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NCT Number: NCT06296979

Effectiveness of Noninvasive Phrenic Nerve Neuromodulation in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Salud Ronda Histórica, Seville, Sevilla, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Phrenic nerve neuromodulation

Device

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.

common Physical therapy

Procedure

the usual treatment of the center consisting of manual therapy, exercise and thermotherapy will be performed.

Primary outcomes

  1. Numeric Pain Rating Scale

    Time frame: pre-treatment, 1 week, 4 week, 12 week.

    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.

Secondary outcomes

  1. Algometry

    Time frame: pre-treatment, 1 week, 4 week, 12 week.

    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.

  2. Goniometry passive

    Time frame: pre-treatment, 1 week, 4 week, 12 week.

    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.

  3. Quick Dash questionnaire

    Time frame: pre-treatment, 1 week, 4 week, 12 week.

    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.

  4. Goniometriy active

    Time frame: pre-treatment, 1 week, 4 week, 12 week.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Adolfo Rosado Portillo

CONTACT

[email protected]

605663879

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2024
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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