Assessing diabetic pain outcomes using neuromodulation therapies

External Sensing and Neuromodulation to Assess Diabetic Pain Outcomes

This study is testing if spinal cord and nerve stimulation can help people with diabetes-related chronic pain feel better and improve their overall care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Abbott Medical Devices (industry)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT05537662 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of neuromodulation therapies, specifically spinal cord stimulation (SCS) and dorsal root ganglion (DRG) stimulation, in patients suffering from chronic pain related to diabetes. It aims to collect and analyze physical and physiological data from participants to determine if these metrics can predict patient-reported outcomes and inform adjustments in care. The study will be conducted at a single center in the United States, involving a longitudinal approach to track changes over time. Participants will wear sensing devices and complete questionnaires throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic intractable back and/or leg pain related to diabetes and a pain score of 6 or higher.

Not a fit: Patients who do not have chronic pain or those with a pain score below 6 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management strategies for diabetic patients suffering from chronic pain.

How similar studies have performed: Other studies have shown promise in using neuromodulation therapies for chronic pain, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Subject must provide written informed consent prior to any clinical investigation-related procedure.
2. Subject is at least 18 years of age or older at the time of enrollment.
3. Subject's scheduled trial duration for the Abbott neuromodulation system is at least 7 days.
4. 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.
5. Subject agrees to take an A1C screening test prior to study enrollment and has a confirmed HbA1C level ≥ 5.7%.
6. Subject has a baseline (with no stimulation) pain NRS of ≥ 6.
7. Subject is willing to cooperate with the study requirements including completion of all office visits.
8. Subject agrees to wear the wearable sensing devices (Fitbit® and Freestyle Libre).
9. Subject agrees to answer questionnaires regularly for the duration of the study.

Exclusion Criteria:

1. Subject is enrolled, or intends to participate, in a competing or confounding clinical study, as determined by Abbott.
2. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
3. Subject is part of a vulnerable population.
4. 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 of the clinical investigation results.
5. Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, post-herpetic neuralgia.
6. 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.
7. Subject has already participated in a SCS trial period before enrolling in the study.
8. Subject engages in a profession or other activity that could be damaging to the wearable sensors, as determined by the investigator.
9. Subject has a physical condition that makes it difficult to wear the wearable sensors, as determined by the investigator.
10. Subject has tremors (e.g. Parkinson's disease or Familial tremors).
11. 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.
12. Subject is bedridden.

Where this trial is running

Chicago, Illinois

• Rush University Medical Center — Chicago, Illinois, United States (RECRUITING)

Study contacts

• Study coordinator: Bram Blomme

Conditions: Chronic Pain, ABT-CIP-10458, Neuromodulation System, SCS, Diabetic Pain, DRG