NCT06296979

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
Mar 2024Dec 2026

First Submitted

Initial submission to the registry

February 23, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

March 20, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

2.7 years

First QC Date

February 23, 2024

Last Update Submit

March 27, 2025

Conditions

Shoulder Pain

Keywords

phrenic nerveShoulder PainNuromodulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Algometry

    pre-treatment, 1 week, 4 week, 12 week.

  • Goniometry passive

    pre-treatment, 1 week, 4 week, 12 week.

  • Quick Dash questionnaire

    pre-treatment, 1 week, 4 week, 12 week.

  • Goniometriy active

    pre-treatment, 1 week, 4 week, 12 week.

Study Arms (2)

USUAL PHYSIOTHERAPY

ACTIVE COMPARATOR

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

Procedure: common Physical therapy

Transcutaneous electrical nerve stimulation

EXPERIMENTAL

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.

Device: Phrenic nerve neuromodulationProcedure: common Physical therapy

Interventions

Phrenic nerve neuromodulationDEVICE

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.

Transcutaneous electrical nerve stimulation
common Physical therapyPROCEDURE

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

Transcutaneous electrical nerve stimulationUSUAL PHYSIOTHERAPY

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centro de Salud Ronda Histórica

Seville, Sevilla, 41008, Spain

RECRUITING

Centro de Salud las Letanías

Seville, Sevilla, 41013, Spain

RECRUITING

Centro de Salud Bellavista

Seville, sevilla, 41014, Spain

RECRUITING

Centro de especialidades Morón de la Frontera

Morón de la Frontera, Seville, 41530, Spain

RECRUITING

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ángel Oliva Pascual-Vaca, Dr

    University of Seville

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adolfo Rosado Portillo

CONTACT

605663879adolforosadoportillo@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 23, 2024

First Posted

March 6, 2024

Study Start

March 20, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(4)