Investigation of dose response relationships in the use of low dose naltrexone (LDN) for patients with fibromyalgia
Fibromyalgia is a disease characterized by widespread pain, poor sleep quality, fatigue, cognitive dysfunction, reduced functional ability and poor quality of life. Treatment has so far been limited to treating symptoms. New evidence suggests that the symptoms of fibromyalgia may be caused or maintained by inflammation in the central nervous system, where activated glia cells produces pro-inflammatory cytokines, that lead to augmentation of pain signals and gives rise to a sickness syndrome. Low dose naltrexone (LDN) acts on toll-like receptors in glia cells, and might be a possible new disease modifying treatment for fibromyalgia. Until now LDN for fibromyalgia has only been investigated in few clinical trials and only 4,5 mg has been tested.
The aim of the study is to investigate dose response relationships in the treatment of fibromyalgia with LDN. Doses from 0.75 mg to 6 mg will be tested using the "up-and-down-method".
Another aim of the study is to test different outcome measures, as the clinical experience with the drug is, that it often improves sleep quality and fatigue more than the pain.
The study will serve as a pre-study for a larger randomized, controlled study. \n
Description of the cohort
We expect to include up to 30 women in the age range of 18-60, who meet both the ACR-1990 and 2010 criteria for fibromyalgia. The patients will be recruited when referred to or discharged from treatment at our pain center.
Data and biological material
Questionnaire based data are collected about daily pain, fibromyalgia specific symptoms, other symptoms and sleep quality at baseline and during treatment. After treatment data are collected about subjective positive and negative effects of the treatment.
RedCap is used for datacollection.
Collaborating researchers and departments
Department of Anesthesiology and Intensive Care, Odense University Hospital
- Professor and Consultant Palle Toft, MD, PhD,
Pain Center South, Odense University Hospital
- Staff specialist Morten Rune Blichfeldt-Eckhardt, PhD
- Nurse Eva McGhee
- Consultant Gitte Handberg
- Postdoc Henrik Bjarke Vægter, PhD.
- Physician Laila Bendix, PhD
COHERE, Department of Business and Economics
- Professor Jørgen Trankjær Lauridsen, cand.scient.oecon, PhD
- Pharmacist Kristian Østergaard Nielsen
OPEN Odense Patient data Explorative Network, Odense University Hospital
- Associate Professor Katrine Hass Rubin, PhD
- Data manager Lars Søgaard
GCP-unit, Odense University Hospital
- GCP-coordinator Annie Steen