score for all items that were completed.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  30. Mean Change in Clinical improvement from baseline to each follow up visit assessed by pain condition-related medication usage

    Time frame: 6 months

    Pain condition-related medication usage (e.g. opioids, anti-convulsants, anti-depressants, sleep aids, topicals) will be summarized using mean, standard deviation, median, minimum, maximum, and a 95% confidence interval.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  31. Mean Change in Clinical improvement from baseline to each follow up visit assessed by pain condition-related medication usage

    Time frame: 1 Year

    Pain condition-related medication usage (e.g. opioids, anti-convulsants, anti-depressants, sleep aids, topicals) will be summarized using mean, standard deviation, median, minimum, maximum, and a 95% confidence interval.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  32. Mean Change in Clinical improvement from baseline to each follow up visit assessed by pain condition-related medication usage

    Time frame: 2 Years

    Pain condition-related medication usage (e.g. opioids, anti-convulsants, anti-depressants, sleep aids, topicals) will be summarized using mean, standard deviation, median, minimum, maximum, and a 95% confidence interval.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  33. Mean Change in Clinical improvement from baseline to each follow up visit assessed by pain condition-related medication usage

    Time frame: 3 Years

    Pain condition-related medication usage (e.g. opioids, anti-convulsants, anti-depressants, sleep aids, topicals) will be summarized using mean, standard deviation, median, minimum, maximum, and a 95% confidence interval.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  34. Mean Change in Clinical improvement from baseline to each follow up visit assessed by pain condition-related medication usage

    Time frame: 4 Years

    Pain condition-related medication usage (e.g. opioids, anti-convulsants, anti-depressants, sleep aids, topicals) will be summarized using mean, standard deviation, median, minimum, maximum, and a 95% confidence interval.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  35. Mean Change in Clinical improvement from baseline to each follow up visit assessed by pain condition-related medication usage

    Time frame: 5 Years

    Pain condition-related medication usage (e.g. opioids, anti-convulsants, anti-depressants, sleep aids, topicals) will be summarized using mean, standard deviation, median, minimum, maximum, and a 95% confidence interval.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  36. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Transcutaneous Oxygen pressure measurement (TcPO2)

    Time frame: 6 months

    Transcutaneous Oxygen pressure measurement (TcPO2) will be summarized using mean, standard deviation, median, minimum, maximum, and a 95% confidence interval.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  37. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Transcutaneous Oxygen pressure measurement (TcPO2)

    Time frame: 1 Year

    Transcutaneous Oxygen pressure measurement (TcPO2) will be summarized using mean, standard deviation, median, minimum, maximum, and a 95% confidence interval.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  38. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Transcutaneous Oxygen pressure measurement (TcPO2)

    Time frame: 2 Years

    Transcutaneous Oxygen pressure measurement (TcPO2) will be summarized using mean, standard deviation, median, minimum, maximum, and a 95% confidence interval.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  39. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Transcutaneous Oxygen pressure measurement (TcPO2)

    Time frame: 3 Years

    Transcutaneous Oxygen pressure measurement (TcPO2) will be summarized using mean, standard deviation, median, minimum, maximum, and a 95% confidence interval.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  40. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Transcutaneous Oxygen pressure measurement (TcPO2)

    Time frame: 4 Years

    Transcutaneous Oxygen pressure measurement (TcPO2) will be summarized using mean, standard deviation, median, minimum, maximum, and a 95% confidence interval.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  41. Mean Change in Clinical improvement from baseline to each follow up visit assessed by Transcutaneous Oxygen pressure measurement (TcPO2)

    Time frame: 5 Years

    Transcutaneous Oxygen pressure measurement (TcPO2) will be summarized using mean, standard deviation, median, minimum, maximum, and a 95% confidence interval.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  42. Rate of patient satisfaction

    Time frame: 6 months

    Patient satisfaction will be summarized using counts and percentages

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  43. Rate of patient satisfaction

    Time frame: 1 Year

    Patient satisfaction will be summarized using counts and percentages

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  44. Rate of patient satisfaction

    Time frame: 2 Years

    Patient satisfaction will be summarized using counts and percentages

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  45. Rate of patient satisfaction

    Time frame: 3 Years

    Patient satisfaction will be summarized using counts and percentages

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  46. Rate of patient satisfaction

    Time frame: 4 Years

    Patient satisfaction will be summarized using counts and percentages

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  47. Rate of patient satisfaction

    Time frame: 5 Years

    Patient satisfaction will be summarized using counts and percentages

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  48. Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.

    Time frame: 6 months

    The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject will be requested to rate their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via an interview technique. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderatly better, 6-better, and 7-a great deal better

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  49. Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.

    Time frame: 9 months

    The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject will be requested to rate their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via telephone calls. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderatly better, 6-better, and 7-a great deal better

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  50. Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.

    Time frame: 1 Year

    The PGIC is a categorical rating scale used to evaluate the subject'simpression of change in his/her condition since the beginning of thestudy treatment. The subject will be requested to rate their overallchange in activity limitations, symptoms, emotions and overall qualityof life related to his/her condition on a seven-point categorical scale via an interview technique. The categories are as follows: 1-nochange, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderatly better, 6-better, and 7-a great deal better.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  51. Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.

    Time frame: 1.5 Year

    The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject will be requested to rate their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via telephone calls. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderatly better, 6-better, and 7-a great deal better

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  52. Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.

    Time frame: 2 Years

    The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject will be requested to rate their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via an interview technique. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderatly better, 6-better, and 7-a great deal better.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  53. Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.

    Time frame: 2.5 Years

    The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject will be requested to rate their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via telephone calls. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderatly better, 6-better, and 7-a great deal better

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  54. Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.

    Time frame: 3 Years

    The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject will be requested to rate their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via an interview technique. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderatly better, 6-better, and 7-a great deal better.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  55. Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.

    Time frame: 3.5 Years

    The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject will be requested to rate their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via telephone calls. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderatly better, 6-better, and 7-a great deal better

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  56. Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.

    Time frame: 4 Years

    The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject will be requested to rate their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via an interview technique. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderatly better, 6-better, and 7-a great deal better.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  57. Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.

    Time frame: 4.5 Years

    The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject will be requested to rate their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via telephone calls. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderatly better, 6-better, and 7-a great deal better

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  58. Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.

    Time frame: 5 Years

    The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject will be requested to rate their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via an interview technique. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderatly better, 6-better, and 7-a great deal better.

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

Study contacts

Contact information is provided by the study sponsor or research team.

Bram Blomme

CONTACT

[email protected]

+32 474 74 83 10

Sonar Pradhan

CONTACT

[email protected]

+1 818-282-6456

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: REALITY

Important dates

Study start
2019
Primary completion
2029
Study completion
2029
First posted
Mar 15, 2019
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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