Peripheral Neuropathy Trial, Recruiting NCT06413277 Sponsor: Ainsworth Institute of Pain Management Condition: Peripheral Neuropathy
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Peripheral Neuropathy Trial, Recruiting

NCT06413277
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • The person must be 18 years of age or older at the time of joining the trial.
  • The person must have a pain score of at least 60 out of 100 on a standard pain scale at the start of the trial.
  • The person must have long-term, hard-to-treat pain in the trunk or limbs related to the pelvic, genital, perineal, or anorectal area, and standard treatments must not have worked for at least 6 months.
  • The person's pain must have resulted from a known injury, such as surgery or physical trauma.
  • The person must have been diagnosed with chronic pelvic pain — this may include conditions such as complex regional pain syndrome (CRPS), pain after surgery or injury, interstitial cystitis/painful bladder syndrome, pain after hysterectomy or prostate surgery, vulvodynia, chronic ovarian pain, or pudendal neuralgia with a known cause.
  • The treating doctor must have determined that the person is a suitable candidate for the surgical procedures involved in this trial.
  • The person must be willing and able to give informed consent to participate.
  • The person must be willing and able to follow all study requirements, attend required visits, and complete all study procedures.

Who may not be able to join:

  • People who are pregnant or breastfeeding.
  • People who are involved in a legal claim related to their injury or pain, or who have a current or approved workers' compensation claim.
  • People whose cause of pain is unknown.
  • People where the suspected cause of pain began more than 30 days before the pain itself started.
  • People who have a history of small fiber neuropathy, mitochondrial disease, fibromyalgia, addiction, CRPS in a second pain area, or atypical facial pain.
  • People who have been diagnosed with Crohn's disease, irritable bowel syndrome, ulcerative colitis, or any other ongoing inflammatory bowel or digestive condition.
  • People who have another medical condition or pain in a different area of the body that is not being treated in this trial and that could interfere with the study, as decided by the study doctor.
  • People who have a history of sexual abuse or sexual trauma.
  • People who have a history of depression or anxiety that was not managed and that began before their pain symptoms started.
  • People who are currently taking more than 100 morphine milligram equivalents (MME) of opioid pain medication per day.
  • People who show signs of an active or significant psychological or psychiatric condition that could affect how pain is perceived, how well the person follows the treatment, or how outcomes are measured.
  • People who have previously used spinal cord stimulation (SCS) or dorsal root ganglion (DRG) stimulation as a pain treatment.
  • People who already have an implanted drug pump, spinal cord stimulator, pacemaker, deep brain stimulator, sacral nerve stimulator, or any other active implanted device.
  • People who are currently taking part in another clinical trial.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Corey W Hunter, MD, FIPP, Ainsworth Institute of Pain Management

Phone: (212) 203 2813

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Ainsworth Institute of Pain Management
Registry
ClinicalTrials.gov
Start date
5 February 2024
Est. completion
1 January 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Efficacy: Proportion of patients achieving at least 50% and 80% relief from pelvic pain and pelvic pain-related negative impact to quality of life compared to baseline

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov