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

ConditionShoulder Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Seville

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

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

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: USUAL PHYSIOTHERAPYActive comparator 1 intervention
Group B: Transcutaneous electrical nerve stimulationExperimental treatment 2 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
pre-treatment, 1 week, 4 week, 12 week.
2

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.

Time frame
pre-treatment, 1 week, 4 week, 12 week.
3

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.

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

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.

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

Other outcomes

Sponsors and contacts

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