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

Chronic Pain Clinical Trial

— REALITY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03876054
• Other study ID #: ABT-CIP-10279
• Status: Recruiting
• Start date: March 13, 2019
• Est. completion date: December 2029

Study information

• Verified date: January 2024
• Source: Abbott Medical Devices
• Contact: Udoka Okaro
• Phone: +1 512 286 4258
• Email: udoka.okaro[@]abbott.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2029
• Est. primary completion date: June 2029
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Spinal cord stimulation (SCS)
Subjects will be implanted with market-released Abbott SCS systems
• Dorsal root ganglion stimulation (DRG)
Subjects will be implanted with market-released Abbott DRG system

Locations

Country	Name	City	State
Australia	Metro Pain Group	Clayton	Victoria
Australia	Precision Brain, Spine & Pain Centre	Kew	Victoria
Belgium	AZ Delta vzw	Roeselare	West Flanders
Belgium	AZ Nikolaas	Sint-Niklaas	Eflndrs
Germany	Klinikum Duisburg GmbH	Duisburg	N. Rhin
Germany	Medizinische Einrichtungen der Universität Düsseldorf	Dusseldorf	N. Rhin
Germany	Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie	Gera	Thuringia
Germany	Klinikum Ingolstadt GmbH	Ingolstadt	Bavaria
Germany	Kliniken der Stadt Köln-Merheim	Koln	North Rhine-Westphalia
Germany	Krankenhaus Porz am Rhein	Koln
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck	Schleswig-Holstein
Germany	Krankenhaus Neuwerk Maria von den Aposteln	Monchengladbach	N. Rhin
Germany	Universitäts Klinikum Tübingen	Tubingen	Bad-wur
Italy	Azienda Ospedaliera Monaldi	Napoli	Campani
Italy	Fondazione Salvatore Maugeri	Pavia	Lombard
Netherlands	St. Antonius Ziekenhuis	Nieuwegein	Utrecht
Netherlands	Erasmus MC	Rotterdam	S Holln
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Universitario de Salamanca	Salamanca	Cstleon
Spain	Hospital Universitari i Politècnic La Fe	Valencia
Switzerland	Hôpital du Valais	Sion	Valais
United Kingdom	Southmead Hospital	Bristol	Sowest
United Kingdom	Seacroft Hospital	Leeds	Yorkshire And The Humber
United Kingdom	The Walton Centre	Liverpool	North West England
United Kingdom	Norfolk and Norwich Hospital	Norwich	England
United States	Premier Pain Solutions	Asheville	North Carolina
United States	The Spine & Nerve Center of St Francis Hospital	Charleston	West Virginia
United States	Saint Louis Pain Consultants	Chesterfield	Missouri
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Adena Bone and Joint Center	Chillicothe	Ohio
United States	Nura	Edina	Minnesota
United States	Twin Cities Pain Clinic	Edina	Minnesota
United States	Pacific Sports & Spine	Eugene	Oregon
United States	Center for Interventional Pain & Spine	Exton	Pennsylvania
United States	University of Florida Department of Anesthesia	Gainesville	Florida
United States	Advanced Pain Care	Henderson	Nevada
United States	Expert Pain	Houston	Texas
United States	Goodman Campbell Brain and Spine	Indianapolis	Indiana
United States	Central Texas Pain Institute	Killeen	Texas
United States	Integrated Pain Associates	Killeen	Texas
United States	California Orthopedics & Spine	Larkspur	California
United States	Premier Pain Treatment Institute	Loveland	Ohio
United States	Ainsworth Institute of Pain Management	New York	New York
United States	Restore Orthopedics & Spine Center	Orange	California
United States	Phoenician Centers for Research & Innovation	Phoenix	Arizona
United States	Foothills Pain Management Clinic	Pomona	California
United States	Nevada Advanced Pain Specialists	Reno	Nevada
United States	Mayo Clinic	Rochester	Minnesota
United States	Unity Spine Center	Rochester	New York
United States	Advanced Pain Care	Round Rock	Texas
United States	Pacific Research Institute	Santa Rosa	California
United States	The Spine & Pain Institute of New York	Staten Island	New York
United States	Spinal Diagnostics	Tualatin	Oregon
United States	Pain Institute of Southern Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Germany,  Italy,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29	The PROMIS-29 is used to estimate overall quality of life by assessing the following domains known to impact activities of daily living: physical function, sleep disturbance, depression, anxiety, fatigue, pain interference, pain intensity, and social role satisfaction. The scale requires subjects to rate the frequency and/or severity of symptoms and experiences related to each of these domains. The final item is an 11-point pain intensity numerical rating scale (NRS) by which the subject rates their average pain over the past 7 days. Subjects should read each item and check the one box that most closely represents their response.; This study has no primary or secondary endpoints, all endpoints are of equal weight.	6 months
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29	The PROMIS-29 is used to estimate overall quality of life by assessing the following domains known to impact activities of daily living: physical function, sleep disturbance, depression, anxiety, fatigue, pain interference, pain intensity, and social role satisfaction. The scale requires subjects to rate the frequency and/or severity of symptoms and experiences related to each of these domains. The final item is an 11-point pain intensity numerical rating scale (NRS) by which the subject rates their average pain over the past 7 days. Subjects should read each item and check the one box that most closely represents their response.; This study has no primary or secondary endpoints, all endpoints are of equal weight.	1 Year
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29	The PROMIS-29 is used to estimate overall quality of life by assessing the following domains known to impact activities of daily living: physical function, sleep disturbance, depression, anxiety, fatigue, pain interference, pain intensity, and social role satisfaction. The scale requires subjects to rate the frequency and/or severity of symptoms and experiences related to each of these domains. The final item is an 11-point pain intensity numerical rating scale (NRS) by which the subject rates their average pain over the past 7 days. Subjects should read each item and check the one box that most closely represents their response.; This study has no primary or secondary endpoints, all endpoints are of equal weight.	