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Phrenic Nerve Infiltration in Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Bupivacain
Placebo (physiological saline serum infiltration)
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring phrenic nerve, anesthesia, local, anesthetics, Pain, Bupivacaine

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Nacho Navarro FisioterapiaRecruiting
  • Asociación de Fibromialgia de LebrijaRecruiting
  • Asociación de Fibromialgia de SevillaRecruiting
  • Hospitales Universitarios Virgen del Rocío y MacarenaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Phrenic nerve anesthetics infiltration

Physiological serum infiltration

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient Global Impression of Improvement
Patient Global Impression of Improvement (PGI-Improvement) scale, ranging from 1 (very much better) to 7 (very much worse). It will be assessed verbally.
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.
Fibromyalgia Survey Questionnaire
Fibromyalgia Survey Questionnaire (Questionnaire) (parts I and III). The Fibromyalgia Survey Questionnaire will be used in the Spanish version. This questionnaire assesses the severity of fibromyalgia symptoms. The first part of this questionnaire is constituted by 3 questions related to the last week, and they have to be answered by likert scales of 3 points. Higher scores indicate higher disability. The third part of this questionnaire is constituted by a qualitative localization of pain in the last week. A higher number of body regions suffering pain constitute a worse outcome. Parts II and IV of the questionnaire will not be considered as an outcome measure since they evaluate periods of 6 months and 3 months respectively, and our post-intervention measurement will be performed just 7 days after intervention, so these parts of the questionnaire have no interest as outcome measures.
Revised Fibromyalgia Impact Questionnaire
Revised Fibromyalgia Impact Questionnaire (Questionnaire). This questionnaire evaluates the difficulty to develop certain daily-life activities. It will be used in the Spanish version. This questionnaire assesses the severity of fibromyalgia symptoms. Scores range from 0-100 with higher scores indicating higher disability.

Full Information

First Posted
March 19, 2023
Last Updated
April 3, 2023
Sponsor
University of Seville
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1. Study Identification

Unique Protocol Identification Number
NCT05792774
Brief Title
Phrenic Nerve Infiltration in Fibromyalgia
Official Title
Phrenic Afferences In Organic and Metabolic Illness: Central Sensitization - Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Fibromyalgia is a major problem due to issues such as the impact on quality of life and the associated health and social costs. It is characterized by a generalized state of sensitization, with a high level of perceived pain, among other features. Peripheral pain sources potentially exacerbate the central sensitization and its symptoms of chronic diffuse musculoskeletal pain and hyperalgesia. It has been shown that visceral pain enhances the level of central sensitization typical of the syndrome. So, it has been claimed that systematic assessment and treatment of visceral pain comorbidities should be a part of the management strategy in fibromyalgia. Patients with fibromyalgia 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. For this purpose, the investigators intend to perform a randomized clinical trial, assessing the effects on pain threshold to pressure, visual analogue scale, range of motion and fibromyalgia specific questionnaires. There will be only one intervention session. The experimental group will receive an ultrasound-guided anaesthetic infiltration of the phrenic nerve, while the control group will receive a placebo infiltration. A one-week follow-up, with intermediate measurements, will be carried out to assess the evolution of sensitization and symptomatology. The results of this study will make it possible to establish the role of phrenic afferences in fibromyalgia sensitization, thus making it possible to specify a specific therapeutic target (phrenic nerve) as well as the importance of visceral treatment in subjects with fibromyalgia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
phrenic nerve, anesthesia, local, anesthetics, Pain, Bupivacaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phrenic nerve anesthetics infiltration
Arm Type
Experimental
Arm Description
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.
Arm Title
Physiological serum infiltration
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacain
Other Intervention Name(s)
Bupivacaine B. Braun 2.5 mg/ml
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo (physiological saline serum infiltration)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Algometry
Description
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.
Time Frame
Pre-intervention. Post-intervention: 1 hour, 3 days and 7 days
Secondary Outcome Measure Information:
Title
Patient Global Impression of Improvement
Description
Patient Global Impression of Improvement (PGI-Improvement) scale, ranging from 1 (very much better) to 7 (very much worse). It will be assessed verbally.
Time Frame
Pre-intervention. Post-intervention: 1 hour, 3 hours, 6 hours, 9 hours, 24 hours, 2 days, 3 days and 7 days
Title
Numeric Pain Rating Scale
Description
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-intervention. Post-intervention: 1 hour, 3 hours, 6 hours, 9 hours, 24 hours, 2 days, 3 days and 7 days
Title
Fibromyalgia Survey Questionnaire
Description
Fibromyalgia Survey Questionnaire (Questionnaire) (parts I and III). The Fibromyalgia Survey Questionnaire will be used in the Spanish version. This questionnaire assesses the severity of fibromyalgia symptoms. The first part of this questionnaire is constituted by 3 questions related to the last week, and they have to be answered by likert scales of 3 points. Higher scores indicate higher disability. The third part of this questionnaire is constituted by a qualitative localization of pain in the last week. A higher number of body regions suffering pain constitute a worse outcome. Parts II and IV of the questionnaire will not be considered as an outcome measure since they evaluate periods of 6 months and 3 months respectively, and our post-intervention measurement will be performed just 7 days after intervention, so these parts of the questionnaire have no interest as outcome measures.
Time Frame
Pre-intervention. Post-intervention: 7 days.
Title
Revised Fibromyalgia Impact Questionnaire
Description
Revised Fibromyalgia Impact Questionnaire (Questionnaire). This questionnaire evaluates the difficulty to develop certain daily-life activities. It will be used in the Spanish version. This questionnaire assesses the severity of fibromyalgia symptoms. Scores range from 0-100 with higher scores indicating higher disability.
Time Frame
Pre-intervention. Post-intervention: 7 days.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angel Oliva Pascual-Vaca, Dr
Phone
0034 954486524
Email
angeloliva@us.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angel Oliva Pascual-Vaca, Dr
Organizational Affiliation
University of Seville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nacho Navarro Fisioterapia
City
Dos Hermanas
State/Province
Seville
ZIP/Postal Code
41089
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Navarro Carmona, MSc
Phone
0034 689712976
Facility Name
Asociación de Fibromialgia de Lebrija
City
Lebrija
State/Province
Seville
ZIP/Postal Code
41740
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesús Oliva Pascual-Vaca, PhD
Phone
0034 680841689
Facility Name
Asociación de Fibromialgia de Sevilla
City
Sevilla
State/Province
Seville
ZIP/Postal Code
41018
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Navarro Carmona, MSc
Phone
0034 689712976
Facility Name
Hospitales Universitarios Virgen del Rocío y Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Manuel López Millán
Phone
0034 616064122

12. IPD Sharing Statement

Plan to Share IPD
No

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Phrenic Nerve Infiltration in Fibromyalgia

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