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New treatment option for Chronic Pain
Official title External Sensing and Neuromodulation to Assess Diabetic Pain Outcomes (XANADO)
ClinicalTrials.gov ID: NCT05537662
What this study is testing
- What it's testing
- This is a prospective, longitudinal, single-center, non-randomized, open-label, post-market clinical feasibility study to assess the efficacy of neuromodulation therapies (SCS and DRG) for chronic pain patients with diabetes and investigate whether physical and physiological data collected from diabetic and pre-diabetic chronic pain patients is predictive of subjective patient-reported outcomes (PROs) and of adjustments in patient care. These assessments will be made prior to, during, and after the trial of the SCS or DRG system.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject must provide written informed consent prior to any clinical investigation-related procedure.
- Subject is at least 18 years of age or older at the time of enrollment.
- Subject's scheduled trial duration for the Abbott neuromodulation system is at least 7 days.
- Subject is scheduled to undergo trial of an Abbott neuromodulation system for chronic intractable back and/or leg pain at least 7 days after...
- Subject agrees to take an A1C screening test prior to study enrollment and has a confirmed HbA1C level ≥ 5.7%.
You likely can't join if
- Subject is enrolled, or intends to participate, in a competing or confounding clinical study, as determined by Abbott.
- Pregnant or nursing people and those who plan pregnancy during the clinical investigation follow-up period.
- Subject is part of a vulnerable population.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could...
- Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, post-herpetic neuralgia.
- Subject has, or is scheduled to receive, implantation of another neuromodulation system (e.g. DRG or SCS system or intrathecal pump) to address their...
See the full eligibility criteria
- Subject must provide written informed consent prior to any clinical investigation-related procedure.
- Subject is at least 18 years of age or older at the time of enrollment.
- Subject's scheduled trial duration for the Abbott neuromodulation system is at least 7 days.
- Subject is scheduled to undergo trial of an Abbott neuromodulation system for chronic intractable back and/or leg pain at least 7 days after enrollment and commencement of the baseline data collection period.
- Subject agrees to take an A1C screening test prior to study enrollment and has a confirmed HbA1C level ≥ 5.7%.
- Subject has a baseline (with no stimulation) pain NRS of ≥ 6.
- Subject is willing to cooperate with the study requirements including completion of all office visits.
- Subject agrees to wear the wearable sensing devices (Fitbit® and Freestyle Libre).
- Subject agrees to answer questionnaires regularly for the duration of the study.
- Subject is enrolled, or intends to participate, in a competing or confounding clinical study, as determined by Abbott.
- Pregnant or nursing people and those who plan pregnancy during the clinical investigation follow-up period.
- Subject is part of a vulnerable population.
- 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...
- Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, post-herpetic neuralgia.
- Subject has, or is scheduled to receive, implantation of another neuromodulation system (e.g. DRG or SCS system or intrathecal pump) to address their chronic pain.
- Subject has already participated in a SCS trial period before enrolling in the study.
- Subject engages in a profession or other activity that could be damaging to the wearable sensors, as determined by the investigator.
- Subject has a physical condition that makes it difficult to wear the wearable sensors, as determined by the investigator.
- Subject has tremors (e.g. Parkinson's disease or Familial tremors).
- Subject has sleep/wake schedule that would present a challenge in completing all clinical site visits or in use of the wearable devices and engagement in the surveys via the mobile device.
- Subject is bedridden.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.