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

• ClinicalTrials.gov Identifier: NCT03876054
• Recruitment Status: Recruiting
• First Posted: March 15, 2019
• Last Update Posted: May 16, 2023
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Chronic Pain	Device: Spinal cord stimulation (SCS); Device: Dorsal root ganglion stimulation (DRG)

Detailed Description:

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 2000 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
• Actual Study Start Date: March 13, 2019
• Estimated Primary Completion Date: June 2029
• Estimated Study Completion Date: December 2029

Groups and Cohorts

Group/Cohort	Intervention/treatment
Spinal cord stimulation (SCS); Subjects using Abbott SCS systems	Device: Spinal cord stimulation (SCS); Subjects will be implanted with market-released Abbott SCS systems
Dorsal root ganglion stimulation (DRG); Subjects using Abbott DRG system	Device: Dorsal root ganglion stimulation (DRG); Subjects will be implanted with market-released Abbott DRG system

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures:

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Sampling Method: Non-Probability Sample

Study 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.

Criteria

Inclusion Criteria:

1. Subject must provide written informed consent prior to any clinical investigation related procedure.
2. 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.
3. Subject is scheduled to have an Abbott neurostimulation system implanted within 60 days of baseline.
4. Subject has a baseline (with no stimulation) pain NRS of ≥ 6.

Exclusion Criteria:

1. Subject is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott.
2. 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.
3. Subject has or is scheduled to receive an intrathecal pump.
4. Subject is part of a vulnerable population.
5. Subject has an existing implanted neuromodulation device to address their chronic pain.