2 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29	The PROMIS-29 is used to estimate overall quality of life by assessing the following domains known to impact activities of daily living: physical function, sleep disturbance, depression, anxiety, fatigue, pain interference, pain intensity, and social role satisfaction. The scale requires subjects to rate the frequency and/or severity of symptoms and experiences related to each of these domains. The final item is an 11-point pain intensity numerical rating scale (NRS) by which the subject rates their average pain over the past 7 days. Subjects should read each item and check the one box that most closely represents their response.; This study has no primary or secondary endpoints, all endpoints are of equal weight.	3 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29	The PROMIS-29 is used to estimate overall quality of life by assessing the following domains known to impact activities of daily living: physical function, sleep disturbance, depression, anxiety, fatigue, pain interference, pain intensity, and social role satisfaction. The scale requires subjects to rate the frequency and/or severity of symptoms and experiences related to each of these domains. The final item is an 11-point pain intensity numerical rating scale (NRS) by which the subject rates their average pain over the past 7 days. Subjects should read each item and check the one box that most closely represents their response.; This study has no primary or secondary endpoints, all endpoints are of equal weight.	4 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29	The PROMIS-29 is used to estimate overall quality of life by assessing the following domains known to impact activities of daily living: physical function, sleep disturbance, depression, anxiety, fatigue, pain interference, pain intensity, and social role satisfaction. The scale requires subjects to rate the frequency and/or severity of symptoms and experiences related to each of these domains. The final item is an 11-point pain intensity numerical rating scale (NRS) by which the subject rates their average pain over the past 7 days. Subjects should read each item and check the one box that most closely represents their response.; This study has no primary or secondary endpoints, all endpoints are of equal weight.	5 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)	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.	6 months
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)	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 months
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)	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.	1 year
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)	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.	1.5 years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)	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.	2 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)	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.	2.5 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)	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.	3 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)	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.	3.5 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)	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.	4 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)	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.	4.5 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)	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.	5 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Catastrophizing Scale (PCS)	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.	6 months
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Catastrophizing Scale (PCS)	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.	1 Year
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Catastrophizing Scale (PCS)	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.	2 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Catastrophizing Scale (PCS)	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.	3 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Catastrophizing Scale (PCS)	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.	4 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Catastrophizing Scale (PCS)	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.	5 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Oswestry Disability Index (ODI)	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.	6 months
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Oswestry Disability Index (ODI)	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.	1 Year
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Oswestry Disability Index (ODI)	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.	2 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Oswestry Disability Index (ODI)	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.	3 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Oswestry Disability Index (ODI)	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.	4 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Oswestry Disability Index (ODI)	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.	5 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by pain condition-related medication usage	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.	6 months
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by pain condition-related medication usage	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.	1 Year
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by pain condition-related medication usage	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.	2 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by pain condition-related medication usage	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.	3 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by pain condition-related medication usage	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.	4 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by pain condition-related medication usage	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.	5 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Transcutaneous Oxygen pressure measurement (TcPO2)	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.	6 months
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Transcutaneous Oxygen pressure measurement (TcPO2)	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.	1 Year
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Transcutaneous Oxygen pressure measurement (TcPO2)	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.	2 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Transcutaneous Oxygen pressure measurement (TcPO2)	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.	3 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Transcutaneous Oxygen pressure measurement (TcPO2)	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.	4 Years
