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Clinical Trial NCT06296979 for Shoulder Pain is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Effectiveness of Noninvasive Phrenic Nerve Neuromodulation in Shoulder Pain and Hepatobiliary Visceral Comorbidity. 34
Clinical Trial NCT06296979 is an interventional study for Shoulder Pain that is recruiting. It started on 20 March 2024 with plans to enroll 34 participants. Led by University of Seville, it is expected to complete by 1 December 2026. The latest data from ClinicalTrials.gov was last updated on 2 April 2025.
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 ...Show More
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 syste...Show More
Official Title
Effectiveness of Noninvasive Phrenic Nerve Neuromodulation in Subjects With Right Shoulder Pain and Hepatobiliary Visceral Comorbidity.
Conditions
Shoulder PainOther Study IDs
- 0881-N-23
NCT ID Number
Start Date (Actual)
2024-03-20
Last Update Posted
2025-04-02
Completion Date (Estimated)
2026-12-01
Enrollment (Estimated)
34
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
phrenic nerve
Shoulder Pain
Nuromodulation
Shoulder Pain
Nuromodulation
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorUSUAL PHYSIOTHERAPY the usual treatment of the center consisting of manual therapy, exercise and thermotherapy will be performed. | common Physical therapy the usual treatment of the center consisting of manual therapy, exercise and thermotherapy will be performed. |
ExperimentalTranscutaneous 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. | 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. common Physical therapy the usual treatment of the center consisting of manual therapy, exercise and thermotherapy will be performed. |
Primary Outcome Measures
Secondary 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. |
| 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. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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.
University of SevilleStudy Responsible Party
Angel Oliva Pascual-Vaca, Principal Investigator, Doctor, University of Seville
Study Central Contact
Contact: Adolfo Rosado Portillo, 605663879, [email protected]
4 Study Locations in 1 Countries
Sevilla
Centro de Salud Ronda Histórica, Seville, Sevilla, 41008, Spain
Deseada López Carballo, Dra, Contact, [email protected]
Recruiting
Centro de Salud las Letanías, Seville, Sevilla, 41013, Spain
Alicia Valero Sáinz, Contact, 649532242, [email protected]
Recruiting
sevilla
Centro de Salud Bellavista, Seville, sevilla, 41014, Spain
María Isabel Morilla Párraga, Contact, 609582376, [email protected]
Recruiting
Seville
Centro de especialidades Morón de la Frontera, Morón de la Frontera, Seville, 41530, Spain
Antonio Jesús Morilla González, Physiotherapist, Contact, 603049432, [email protected]
Recruiting