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Search / Trial NCT06527183

Fibromyalgia and Small Fiber Neuropathy

Launched by HOSPITAL AMBROISE PARÉ PARIS · Jul 24, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a condition called fibromyalgia, which is a type of chronic pain syndrome. Specifically, the researchers want to find out how many patients with fibromyalgia have a related condition called small fiber neuropathy, which affects the tiny nerves in the skin and can cause pain and sensitivity. They will compare these patients to others with different types of chronic pain and to healthy individuals. To do this, they will use tests that check for nerve damage and how the body responds to pain.

If you are over 18 years old, have been experiencing chronic pain for at least six months, and are part of the French social security system, you may be eligible to participate. Participants should be able to understand and follow the study instructions and have a normal neurological exam. Throughout the trial, you can expect to undergo several tests to evaluate nerve function and pain perception. It's important to know that some conditions, like recent cancer, other neurological diseases, or uncontrolled health issues, could exclude you from participating. This study aims to better understand the relationship between fibromyalgia and small fiber neuropathy, which could lead to improved treatments for those suffering from chronic pain.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • patients over 18 years of age with no age limit -
  • having given their signed consent to take part in the study
  • affiliated to the French social security system
  • able to be followed for the entire duration of the study
  • reading and understanding French
  • accepting the principle of the study and able to comply with its conditions
  • suffering from chronic pain for at least six months of at least moderate intensity (≥ 4/10)
  • fibromyalgia detected by the FiRST questionnare and defined by the revised diagnostic criteria of the WHO or chronic nociceptive or nociplastic pain without associated fibromyalgia.
  • chronic pain for at least 6 months of at least moderate intensity (≥ 4/10)
  • untreated or with stable analgesic treatment for at least 2 weeks prior to inclusion- normal neurological examination at inclusion
  • Exclusion Criteria:
  • litigation or compensation-seeking
  • cancer for less than 2 years
  • known cause of small-fiber neuropathy such as diabetes, systemic disease, hypothyroidism, alcohol, renal failure, genetic disease
  • clinical or EMG neuropathy
  • peripheral or central nervous system pathology with or without associated neuropathic pain
  • uncontrolled chronic pathology such as : morbid obesity, sleep apnea, uncontrolled hypertension, etc. - psychosis, previous suicide attempt
  • drug or psychoactive substance abuse
  • cognitive or psychological disorders incompatible with compliance with and/or understanding of the protocol
  • participation in another biomedical research protocol.

About Hospital Ambroise Paré Paris

Hospital Ambroise Paré in Paris is a leading healthcare institution dedicated to advancing medical research and patient care. As a clinical trial sponsor, it focuses on innovative therapeutic approaches and cutting-edge treatments across various medical fields. The hospital is committed to fostering collaboration among multidisciplinary teams of healthcare professionals, researchers, and clinical experts to enhance the quality of clinical trials. With a strong emphasis on patient safety and ethical standards, Hospital Ambroise Paré aims to contribute significantly to the development of new medical therapies that improve patient outcomes and advance the field of medicine.

Locations

Boulogne Billancourt, , France

Paris, , France

Patients applied

0 patients applied

Trial Officials

Nadine ATTAL, MD PhD

Principal Investigator

APHP

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported