Phrenic Nerve Infiltration in Fibromyalgia

NCT05792774 | Completed Phase 4

• 1 other identifier: PAINOMICS-fibromyalgia
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

It is known that nociceptive afferences in visceral pain and visceral disorders increase sensitization in subjects suffering from fibromyalgia. These patients use to present visceral comorbidities. Those comorbidities include that of peridiaphragmatic organs, which are supplied by the phrenic nerve among other innervations. It is known that peridiaphragmatic organs trigger referred pain in the neck area, via the phrenic nerves. So, the phrenic nociceptive afferences can be contributing to enhance the state of sensitization in fibromyalgia. This study aims to analyze the ability of phrenic nerve infiltration to diminish sensitization in subjects suffering fibromyalgia, by means of a randomized controlled trial.

Conditions

Fibromyalgia

Keywords

phrenic nerve; anesthesia, local; anesthetics; Pain; Bupivacaine

Outcome Measures

Primary Outcomes (1)

• Algometry

  Pressure pain threshold in the specific 18 tender points in fibromyalgia. PPT levels defined as the minimum necessary pressure to evoke pain will be evaluated using a handheld electronic pressure algometer. Change from baseline in algometry.

  Pre-intervention. Post-intervention: 1 hour, 3 days and 7 days

Secondary Outcomes (4)

• Patient Global Impression of Improvement

  Pre-intervention. Post-intervention: 1 hour, 3 hours, 6 hours, 9 hours, 24 hours, 2 days, 3 days and 7 days

• Numeric Pain Rating Scale

  Pre-intervention. Post-intervention: 1 hour, 3 hours, 6 hours, 9 hours, 24 hours, 2 days, 3 days and 7 days

• Fibromyalgia Survey Questionnaire

  Pre-intervention. Post-intervention: 7 days.

• Revised Fibromyalgia Impact Questionnaire

  Pre-intervention. Post-intervention: 7 days.

Study Arms (2)

Phrenic nerve anesthetics infiltration

EXPERIMENTAL

The experimental intervention will consist of ultrasound-guided anesthetic blockade of the phrenic nerve at the laterocervical supraclavicular level with 1 ml of lidocaine without vasoconstrictor 2% to infiltrate the skin and 3ml of bupivacaine without vasoconstrictor 0.25% for neural blockade, making the local anesthetic surround the nerve between the anterior scalene muscle and the sternocleidomastoid muscle.

Drug: Bupivacain

Physiological serum infiltration

PLACEBO COMPARATOR

The placebo intervention will be similar in relation to 2% lidocaine without vasoconstrictor for the skin, but an ultrasound-guided puncture will be performed at the level of the subcutaneous cellular tissue by injecting 3 ml of physiological saline.

Other: Placebo (physiological saline serum infiltration)

Interventions

Bupivacain DRUG

The experimental intervention will consist of ultrasound-guided anesthetic blockade of the phrenic nerve at the laterocervical supraclavicular level with 1 ml of lidocaine without vasoconstrictor 2% to infiltrate the skin and 3ml of bupivacaine without vasoconstrictor 0.25% for neural blockade, making the local anesthetic surround the nerve between the anterior scalene muscle and the sternocleidomastoid muscle.

Also known as: Bupivacaine B. Braun 2.5 mg/ml

Phrenic nerve anesthetics infiltration

Placebo (physiological saline serum infiltration) OTHER

The placebo intervention will be similar in relation to 2% lidocaine without vasoconstrictor for the skin, but an ultrasound-guided puncture will be performed at the level of the subcutaneous cellular tissue by injecting 3 ml of physiological saline.

Physiological serum infiltration

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women
• Over 18 and under 64 years old
• Diagnosis of Fibromyalgia
• Any peridiaphragmatic visceral disorder diagnosed by the respective specialist.
• That the subject agrees to participate in the project by signing the informed consent.

You may not qualify if:

• Other rheumatic diseases.
• Degenerative neurological disease.
• Major psychiatric disorder
• Cognitive deterioration
• Non-cooperative subject
• Any medical condition affecting sensory evaluation
• Contraindication to infiltration of the phrenic nerve.

Sponsors & Collaborators

• University of Seville: lead

Study Sites (4)

Nacho Navarro Fisioterapia

Dos Hermanas, Seville, 41089, Spain

Location

Asociación de Fibromialgia de Lebrija

Lebrija, Seville, 41740, Spain

Location

Asociación de Fibromialgia de Sevilla

Seville, Seville, 41018, Spain

Location

Hospitales Universitarios Virgen del Rocío y Macarena

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Angel Oliva Pascual-Vaca, Dr

  University of Seville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 19, 2023
• First Posted: March 31, 2023
• Study Start: April 3, 2023
• Primary Completion: February 19, 2024
• Study Completion: February 19, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)