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Recruiting Phase 4 NCT05605639

NCT05605639 Phrenic Nerve Infiltration in Neck Pain

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Clinical Trial Summary
NCT ID NCT05605639
Status Recruiting
Phase Phase 4
Sponsor University of Seville
Condition Chronic Neck Pain
Study Type INTERVENTIONAL
Enrollment 60 participants
Start Date 2022-11-17
Primary Completion 2025-07

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 64 Years
Study Type INTERVENTIONAL
Interventions
BupivacainePlacebo (physiological saline serum infiltration)

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 60 participants in total. It began in 2022-11-17 with a primary completion date of 2025-07.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 Criteria

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

Contact & Investigator

Central Contact

Angel Oliva Pascual-Vaca, Dr

✉ angeloliva@us.es

📞 0034 954486524

Principal Investigator

Angel Oliva Pascual-Vaca, Dr

PRINCIPAL INVESTIGATOR

University of Seville

Frequently Asked Questions

Who can join the NCT05605639 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Chronic Neck Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT05605639 trial and what does that mean for participants?

Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.

Is NCT05605639 currently recruiting?

Yes, NCT05605639 is actively recruiting participants. Contact the research team at angeloliva@us.es for enrollment information.

Where is the NCT05605639 trial being conducted?

This trial is being conducted at Dos Hermanas, Spain, Seville, Spain.

Who is sponsoring the NCT05605639 clinical trial?

NCT05605639 is sponsored by University of Seville. The principal investigator is Angel Oliva Pascual-Vaca, Dr at University of Seville. The trial plans to enroll 60 participants.

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