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Micro-Implantable Pulse Generator for Chronic Pain (COMFORT Trial)
COMFORT Trial Summary
This trial is testing whether adding peripheral nerve stimulation to conventional medical management is more effective and safe than just using conventional medical management for chronic, intractable peripheral neuralgia that is of post-traumatic or post-surgical origin.
COMFORT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCOMFORT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.COMFORT Trial Design
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Who is running the clinical trial?
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- I do not experience pain when I am resting.I can correctly place the adhesive clip or use the relief belt/cuff for the therapy disc.I have a diagnosed nerve pain condition like CRPS or Charcot-Marie-Tooth Disease.I would be prescribed PNS therapy even if I wasn't part of this study, and using the Nalu device is appropriate for my condition.I have been on a stable pain medication plan for the last 30 days.I've had a specific nerve treatment but not on my spinal cord or the nerve in this study.I have cancer that has spread or shows signs of affecting my body in unusual ways.I have diabetes with uncontrolled blood sugar and nerve damage.I have nerve or joint pain in my back, shoulder, knee, or foot due to surgery, injury, or arthritis.My depression or psychiatric condition is not under control.You are allergic to the materials used in the device or cannot tolerate wearing the device.I have a bleeding or clotting disorder, or severe vascular disease that hasn't been treated.My pain levels have been stable for the last 60 days.I am between 18 and 80 years old.My pain level in the target area is at least 6 out of 10.I currently have an infection that affects my whole body.I have had severe nerve pain in my body, excluding my face, for over 6 months.I take 90 mg or more of pain medication equivalent to morphine daily.I have had severe nerve pain in my body, excluding my face, for over 6 months.I have nerve or joint pain in my back, shoulder, knee, or foot due to surgery, injury, or arthritis.My pain level in the target area is at least 6 out of 10.I've had a procedure in the last 3 months that reduced my pain by at least half.I have tried and not benefited from nerve or spinal cord stimulation therapies.You are mentally able to receive a peripheral nerve stimulator and don't have psychological conditions that would affect your ability to report your experiences or finish the study tasks.
- Group 1: Conventional Medical Management
- Group 2: PNS Therapy plus Conventional Medical Management
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the primary objective of this trial?
"According to the data provided by Nalu Medical, Inc., this trial's principal outcome will be evaluated over a 3-month timeframe. This primary indicator of success is titled "Effectiveness: Responder Rates between groups" and assesses the percentage of patients who have experienced pain relief exceeding 50% from their baseline as measured on the BPI-Q5(NRS). Additionally, secondary outcomes such as safety assessment (which looks into serious & non-serious events), functional outcomes (change in ODI, BDI, EQ-5D and BPI scores) and responder rates at 6 months are also being monitored."
Is there an opportunity for me to participate in this experiment?
"This clinical trial is currently seeking 100 individuals, aged 18 to 80, who present with chronic pain. All patients must meet the specified criteria which include: having a diagnosis of post-surgical/post-traumatic peripheral neuralgia in one of four areas (low back, shoulder knee or foot), experiencing intractable neuropathic pain for at least six months and reporting a BPI score of 6 or higher; being psychologically equipped to receive PNS therapy through standard practice; displaying the capacity to correctly place an adhesive clip on their body where necessary; taking stable CMM medication for 30 days prior to enrolment and not escalating their dose within"
Is this research initiative currently recruiting participants?
"According to clinicaltrials.gov, this research trial is actively searching for participants with the posting date of January 31st 2022 and last modified on March 10th 2022."
Does this research endeavor accept enrollees who are younger than 75 years of age?
"To be considered for inclusion on this trial, applicants must meet the age criteria of 18 to 80. Additionally, there are 39 different trials available for those below 18 and 480 tailored towards seniors aged 65 or above."
What is the current number of participants in this research endeavor?
"Affirmative. Clinicaltrials.gov indicates that this clinical trial, which was initially posted on the 31st of January 2022, is currently recruiting volunteers. 100 individuals need to be sourced from 5 distinct sites for participation in the study."
How many sites have been chosen to conduct this research?
"Currently, 5 clinics are enrolling patients in this medical trial. Institutions such as the Institute of Precision Pain Medicine and International Spine, Pain and Performance Center have joined alongside Denver Back pain Specialists, with a few other locations joining them."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Average response time
- < 1 Day
Typically responds via
Most responsive sites:
- Arizona Pain Specialists: < 24 hours
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