## Protocol Section
### Identification Module
**NCT ID:** NCT06296979

**Brief Title:** Effectiveness of Noninvasive Phrenic Nerve Neuromodulation in Shoulder Pain and Hepatobiliary Visceral Comorbidity.

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

#### Organization Study ID Info
**ID:** 0881-N-23
#### Organization
**Class:** OTHER
**Full Name:** University of Seville
### Status Module
#### Completion Date
**Date:** 2026-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-15

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-12

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-20

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-03-06
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-23
**Study First Submit QC Date:** 2024-03-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Seville

#### Responsible Party

**Investigator Affiliation:** University of Seville

**Investigator Full Name:** Angel Oliva Pascual-Vaca

**Investigator Title:** Doctor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

**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.

### Conditions Module

**Conditions:**

- Shoulder Pain

**Keywords:**

- phrenic nerve

- Shoulder Pain

- Nuromodulation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 34

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Procedure: common Physical therapy

**Label:** USUAL PHYSIOTHERAPY

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Device: Phrenic nerve neuromodulation

- Procedure: common Physical therapy

**Label:** Transcutaneous electrical nerve stimulation

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Transcutaneous electrical nerve stimulation

**Description:** 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.

**Name:** Phrenic nerve neuromodulation

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Transcutaneous electrical nerve stimulation

- USUAL PHYSIOTHERAPY

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

**Name:** common Physical therapy

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Numeric Pain Rating Scale

**Time Frame:** pre-treatment, 1 week, 4 week, 12 week.

#### Secondary Outcomes

**Description:** 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.

**Measure:** Algometry

**Time Frame:** pre-treatment, 1 week, 4 week, 12 week.

**Description:** 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.

**Measure:** Goniometry passive

**Time Frame:** pre-treatment, 1 week, 4 week, 12 week.

**Description:** 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.

**Measure:** Quick Dash questionnaire

**Time Frame:** pre-treatment, 1 week, 4 week, 12 week.

**Description:** 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.

**Measure:** Goniometriy active

**Time Frame:** pre-treatment, 1 week, 4 week, 12 week.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Over 18 years of age and under 64 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.

**Maximum Age:** 64 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** adolforosadoportillo@gmail.com

**Name:** Adolfo Rosado Portillo

**Phone:** 605663879

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Sevilla

**Contacts:**

***Contact 1:***

- **Email:** deseada.lopez.sspa@juntadeandalucia.es

- **Name:** Deseada López Carballo, Dra

- **Role:** CONTACT

**Country:** Spain

**Facility:** Centro de Salud Ronda Histórica

**Status:** RECRUITING

**Zip:** 41008

**Location 2:**

**City:** Sevilla

**Contacts:**

***Contact 1:***

- **Email:** aliciavalerio@hotmail.com

- **Name:** Alicia Valero Sáinz

- **Phone:** 649532242

- **Phone Ext:** +34

- **Role:** CONTACT

**Country:** Spain

**Facility:** Centro de Salud las Letanías

**Status:** RECRUITING

**Zip:** 41013

**Location 3:**

**City:** Sevilla

**Contacts:**

***Contact 1:***

- **Email:** fisioaljarafe@gmail.com

- **Name:** María Isabel Morilla Párraga

- **Phone:** 609582376

- **Phone Ext:** +34

- **Role:** CONTACT

**Country:** Spain

**Facility:** Centro de Salud Bellavista

**Status:** RECRUITING

**Zip:** 41014

#### Overall Officials

**Official 1:**

**Affiliation:** University of Seville

**Name:** Ángel Oliva Pascual-Vaca, Dr

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000018771

- Term: Arthralgia

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M21907

- Name: Shoulder Pain

- Relevance: HIGH

- As Found: Shoulder Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M20833

- Name: Arthralgia

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000020069

- Term: Shoulder Pain

### Misc Info Module

- Version Holder: 2024-05-24
