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Clinical Trials in Spain / NCT05605639
Recruiting Phase 4

Phrenic Nerve Infiltration in Neck Pain

NCT05605639 · tracked via the Priya Life Science Spain tracker
Phase
Phase 4
Started
2022-11-17
Last updated
2024-12-11

Condition(s) studied

Chronic Neck Pain

Investigational drug(s) / intervention(s)

Bupivacaine →Placebo (physiological saline serum infiltration)

Bupivacaine: 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 (physiological saline 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.

Study summary

Neck pain frequently present comorbidities in peridiaphragmatic organs. The innervation of these organs include the phrenic nerve. It is known that peridiaphragmatic organs trigger referred pain in the neck area. As well, previous studies have shown that visceral disorders increase sensitization in somatic tissues. This study aims to analyze the ability of phrenic nerve infiltration to diminish sensitization and improve neck symptoms in the absence of neurological, traumatic or infectious pathology that justifies the pain, by means of a randomized controlled trial.

Eligibility

Sex
ALL
Min age
18 Years
Max age
64 Years
Healthy volunteers
No
Inclusion Criteria: * Over 18 and under 64 years old * Patients attending to the physician or physical therapist with a main complaint of neck pain * Presentation of any peridiaphragmatic visceral disorder. * That the subject agrees to participate in the project by signing the informed consent. Exclusion Criteria: * Illness of neurological, traumatic, oncological, infectious or rheumatic (fibromyalgia, ankylosing spondylitis...) origin. * Uncooperative subject. * Severe psychiatric illness. * Loss of Cognitive Ability. * Contraindication to infiltration of the phrenic nerve. * History of head, spinal or upper limb surgery * History of infiltration for the neck pain in the previous 3 months * History of physical therapy for the neck pain in the previous 30 days

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Nacho Navarro Fisioterapia Dos Hermanas Seville Recruiting
Crux Roxa Seville Spain Recruiting

More University of Seville trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05605639 on ClinicalTrials.gov ↗ ← All trials in Spain