Effectiveness of Noninvasive Phrenic Nerve Neuromodulation in Shoulder Pain and Hepatobiliary Visceral Comorbidity.

Effectiveness of Noninvasive Phrenic Nerve Neuromodulation in Subjects With Right Shoulder Pain and Hepatobiliary Visceral Comorbidity.

Pain, particularly shoulder pain, is a social and economic problem worldwide. Although visceral pathology is not yet taken into account in the diagnosis of these pains, it is likely that on numerous occasions the hepatobiliary visceral condition causes referred pain in the metameric area belonging to the shoulder due to the involvement of the phrenic nerve. Therefore, the aim of this project is to study the response of treatment by neuromodulation of the phrenic nerve for shoulder pain in patients with associated hepatobiliary pathologies, assessing the possible visceral involvement in the symptomatology.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Pain
• Intervention / Treatment: Procedure: common Physical therapy; Device: Phrenic nerve neuromodulation

Detailed Description

Approximately 80% of patients with liver disease suffer chronic pain and fatigue, which can lead to sensitization of the central and peripheral nervous system. Central sensitization is an increase in the responsiveness of neurons within the central nervous system, which can lead to generalized pain hypersensitivity. It has been shown that some lesions or inflammatory processes can trigger changes in the nervous system, generating persistent pain.

According to the theory of visceral referred pain, there are visceral and musculoskeletal stimuli that converge in higher centers capable of producing referred pain in regions where metameric innervation is shared. This raises the possibility that altered visceral mechanisms may provoke and chronify musculoskeletal pain.

According to this theory, people with structural or functional hepatobiliary pathologies may have referred pain in the right metameric territory of C2-C3-C4-C5, which may generate pain in the shoulder on the same side. This is due to the fact that the phrenic nerve sensitively innervates Glisson's capsule, so any affectation of this structure can generate afferent stimuli to the previously mentioned metameric levels.

The phrenic hypothesis plays a very important role today, having as its main "endorsement" the analgesic techniques of phrenic blockade used for shoulder pain after hepatectomy. In order to eliminate this post-operative shoulder pain, electrical or medical nerve blocks are used.

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adolfo Rosado Portillo; Phone Number: 605663879; Email: adolforosadoportillo@gmail.com

Study Locations

• Spain
  • Sevilla, Spain, 41008
    • Recruiting
    • Centro de Salud Ronda Histórica
    • Contact: Deseada López Carballo, Dra; Email: deseada.lopez.sspa@juntadeandalucia.es
  • Sevilla, Spain, 41013
    • Recruiting
    • Centro de Salud las Letanías
    • Contact: Alicia Valero Sáinz; Phone Number: +34 649532242; Email: aliciavalerio@hotmail.com
  • Sevilla, Spain, 41014
    • Recruiting
    • Centro de Salud Bellavista
    • Contact: María Isabel Morilla Párraga; Phone Number: +34 609582376; Email: fisioaljarafe@gmail.com
  • Seville
    • Morón de la Frontera, Seville, Spain, 41530
      • Recruiting
      • Centro de especialidades Morón de la Frontera
      • Contact: Antonio Jesús Morilla González, Physiotherapist; Phone Number: +34 603049432; Email: amorogon@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Over 18 years of age.
• Subjects presenting right shoulder pain at the time of enrollment in the study.
• Presentation of a hepatobiliary visceral disorder that may justify the visceral etiology of the pain.
• That they agree to participate in the project by signing the informed consent form.

Exclusion Criteria:

• Patients with chronic pain due to other diseases such as malignant disease.
• Patients with rheumatic diseases.
• Cutaneous infection in the area of pain.
• Disease of neurological, traumatic, oncologic, or infectious origin that rules out the visceral origin of the pain.
• Uncooperative subject.
• Severe psychiatric disease.
• Loss of cognitive capacity.
• Contraindication to electrotherapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: USUAL PHYSIOTHERAPY; the usual treatment of the center consisting of manual therapy, exercise and thermotherapy will be performed.	Procedure: common Physical therapy; the usual treatment of the center consisting of manual therapy, exercise and thermotherapy will be performed.
Experimental: Transcutaneous electrical nerve stimulation; The intervention group will receive the usual physiotherapy treatment at the health center and will also receive neuromodulation on the phrenic nerve at its exit through the anterior cervical region. The neuromodulation technique will be applied for 10 minutes.	Procedure: common Physical therapy; the usual treatment of the center consisting of manual therapy, exercise and thermotherapy will be performed.; Device: Phrenic nerve neuromodulation; The intervention group will receive the usual physiotherapy treatment at the health center and will also receive neuromodulation on the phrenic nerve at its exit through the anterior cervical region. The neuromodulation technique will be applied for 10 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Pain Rating Scale	Perceived pain. Self-perceived pain intensity will be evaluated by a 0 to 10 Numeric Pain Rating Scale (NPRS), where 0 denotes no pain and 10 denotes the maximum possible pain.	pre-treatment, 1 week, 4 week, 12 week.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Algometry	Pain threshold to pressure at specific tender points of the shoulder: infraspinatus, deltoid and trapezius. PPT levels defined as the minimum pressure required to evoke pain will be assessed using a portable electronic pressure algometer. Change from baseline on algometry. The units of measurement of pressure pain will be Kg/cm2.	pre-treatment, 1 week, 4 week, 12 week.
Goniometry passive	measurement of passive pain-free ranges of motion of flexion, internal rotation, external rotation and abduction of the right shoulder with a portable goniometer. the unit of measurement shall be the degree of movement.	pre-treatment, 1 week, 4 week, 12 week.
Quick Dash questionnaire	Questionnaire that measures the function of the upper limb. It is composed of 11 items that are rated from 1 to 5, from least to most difficult to perform certain movements.	pre-treatment, 1 week, 4 week, 12 week.
Goniometriy active	measurement of active pain-free ranges of motion of flexion, internal rotation, external rotation and abduction of the right shoulder with a portable goniometer. the unit of measurement shall be the degree of movement.	pre-treatment, 1 week, 4 week, 12 week.

Collaborators and Investigators

• Sponsor: University of Seville
• Investigators: Principal Investigator: Ángel Oliva Pascual-Vaca, Dr, University of Seville

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Shoulder Pain; phrenic nerve; Nuromodulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Joint Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: 0881-N-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No