FibromyalgiaPhase 4NCT05792774
Phrenic Nerve Infiltration in Fibromyalgia
A Phase 4 study testing Bupivacain in people with Fibromyalgia, run by University of Seville at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Bupivacain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 4 sitesSpain
- Study dates
- 3 Apr 2023to 19 Feb 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Nacho Navarro Fisioterapia
Dos Hermanas, Seville, 41089
Asociación de Fibromialgia de Lebrija
Lebrija, Seville, 41740
Asociación de Fibromialgia de Sevilla
Seville, Seville, 41018
Hospitales Universitarios Virgen del Rocío y Macarena
Seville, 41009
About this study
Official title: Phrenic Afferences In Organic and Metabolic Illness: Central Sensitization - Fibromyalgia
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Bupivacain, Placebo (physiological saline serum infiltration)
- Keywords
- phrenic nerve, anesthesia, local, anesthetics, Pain, Bupivacaine
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
Also called Bupivacaine B. Braun 2.5 mg/ml
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo (physiological saline serum infiltration) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-intervention. Post-intervention: 1 hour, 3 days and 7 days
Secondary outcomes (4)
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.
Measured: 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
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-intervention. Post-intervention: 1 hour, 3 hours, 6 hours, 9 hours, 24 hours, 2 days, 3 days and 7 days
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.
Measured: Pre-intervention. Post-intervention: 7 days.
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.
Measured: Pre-intervention. Post-intervention: 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start3 Apr 2023
- Primary completion19 Feb 2024
- Study completion19 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
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
- Angel Oliva Pascual-Vaca, Dr, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792774
- Sponsor's protocol ID
- PAINOMICS-fibromyalgia
- Status last verified
- Feb 2024
- First submitted
- 19 Mar 2023
- Last updated
- 28 Feb 2024
- 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phrenic Afferences In Organic and Metabolic Illness: Central Sensitization - Fibromyalgia
- ClinicalTrials.gov ID
- NCT05792774
- Acronym / sponsor ID
- PAINOMICS-fibromyalgia
- Conditions
- Fibromyalgia
- Keywords
- phrenic nerve, anesthesia, local, anesthetics, Pain, Bupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 19 Feb 2024 (actual)
- Study completion
- 19 Feb 2024 (actual)
- First posted
- 31 Mar 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phrenic nerve anesthetics infiltration | Experimental | Drug: BupivacainThe 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. |
| Physiological serum infiltration | Placebo comparator | Other: Placebo (physiological saline serum infiltration)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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Other rheumatic diseases.
- Degenerative neurological disease.
- Major psychiatric disorder
- Cognitive deterioration
- Non-cooperative 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 |
|---|---|---|
| BupivacainAlso: Bupivacaine B. Braun 2.5 mg/mlThe 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 | Phrenic nerve anesthetics infiltration |
| Placebo (physiological saline serum infiltration)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 | Physiological serum infiltration |
Primary outcome
Algometry
Time frame: Pre-intervention. Post-intervention: 1 hour, 3 days and 7 days
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.
4 secondary outcomes
Patient Global Impression of Improvement
Time frame: 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
Time frame: Pre-intervention. Post-intervention: 1 hour, 3 hours, 6 hours, 9 hours, 24 hours, 2 days, 3 days and 7 days
Fibromyalgia Survey Questionnaire
Time frame: Pre-intervention. Post-intervention: 7 days.
Revised Fibromyalgia Impact Questionnaire
Time frame: Pre-intervention. Post-intervention: 7 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Fibromyalgia
Not yet recruitingObservational study
Daily Cognitive Failures and Medication Adherence in Fibromyalgia
Fibromyalgia
Not yet recruitingObservational study
Agreement Between CSI and IASP Pain Classification in Chronic Cervical Myofascial Pain
Myofascial Pain Syndrome - Neck
Not yet recruiting
Toward Biomarker-Guided Fibromyalgia Treatment With Non-Invasive Vagus Nerve Stimulation
Fibromyalgia
Active, not recruiting
Comparing Instrument-Assisted Soft Tissue Mobilization and Muscle Energy Technique for Myofascial Pain Syndrome in Women
Myofascial Pain Syndrome
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PEACE: Comparing Chronic Pain Treatment Options
Chronic Pain, Musculoskeletal Pain
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. This study is not recruiting at the moment.
Angel 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 Phase 4 study testing Bupivacain in people with Fibromyalgia, 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 28 Feb 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Algometry (time frame: Pre-intervention. Post-intervention: 1 hour, 3 days and 7 days). 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 28 Feb 2024.