Neurostimulator Clinical Trial
The REALITY study is a post-market, prospective, non-randomized, single-arm, open-label study. It is intended to collect short- and long-term safety and effectiveness data on various populations implanted with Abbott’s neurostimulation systems. 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.
We are honored to be selected as one of only a few clinics around the country in the clinical trial. Our practice and our professional staff were selected due to our leadership and experience in the treatment of chronic pain conditions, and our experience with Neurostimulator implants.
If you are interested to learn more, or to find out if you meet the criteria for this study, complete the form on this page, or call us for more information at 832-862-7246.
Study Details
Primary Outcome Measures:
- Evaluation of device related adverse events [ Time Frame: 5 years ]
Collecting device related adverse events
Other Outcome Measures:
- Clinical improvement from baseline to each follow up visit assessed by using PROMIS-29 [ Time Frame: Baseline, 6-month, 1-, 2-, 3-, 4-, 5-year ]
Patient Reported Outcomes Measurement Information System Adult Profile (PROMIS 29) – assess the overall quality of life
- Clinical improvement from baseline to each follow up visit assessed by Numeric Rating Scale (NRS) for pain intensity, [ Time Frame: Baseline, 6-month, 1-, 2-, 3-, 4-, 5-year ]
Pain reported from 0 “no pain” – 10 “worst imaginable pain”
- Clinical improvement from baseline to each follow up visit assessed by Pain Catastrophizing Scale (PCS) [ Time Frame: Baseline, 6-month, 1-, 2-, 3-, 4-, 5-year ]
A measure of “an exaggerated negative mental set brought to bear during actual or anticipated painful experience.”
- Clinical improvement from baseline to each follow up visit assessed by Oswestry Disability Index (ODI) (optional) [ Time Frame: Baseline, 6-month, 1-, 2-, 3-, 4-, 5-year ]
A scale for measuring back-related physical function. 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. The scores for each section are summed for a final score ranging from 0 to 50. For example: Example: 16 points scored on all 10 items (max 50) equals 32%. However, 16 points scored over 9 items (max 45) equals 35.6%. The final scores are categorized as follows: 0% to 20%: minimal disability, 21%-40%: moderate disability, 41%-60%: severe disability, 61%-80%: crippled, 81%-100%
- Clinical improvement from baseline to each follow up visit assessed by pain condition-related medication usage [ Time Frame: Baseline, 6-month, 1-, 2-, 3-, 4-, 5-year ]
Information about medication usage
- Clinical improvement from baseline to each follow up visit assessed by transcutaneous oxygen pressure measurement (TcPO2) [ Time Frame: Baseline, 6-month, 1-, 2-, 3-, 4-, 5-year ]
TcPO2 is used to measure oxygen level of the tissue below the skin
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Subject must provide written informed consent prior to any clinical investigation related procedure.
- Subject is at least 18 years (or the minimum age required by local law to consent for participation in a clinical investigation) or older at the time of enrollment.
- Subject is scheduled to have an Abbott neurostimulation system implanted within 30 days.
Exclusion Criteria:
- Subject is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator’s opinion, could limit the subject’s ability to participate in the clinical investigation or to comply with follow-up requirements.
- Subject is part of a vulnerable population including incapacitated individuals, individuals unable to read or write, individuals under the age of legal consent, and pregnant or breastfeeding women.