Health TrialsbyHealthPanel

Phrenic Nerve Infiltration in Neck Pain

ConditionChronic Neck Pain
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-64
SponsorUniversity of Seville

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Illness of neurological, traumatic, oncological, infectious or rheumatic (fibromyalgia, ankylosing spondylitis...) origin.

Uncooperative subject.

Severe psychiatric illness.

Loss of Cognitive Ability.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bupivacaine

    Drug

    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)

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Phrenic nerve anesthetics infiltrationExperimental treatment 1 intervention
Group B: Physiological serum infiltrationPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in algometry

Pressure pain threshold in neck tissues. PPT levels defined as the minimum necessary pressure to evoke pain will be evaluated using a handheld electronic pressure algometer.

Time frame
Pre-intervention. Post-intervention: 1 hour, 2 hours, 3 days and 7 days

Secondary outcomes

1

Range of motion

Neck range of motion.The range of motion will be assessed in degrees. Flexion, extension, left and right side flexion, and left and right rotation will be assessed, and the sum of all of those parameters will be the considered outcome.

Time frame
Pre-intervention. Post-intervention: 1 hour, 2 hours, 3 days and 7 days
2

Visual Analogue Scale

Perceived neck pain. Self-perceived pain intensity will be evaluated during all active cervical movements by a 0 to 10 Visual Analogue Scale (VAS), where 0 denotes no pain and 10 denotes the maximum possible pain.

Time frame
Pre-intervention. Post-intervention: 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, 2 days, 3 days and 7 days
3

Neck Disability Index

Neck Disability Index (Questionnaire). The Neck Disability Index will be used in the Spanish version. This questionnaire assesses how neck pain affects the ability to manage everyday-life activities. Scores range from 0-50 with higher scores indicating higher disability.

Time frame
Pre-intervention. Post-Intervention: 3 days and 7 days.
4

Headache Impact Test-6

Headache Impact Test (Questionnaire). The Headache Impact Test-6 was developed to measure a wide spectrum of the factors contributing to the burden of headache, and it has demonstrated utility for generating quantitative and pertinent information on the impact of headache. Scores range from 0-120 with higher scores indicating a worse outcome.

Time frame
Pre-intervention. Post-intervention: 3 days and 7 days.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Seville

Lead sponsor

Source ClinicalTrials.gov
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