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Nerve Stimulation for Chronic Pain (COMFORT 2 Trial)
COMFORT 2 Trial Summary
This trial is studying if nerve stimulation plus medical care is better than medical care alone to treat chronic nerve pain due to trauma or surgery.
COMFORT 2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCOMFORT 2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.COMFORT 2 Trial Design
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- I have had a procedure to treat a nerve or its roots for pain relief.I do not have uncontrolled depression or psychiatric disorders.You are mentally ready to get a nerve stimulator and don't have any psychological conditions that would affect your ability to report your experiences or complete the study tasks.I have a diagnosed nerve pain condition like CRPS or neuropathy.I would have been prescribed PNS therapy even if I wasn't joining this study.My pain level in the target area is at least a 6 out of 10.I have diabetes that is not well-managed and I am experiencing nerve pain.I currently have an infection that affects my whole body.I do not experience pain when I am resting.I have a bleeding or clotting disorder, or a worsening blood vessel disease that hasn't been treated.I have long-lasting nerve pain in my body, not including my face, that is worse than any other pain.My pain levels have been stable for the last 60 days.I've been on a stable pain medication plan for the last 30 days.I have nerve or joint pain in my back, shoulder, knee, or foot due to surgery, injury, or arthritis.I am between 18 and 80 years old.I take 90 mg or more of pain medication equivalent to morphine daily.I have tried and not benefited from nerve or spinal cord stimulation treatments.I've had a procedure in the last 3 months that reduced my pain by at least half.You have unresolved legal issues or other conflicts related to your chronic pain condition.Your doctor expects you to live for less than a year.I have cancer that has spread or shows signs of affecting my body in unusual ways.I can correctly use the device needed for my treatment.
- Group 1: PNS Therapy plus Conventional Medical Management (CMM)
- Group 2: 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
Is there any opportunity for me to participate in this clinical experiment?
"In order to partake in this trial, individuals must be between 18 and 80 years old and suffer from chronic pain. A total of 100 participants are being sought after for the study."
Does this research encompass individuals aged 55 and up?
"This trial is open to individuals aged between 18 and 80 years old. There are 49 studies available for minors, while there is a total of 629 related trials catering towards the elderly population."
Is this clinical trial recruiting participants at present?
"Affirmative. As per information hosted on clinicaltrials.gov, this medical trial is actively searching for participants. It was first introduced to the public on April 28th 2023 and has since been updated as recent as May 11th 2023 - the study seeks to enrol 100 patients across 2 sites."
How many individuals are being followed in this clinical trial?
"Affirmative, the clinicaltrials.gov website alludes to this study actively seeking participants. It was initially made available on April 28th 2023 and last updated on May 11th of that same year. The investigation necessitates 100 individuals from two separate sites."
What specific objectives are being sought by this experimental protocol?
"Per the clinical trial sponsor, Nalu Medical, Inc., this medical study's primary objective over a 3-month period will be to evaluate safety by analysing serious and non-serious device effects. Secondary objectives include recording changes in Oswestry Disability Index (ODI) score from baseline with comparison between groups; assessing change in Beck's Depression Inventory (BDI) score from baseline along with comparison between two cohorts; and gauging Patient Global Impression of Change (PGIC). ODI is measured on 0-100% disability scale whereas BDI is rated from 0-63 points while PGIC uses 7 point likert scale"
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