Chronic Pain
Conditions
Keywords
spinal cord stimulation, dorsal root ganglion stimulation
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.
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.
Interventions
Subjects will be implanted with market-released Abbott SCS systems
DEVICEDorsal root ganglion stimulation (DRG)
Subjects will be implanted with market-released Abbott DRG system
Sponsors
Abbott Medical Devices
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of device and procedure related adverse events, deaths, and device deficiencies | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS) | 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. |
| Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Catastrophizing Scale (PCS) | 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. |
| Mean Change in Clinical improvement from baseline to each follow up visit assessed by Oswestry Disability Index (ODI) | 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. |
| Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29 | 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. |
| Mean Change in Clinical improvement from baseline to each follow up visit assessed by Transcutaneous Oxygen pressure measurement (TcPO2) | 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. |
| Rate of patient satisfaction | 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. |
| Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient. | 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. |
| Mean Change in Clinical improvement from baseline to each follow up visit assessed by pain condition-related medication usage | 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. |
Countries
Australia, Belgium, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States
Contacts
Primary ContactBram Blomme
Backup ContactSonar Pradhan
Outcome results
None listed