Other	Mean Change in Clinical improvement from baseline to each follow up visit assessed by Transcutaneous Oxygen pressure measurement (TcPO2)	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.	5 Years
Other	Rate of patient satisfaction	Patient satisfaction will be summarized using counts and percentages; This study has no primary or secondary endpoints, all endpoints are of equal weight.	6 months
Other	Rate of patient satisfaction	Patient satisfaction will be summarized using counts and percentages; This study has no primary or secondary endpoints, all endpoints are of equal weight.	1 Year
Other	Rate of patient satisfaction	Patient satisfaction will be summarized using counts and percentages; This study has no primary or secondary endpoints, all endpoints are of equal weight.	2 Years
Other	Rate of patient satisfaction	Patient satisfaction will be summarized using counts and percentages; This study has no primary or secondary endpoints, all endpoints are of equal weight.	3 Years
Other	Rate of patient satisfaction	Patient satisfaction will be summarized using counts and percentages; This study has no primary or secondary endpoints, all endpoints are of equal weight.	4 Years
Other	Rate of patient satisfaction	Patient satisfaction will be summarized using counts and percentages; This study has no primary or secondary endpoints, all endpoints are of equal weight.	5 Years
Other	Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.	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.	6 months
Other	Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.	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.	9 months
Other	Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.	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.	1 Year
Other	Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.	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.	1.5 Year
Other	Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.	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.	2 Years
Other	Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.	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.	2.5 Years
Other	Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.	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.	3 Years
Other	Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.	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.	3.5 Years
Other	Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.	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.	4 Years
Other	Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.	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.	4.5 Years
Other	Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.	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.	5 Years
Primary	Rate of device and procedure related adverse events, deaths, and device deficiencies	Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates.; This study has no primary or secondary endpoints, all endpoints are of equal weight.	Baseline
Primary	Rate of device and procedure related adverse events, deaths, and device deficiencies	Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates.; This study has no primary or secondary endpoints, all endpoints are of equal weight.	Permanent Implant Procedure
Primary	Rate of device and procedure related adverse events, deaths, and device deficiencies	Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates.; This study has no primary or secondary endpoints, all endpoints are of equal weight.	6 months
Primary	Rate of device and procedure related adverse events, deaths, and device deficiencies	Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and will be summarized using counts, percentages or Kaplan-Meier survival estimates.; This study has no primary or secondary endpoints, all endpoints are of equal weight.	9 months
Primary	Rate of device and procedure related adverse events, deaths, and device deficiencies	Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates.; This study has no primary or secondary endpoints, all endpoints are of equal weight.	1 Year
Primary	Rate of device and procedure related adverse events, deaths, and device deficiencies	Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and will be summarized using counts, percentages or Kaplan-Meier survival estimates.; This study has no primary or secondary endpoints, all endpoints are of equal weight.	1.5 Years
Primary	Rate of device and procedure related adverse events, deaths, and device deficiencies	Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates.; This study has no primary or secondary endpoints, all endpoints are of equal weight.	2 Years
Primary	Rate of device and procedure related adverse events, deaths, and device deficiencies	Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and will be summarized using counts, percentages or Kaplan-Meier survival estimates.; This study has no primary or secondary endpoints, all endpoints are of equal weight.	2.5 Years
Primary	Rate of device and procedure related adverse events, deaths, and device deficiencies	Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates.; This study has no primary or secondary endpoints, all endpoints are of equal weight.	3 Years
Primary	Rate of device and procedure related adverse events, deaths, and device deficiencies	Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and will be summarized using counts, percentages or Kaplan-Meier survival estimates.; This study has no primary or secondary endpoints, all endpoints are of equal weight.	3.5 Years
Primary	Rate of device and procedure related adverse events, deaths, and device deficiencies	Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates.; This study has no primary or secondary endpoints, all endpoints are of equal weight.	4 Years
Primary	Rate of device and procedure related adverse events, deaths, and device deficiencies	Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and will be summarized using counts, percentages or Kaplan-Meier survival estimates.; This study has no primary or secondary endpoints, all endpoints are of equal weight.	4.5 Years
Primary	Rate of device and procedure related adverse events, deaths, and device deficiencies	Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates.; This study has no primary or secondary endpoints, all endpoints are of equal weight.	5 Years