Contacts and Locations

Contacts

Contact: Udoka Okaro; +1 512 286 4258; udoka.okaro@abbott.com

Contact: Jenny Qin; +1 917-349-0779; jenny.qin@abbott.com

Locations

United States, Arizona

Phoenician Centers for Research & Innovation; Active, not recruiting

Phoenix, Arizona, United States, 85021

Pain Institute of Southern Arizona; Recruiting

Tucson, Arizona, United States, 85718

Principal Investigator: Eric Cornidez

United States, California

California Orthopedics & Spine; Completed

Larkspur, California, United States, 94939

Restore Orthopedics & Spine Center; Terminated

Orange, California, United States, 92868

Foothills Pain Management Clinic; Terminated

Pomona, California, United States, 91767

Pacific Research Institute; Recruiting

Santa Rosa, California, United States, 95403

Principal Investigator: Jason Pope

United States, Florida

University of Florida Department of Anesthesia; Recruiting

Gainesville, Florida, United States, 32610

Principal Investigator: Juan Mora

United States, Illinois

Rush University Medical Center; Recruiting

Chicago, Illinois, United States, 60612

Principal Investigator: Timothy Lubenow

University of Chicago; Recruiting

Chicago, Illinois, United States, 60637

Principal Investigator: Magdalena Anitescu

United States, Indiana

Goodman Campbell Brain and Spine; Recruiting

Indianapolis, Indiana, United States, 46032

Principal Investigator: Derron Wilson

United States, Minnesota

Nura; Recruiting

Edina, Minnesota, United States, 55435

Principal Investigator: David Schultz

Twin Cities Pain Clinic; Recruiting

Edina, Minnesota, United States, 55439

Principal Investigator: Andrew Will

Mayo Clinic; Terminated

Rochester, Minnesota, United States, 55905

United States, Missouri

Saint Louis Pain Consultants; Active, not recruiting

Chesterfield, Missouri, United States, 63017

United States, Nevada

Advanced Pain Care; Recruiting

Henderson, Nevada, United States, 89052

Principal Investigator: Michael Fishell

Nevada Advanced Pain Specialists; Recruiting

Reno, Nevada, United States, 89511

Principal Investigator: Denis Patterson

United States, New York

Ainsworth Institute of Pain Management; Recruiting

New York, New York, United States, 10022

Principal Investigator: Corey Hunter

Unity Spine Center; Recruiting

Rochester, New York, United States, 14626

Principal Investigator: Hemant Kalia

The Spine & Pain Institute of New York; Recruiting

Staten Island, New York, United States, 10305

Principal Investigator: Kenneth Chapman

United States, North Carolina

Premier Pain Solutions; Completed

Asheville, North Carolina, United States, 28803

United States, Ohio

Adena Bone and Joint Center; Withdrawn

Chillicothe, Ohio, United States, 45601

Premier Pain Treatment Institute; Withdrawn

Loveland, Ohio, United States, 45140

United States, Oregon

Pacific Sports & Spine; Recruiting

Eugene, Oregon, United States, 97401

Principal Investigator: Gregory Moore

Spinal Diagnostics; Recruiting

Tualatin, Oregon, United States, 97062

Principal Investigator: Robert Heros

United States, Pennsylvania

Center for Interventional Pain & Spine; Recruiting

Exton, Pennsylvania, United States, 19341

Principal Investigator: Michael Fishman

United States, Texas

Expert Pain; Recruiting

Houston, Texas, United States, 77079

Principal Investigator: Ioannis Skaribas

Central Texas Pain Institute; Recruiting

Killeen, Texas, United States, 76542

Principal Investigator: Pankaj Mehta

Integrated Pain Associates; Terminated

Killeen, Texas, United States, 76542

Advanced Pain Care; Recruiting

Round Rock, Texas, United States, 78664

Principal Investigator: Allen Dennis

United States, West Virginia

The Spine & Nerve Center of St Francis Hospital; Recruiting

Charleston, West Virginia, United States, 25301

Principal Investigator: Timothy Deer

Australia, Victoria

Metro Pain Group; Active, not recruiting

Clayton, Victoria, Australia, 3168

Precision Brain, Spine & Pain Centre; Completed

Kew, Victoria, Australia, 3101

Belgium

AZ Nikolaas; Recruiting

Sint-Niklaas, Eflndrs, Belgium, 9100

Principal Investigator: Jean-Pierre Van Buyten

AZ Delta vzw; Recruiting

Roeselare, West Flanders, Belgium, 8800

Principal Investigator: Bart Billet

Germany

Universitäts Klinikum Tübingen; Active, not recruiting

Tubingen, Bad-wur, Germany, 72076

Klinikum Ingolstadt GmbH; Recruiting

Ingolstadt, Bavaria, Germany, 85049

Principal Investigator: Siamak Asgari

Klinikum Duisburg GmbH; Completed

Duisburg, N. Rhin, Germany, 47055

Medizinische Einrichtungen der Universität Düsseldorf; Recruiting

Dusseldorf, N. Rhin, Germany, 40225

Principal Investigator: Jan Vesper

Krankenhaus Neuwerk Maria von den Aposteln; Recruiting

Monchengladbach, N. Rhin, Germany, 41066

Principal Investigator: Bjoern Carsten Schultheis

Kliniken der Stadt Köln-Merheim; Recruiting

Koln, North Rhine-Westphalia, Germany, 51109

Principal Investigator: Faycal El Majdoub

Universitätsklinikum Schleswig-Holstein; Completed

Lübeck, Schleswig-Holstein, Germany, 23538

Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie; Recruiting

Gera, Thuringia, Germany, 07548

Principal Investigator: Michael Kretzschmar

Krankenhaus Porz am Rhein; Recruiting

Koln, Germany, 51149

Principal Investigator: Thomas May

Italy

Azienda Ospedaliera Monaldi; Recruiting

Napoli, Campani, Italy, 80131

Principal Investigator: Alfonso Papa

Fondazione Salvatore Maugeri; Recruiting

Pavia, Lombard, Italy, 27100

Principal Investigator: Laura Demartini

Netherlands

Erasmus MC; Recruiting

Rotterdam, S Holln, Netherlands, 3015

Principal Investigator: F.J.P.M Huygen

St. Antonius Ziekenhuis; Active, not recruiting

Nieuwegein, Utrecht, Netherlands, 3435 CM

Spain

Hospital Universitario de Salamanca; Recruiting

Salamanca, Cstleon, Spain, 37007

Principal Investigator: Francisco Sanchez Montero

Hospital Universitario Puerta de Hierro; Recruiting

Majadahonda, Madrid, Spain, 28222

Principal Investigator: Manuel Herrero

Principal Investigator: Agustin Mendiola

Hospital Universitari i Politècnic La Fe; Recruiting

Valencia, Spain, 46026

Principal Investigator: Ma Angeles Canós Verdecho

Switzerland

Hôpital du Valais; Recruiting

Sion, Valais, Switzerland, 1951

Contact: Lynn Tofor Temsah lynn.toforel-temsah@hopitalvs.ch

Principal Investigator: Claude Haller, MD

United Kingdom

Norfolk and Norwich Hospital; Terminated

Norwich, England, United Kingdom, NR4 7UY

The Walton Centre; Recruiting

Liverpool, North West England, United Kingdom, L9 7LJ

Principal Investigator: Deepti Bhargava

Southmead Hospital; Terminated

Bristol, Sowest, United Kingdom, BS10 5NB

Seacroft Hospital; Recruiting

Leeds, Yorkshire And The Humber, United Kingdom, LS14 6UH

Principal Investigator: Ganesan Baranidharan

Sponsors and Collaborators

Abbott Medical Devices

Investigators

• Study Director: Devyani Nanduri; Abbott Medical Devices Neuromodulation

More Information

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT03876054
• Other Study ID Numbers: ABT-CIP-10279
• First Posted: March 15, 2019
• Last Update Posted: May 16, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Abbott Medical Devices:

spinal cord stimulation; dorsal root ganglion stimulation

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations