What is the mechanism of action of this treatment?

Spinal Cord Stimulation (SCS) and Dorsal Root Ganglion (DRG) Stimulation are neuromodulation techniques that treat chronic pain by altering pain signal transmission in the nervous system. These treatments use electrical impulses to modulate neural activity, which can inhibit the transmission of pain signals to the brain. This mechanism is significant for chronic pain patients as it offers targeted pain relief, potentially reducing the need for opioid medications and their associated risks. By directly addressing the neural pathways involved in pain perception, SCS and DRG provide an effective alternative for managing chronic pain, improving patients' quality of life.

What side effects are associated with this type of intervention?

Common treatments for chronic pain, such as Spinal Cord Stimulation (SCS) and Dorsal Root Ganglion (DRG) Stimulation, primarily aim to alter pain signal transmission. Known side effects of these neuromodulation techniques can include mild device-associated adverse events such as a warm sensation, numbness, redness, itching, tingling, muscle spasms, and localized pain in areas like the arm, shoulder, or neck. Serious adverse events are rare but can occur. It is important for patients to discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

Spinal Cord Stimulation (SCS) and Dorsal Root Ganglion (DRG) Stimulation are neuromodulation techniques used to manage chronic pain by altering pain signal transmission. These methods have been studied and utilized for conditions such as diabetic neuropathy and chronic back pain. While specific FDA approvals for these exact treatments are not detailed in the provided context, SCS has been widely recognized and used in clinical practice for various chronic pain conditions. Additionally, other neuromodulation techniques like transcutaneous electrical nerve stimulation (TENS) and transcranial magnetic stimulation (TMS) have been explored for their efficacy in pain management, though their FDA approval status for chronic pain may vary.

What other types of research exist?

Promising novel alternatives to SCS and DRG stimulation for chronic pain patients include: 1) Endoscopically-delivered miniaturized gastric stimulators that enhance slow wave regularity and amplitudes, 2) Percutaneous electrode systems delivering neurostimulating pulses for up to eight weeks, 3) Multichannel stimulation protocols delivering high-energy pulses in sequential fashion to enhance gastric emptying, 4) Two-channel pacing with reduced current requirements, and 5) Impedance-based, feedback-controlled pacers that activate based on the stomach's intrinsic contractile state. These methods are being developed to provide more effective and less invasive options for pain management.

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Neuromodulation Therapy

Neuromodulation Therapy for Chronic Pain (XANADO Trial)

N/A

Recruiting

Research Sponsored by Abbott Medical Devices

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is at least 18 years of age or older at the time of enrollment.

Subject has a baseline (with no stimulation) pain NRS of ≥ 6.

Must not have

Subject is bedridden.

Subject has tremors (e.g. Parkinson's disease or Familial tremors).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3 month

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing electrical treatments that change how nerves send pain messages to the brain. It focuses on people with diabetes or pre-diabetes who have chronic pain. The goal is to see if these treatments can reduce pain and improve patient care. Electrical nerve stimulation is used to alleviate pain by administering pulsed electrical currents through the skin.

Who is the study for?

This trial is for adults over 18 with diabetes or pre-diabetes experiencing chronic pain, who have a pain score of at least 6 and an HbA1C level ≥ 5.7%. Participants must consent to wear Fitbit® and Freestyle Libre devices, complete questionnaires, and follow study visits. Exclusions include pregnancy, other neuromodulation treatments, conditions affecting sensor use, irregular sleep/wake patterns that affect participation, being bedridden or part of vulnerable populations.

What is being tested?

The XANADO study tests the effectiveness of standard neuromodulation therapies (SCS or DRG) in managing chronic pain among diabetic patients. It also examines if data from wearable devices can predict patient-reported outcomes and inform care adjustments. The non-randomized trial involves regular assessments before, during, and after therapy trials.

What are the potential side effects?

While specific side effects are not listed for this observational study on neuromodulation therapies like SCS or DRG systems; generally such interventions may cause discomfort at the stimulation site, unwanted changes in nerve function leading to muscle weakness or sensory disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My usual pain level is 6 or higher without taking anything for it.

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I am scheduled to use the Abbott system for at least 7 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to get out of bed.

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I experience tremors, such as those from Parkinson's disease.

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I am getting or have a device implanted for my chronic pain.

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I have a bleeding disorder or severe nerve pain from shingles.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 3 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Subjects using Neuromodulation Therapy (SCS or DRG)Experimental Treatment1 Intervention

Patients will trial standard of care neuromodulation therapy (SCS or DRG), and if successful will proceed to a permanent implant.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Spinal Cord Stimulation (SCS) and Dorsal Root Ganglion (DRG) Stimulation are neuromodulation techniques that treat chronic pain by altering pain signal transmission in the nervous system. These treatments use electrical impulses to modulate neural activity, which can inhibit the transmission of pain signals to the brain. This mechanism is significant for chronic pain patients as it offers targeted pain relief, potentially reducing the need for opioid medications and their associated risks. By directly addressing the neural pathways involved in pain perception, SCS and DRG provide an effective alternative for managing chronic pain, improving patients' quality of life.

A narrative review and future considerations of spinal cord stimulation, dorsal root ganglion stimulation and peripheral nerve stimulation.