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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03876054
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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.

Layout table for study information
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

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




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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876054


Contacts
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Contact: Robyn Capobianco, PhD +1 512 286 4274 robyn.capobianco@abbott.com
Contact: Nicole Harbert +1 972 526 4841 nicole.harbert@abbott.com

Locations
Show Show 51 study locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Robyn Capobianco, PhD Abbott
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03876054    
Other Study ID Numbers: ABT-CIP-10279
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Chronic Pain
Pain
Neurologic Manifestations