In short
There are currently 2 ongoing clinical trials investigating new treatment approaches for fibromyalgia. These studies are exploring different methods to manage pain and improve quality of life for patients living with this chronic condition, which causes widespread body pain and tenderness.
Clinical trial locations
- Netherlands
- Spain
Study on Pain Relief for Fibromyalgia Patients with Trapezius Myofascial Syndrome Using Bupivacaine, Triamcinolone, and Sodium Chloride
This clinical trial, conducted in Spain, focuses on treating a specific type of muscle pain in patients with fibromyalgia. The study targets trapezius myofascial syndrome, which causes pain in the trapezius muscle, the large muscle extending over the back of the neck and shoulders.
Main inclusion criteria:
- Adults over 18 years old
- Confirmed fibromyalgia diagnosis based on established criteria
- Continuous pain in the upper trapezius area for more than three months
- Presence of tight muscle bands and trigger points in the trapezius muscle
- Pain level greater than 3 on both local and generalized pain scales
- Stable treatment for at least three months or no recent new treatments
- Use of weak pain relievers such as tramadol, codeine, paracetamol, or metamizol in the past three months
Main exclusion criteria:
- Absence of fibromyalgia with trapezius myofascial syndrome
- Allergies or adverse reactions to bupivacaine or triamcinolone
- Current participation in another clinical trial
- Pregnancy or breastfeeding
- History of substance abuse or dependency
- Recent surgery or planned surgery during the study period
- Severe mental health conditions that could affect study participation
- Other medical conditions that might interfere with the study
Study focus: The trial aims to compare the effectiveness of different treatments in reducing muscle pain and overall body pain. Researchers will use ultrasound-guided injections to deliver medications precisely into the muscle. Participants will be monitored over time to assess pain levels, fatigue, sleep quality, functional capacity, quality of life, and levels of anxiety or depression. Pain will be measured at weeks 2, 4, and 12 using a Visual Analogue Scale.
Investigational drugs: The study tests three different substances delivered through injection. Bupivacaine is a local anesthetic that numbs the treatment area to relieve pain. Triamcinolone acetonide is an anti-inflammatory steroid medication that helps reduce inflammation and pain. Physiological saline, a simple saltwater solution, is used as a control to compare the effectiveness of the active medications. Some participants will also receive a placebo.
Study on Psilocybin's Effect on Pain in Fibromyalgia Patients
This trial, taking place in the Netherlands, explores a novel approach to managing fibromyalgia pain. Researchers are investigating whether low doses of psilocybin, a compound found in certain mushrooms, can help reduce pain perception in patients with fibromyalgia.
Main inclusion criteria:
- Age between 18 and 65 years
- Body mass index between 18 and 30 kg/m²
- Confirmed fibromyalgia diagnosis according to American College of Rheumatology criteria
- Minimum pain score of 5 out of 10 on the Numerical Rating Scale
- Proficient knowledge of Dutch or English
- No regular use of psychotropic medications such as opiates, antidepressants, muscle relaxants, anticonvulsants, sleep aids, or benzodiazepines
- Willingness to avoid alcohol, coffee, tea, and energy drinks after midnight before study sessions
- Willingness not to drive or operate machinery for 24 hours after taking the study substance
- Willingness to refrain from taking psychoactive substances during the study
Main exclusion criteria:
- Individuals outside the specified age range
- No confirmed fibromyalgia diagnosis
- Members of vulnerable populations requiring special protection
- Individuals not meeting other specific health criteria
Study focus: The trial examines how psilocybin influences pain perception and whether it affects mood, thinking, and memory. Researchers will also investigate the compound's effects on certain proteins in the body, particularly Brain-Derived Neurotrophic Factor, which is involved in nerve growth and function. Blood samples will be taken to measure levels of inflammation-related substances. The study will explore whether suggestions given under hypnosis can alter psilocybin's effects on pain. Various assessments will be conducted during multiple sessions to evaluate changes in pain, mood, and other factors. The trial is expected to continue until mid-2026.
Investigational drug: Psilocybin is being studied for its potential to reduce pain in patients with fibromyalgia. In this trial, participants receive either a 5 mg or 10 mg dose of psilocybin in capsule form, or a placebo, taken orally. Psilocybin works by interacting with serotonin receptors in the brain, which may influence mood and pain perception. It is classified as a psychedelic compound.
Summary
These two ongoing clinical trials represent different approaches to managing fibromyalgia pain. The Spanish study focuses on localized muscle pain treatment using established pain management medications delivered through targeted injections, while the Netherlands trial explores the innovative use of psilocybin to potentially change how the brain processes pain signals. Both studies emphasize comprehensive assessment of pain levels, quality of life, and other symptoms affecting patients. The trials are geographically diverse, with one in Spain and one in the Netherlands, offering opportunities for patients in different European locations to participate in research that may advance treatment options for this challenging chronic condition.
