Phrenic Afferences In Organic and Metabolic Illness: Central Sensitization - Fibromyalgia

Status: Completed
Location: See all (4) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

It is known that nociceptive afferences in visceral pain and visceral disorders increase sensitization in subjects suffering from fibromyalgia. These patients use to present visceral comorbidities. Those comorbidities include that of peridiaphragmatic organs, which are supplied by the phrenic nerve among other innervations. It is known that peridiaphragmatic organs trigger referred pain in the neck area, via the phrenic nerves. So, the phrenic nociceptive afferences can be contributing to enhance the state of sensitization in fibromyalgia. This study aims to analyze the ability of phrenic nerve infiltration to diminish sensitization in subjects suffering fibromyalgia, by means of a randomized controlled trial.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:

• Women

• Over 18 and under 64 years old

• Diagnosis of Fibromyalgia

• Any peridiaphragmatic visceral disorder diagnosed by the respective specialist.

• That the subject agrees to participate in the project by signing the informed consent.

Locations
Other Locations
Spain
Nacho Navarro Fisioterapia
Dos Hermanas
Asociación de Fibromialgia de Lebrija
Lebrija
Asociación de Fibromialgia de Sevilla
Seville
Hospitales Universitarios Virgen del Rocío y Macarena
Seville
Time Frame
Start Date: 2023-04-03
Completion Date: 2024-02-19
Participants
Target number of participants: 60
Treatments
Experimental: Phrenic nerve anesthetics infiltration
The experimental intervention will consist of ultrasound-guided anesthetic blockade of the phrenic nerve at the laterocervical supraclavicular level with 1 ml of lidocaine without vasoconstrictor 2% to infiltrate the skin and 3ml of bupivacaine without vasoconstrictor 0.25% for neural blockade, making the local anesthetic surround the nerve between the anterior scalene muscle and the sternocleidomastoid muscle.
Placebo_comparator: Physiological serum infiltration
The placebo intervention will be similar in relation to 2% lidocaine without vasoconstrictor for the skin, but an ultrasound-guided puncture will be performed at the level of the subcutaneous cellular tissue by injecting 3 ml of physiological saline.
Related Therapeutic Areas
Sponsors
Leads: University of Seville

This content was sourced from clinicaltrials.gov