Clinical trial NCT05605639: Phrenic Nerve Infiltration in Neck Pain
Official title: Phrenic Afferences In Organic and Metabolic Illness: Central Sensitization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Chronic Neck Pain
Keywords: phrenic nerve
anesthesia, local
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Pain is a major problem due to issues such as the impact on quality of life and the associated health and social costs. Neck pain is a very common disorder in our society. It is characterized by the presence of hyperalgesia, increased muscle tone, limited range of motion and sensitization. It is well known that pain of visceral origin can generate all these phenomena. In most cases, there is no antecedent of trauma, and no evidence of a specific origin (oncologic, rheumatic, infectious...), so patients are classified as suffering non-specific or idiopathic pain. The absence of a specific diagnosis makes it difficult to find a therapeutic target to increase the probability of successful therapies. Thus, in the case of neck pain, the recurrence of consultations is very high.

It is known that cervical pain frequently presents peridiaphragmatic visceral comorbidities. Furthermore, it is known that these peridiaphragmatic organs produce referred pain to the neck, and this pain is known as phrenic pain. To date, there are no studies that analyze the role of phrenic afferents in subjects with neck pain and peridiaphragmatic visceral disorders. The aim of this study is to evaluate the effect of phrenic nerve anaesthesia in subjects with neck pain. For this purpose, the investigators intend to perform a randomised clinical trial, assessing the effects on pain threshold to pressure, visual analogue scale, range of motion and craniocervical questionnaires. There will be only one intervention session. The experimental group will receive an ultrasound-guided anaesthetic infiltration of the phrenic nerve, while the control group will receive a placebo infiltration. A one-week follow-up, with intermediate measurements, will be carried out to assess the evolution of cervical sensitization and symptomatology.

The results of this study will make it possible to establish the role of peridiaphragmatic organic disorders and phrenic afferents in cervical pain, thus making it possible to specify a specific therapeutic target (phrenic nerve) as well as the importance of visceral treatment in subjects presenting for consultation for cervical pain.

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

Primary outcomes:
measure: Change from baseline in algometry
timeFrame: Pre-intervention. Post-intervention: 1 hour, 2 hours, 3 days and 7 days
Secondary outcomes:
measure: Range of motion
timeFrame: Pre-intervention. Post-intervention: 1 hour, 2 hours, 3 days and 7 days
measure: Visual Analogue Scale
timeFrame: Pre-intervention. Post-intervention: 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, 2 days, 3 days and 7 days
measure: Neck Disability Index
timeFrame: Pre-intervention. Post-Intervention: 3 days and 7 days.
measure: Headache Impact Test-6
timeFrame: Pre-intervention. Post-intervention: 3 days and 7 days.
Other outcomes:
Locations:
city: Dos Hermanas
country: Spain
facility: Nacho Navarro Fisioterapia
state: Seville
city: Seville
country: Spain
facility: Crux Roxa
Study officials:
affiliation: University of Seville
name: Angel Oliva Pascual-Vaca, Dr
role: PRINCIPAL_INVESTIGATOR
References: