Shoulder PainNCT06296979
Effectiveness of Noninvasive Phrenic Nerve Neuromodulation in Shoulder Pain and Hepatobiliary Visceral Comorbidity.
A study testing Phrenic nerve neuromodulation and common Physical therapy in people with Shoulder Pain, run by University of Seville at 4 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Phrenic nerve neuromodulation and common Physical therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 4 sitesSpain
- Study dates
- 20 Mar 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain4 sites, 4 recruiting
- Recruiting
Centro de especialidades Morón de la Frontera
Morón de la Frontera, Seville, 41530
Antonio Jesús Morilla González, Physiotherapist, 603049432 ext. +34, amorogon@hotmail.com
- Recruiting
Centro de Salud Ronda Histórica
Seville, Sevilla, 41008
Deseada López Carballo, Dra, deseada.lopez.sspa@juntadeandalucia.es
- Recruiting
Centro de Salud las Letanías
Seville, Sevilla, 41013
Alicia Valero Sáinz, 649532242 ext. +34, aliciavalerio@hotmail.com
- Recruiting
Centro de Salud Bellavista
Seville, sevilla, 41014
María Isabel Morilla Párraga, 609582376 ext. +34, fisioaljarafe@gmail.com
About this study
Official title: 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.
Read the 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
- Shoulder Pain
- Being tested
- Phrenic nerve neuromodulation, common Physical therapy
- Keywords
- phrenic nerve, Shoulder Pain, Nuromodulation
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
common Physical therapyProcedure or surgery
the usual treatment of the center consisting of manual therapy, exercise and thermotherapy will be performed.
| Study group | Role | What they receive |
|---|---|---|
| USUAL PHYSIOTHERAPY | Active comparator | the usual treatment of the center consisting of manual therapy, exercise and thermotherapy will be performed. Receives: 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. Receives: Device: Phrenic nerve neuromodulation; Procedure: common Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-treatment, 1 week, 4 week, 12 week.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: pre-treatment, 1 week, 4 week, 12 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start20 Mar 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angel Oliva Pascual-Vaca, University of Seville
- Investigators
- Ángel Oliva Pascual-Vaca, Dr, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296979
- Sponsor's protocol ID
- 0881-N-23
- Status last verified
- Mar 2025
- First submitted
- 23 Feb 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Noninvasive Phrenic Nerve Neuromodulation in Subjects With Right Shoulder Pain and Hepatobiliary Visceral Comorbidity.
- ClinicalTrials.gov ID
- NCT06296979
- Acronym / sponsor ID
- 0881-N-23
- Conditions
- Shoulder Pain
- Keywords
- phrenic nerve, Shoulder Pain, Nuromodulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| USUAL PHYSIOTHERAPY | Active comparator | Procedure: common Physical therapythe usual treatment of the center consisting of manual therapy, exercise and thermotherapy will be performed. |
| Transcutaneous electrical nerve stimulation | Experimental | Device: Phrenic nerve neuromodulation, Procedure: common Physical therapyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phrenic nerve neuromodulationThe 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 | Transcutaneous electrical nerve stimulation |
| common Physical therapythe usual treatment of the center consisting of manual therapy, exercise and thermotherapy will be performed. | Procedure or surgery | Transcutaneous electrical nerve stimulation, USUAL PHYSIOTHERAPY |
Primary outcome
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.
4 secondary outcomes
Algometry
Time frame: pre-treatment, 1 week, 4 week, 12 week.
Goniometry passive
Time frame: pre-treatment, 1 week, 4 week, 12 week.
Quick Dash questionnaire
Time frame: pre-treatment, 1 week, 4 week, 12 week.
Goniometriy active
Time frame: pre-treatment, 1 week, 4 week, 12 week.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ángel Oliva Pascual-Vaca, Dr principal investigator
University of Seville
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phrenic nerve neuromodulation and common Physical therapy in people with Shoulder Pain, run by University of Seville at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adolfo Rosado Portillo (605663879, adolforosadoportillo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: pre-treatment, 1 week, 4 week, 12 week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.