Lidocaine InfusionpainNCT07100665
Effects of Intravenous Lidocaine Treatment on Sleep and Quality of Life in Fibromyalgia: An Observational Study
An observational study of Lidocaine Infusion and Fibromyalgia, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Fibromyalgia (FM) is a psychosocial disorder characterized by widespread body pain, sleep disturbances, morning stiffness, and fatigue, impairing patients' quality of life. It is more common in middle-aged women, but its prevalence is 2% in the general population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lidocaine Infusion, Fibromyalgia
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 15 Aug 2025
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Fifty-two patients aged 18-65 years who were treated with IV lidocaine and met the ACR (American College of Rheumatology) 2016 FM diagnostic criteria and had ongoing complaints despite pharmacological and non-pharmacological FM treatments (Numeric Rating Scale >5) and accompanied by sleep disturbance (Pittsburgh Sleep Quality Index score >5) between June 2023 and June 2024 were evaluated retrospectively.
Inclusion Criteria:Patients with sleep disturbances (Pittsburgh Sleep Quality Index score >5),
- who continued to have complaints despite pharmacological and non-pharmacological treatments for FM (Numeric Rating Scale >4),
- who met the ACR (American College of Rheumatology) 2016 FM diagnostic criteria,
- and who received IV lidocaine treatment,
Exclusion Criteria:-Patients whose medical treatment was changed during follow-up related to FM, those with metabolic diseases (chronic renal and hepatic failure, spondyloarthropathies, uncontrolled diabetes and hypertension, hypo/hyperthyroidism, etc.),
- patients with abnormal serum electrolyte levels, those taking magnesium or vitamin D supplements, pregnant women,
- patients with known allergy to the administered drug, those with malignancy or active infection, patients with neuromuscular disease and psychosis,
- patients with known cardiac arrhythmia and decompensated heart disease, -patients whose IV lidocaine treatment could not be completed,
- patients whose data were not available and who did not accept treatment were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İKanuni Sultan Süleyman Training and Research Hospital
Küçükçekmece, Istanbul, (507) 277-4773
About this study
Fibromyalgia (FM) is a psychosocial disorder characterized by widespread body pain, sleep disturbances, morning stiffness, and fatigue, impairing patients' quality of life. It is more common in middle-aged women, but its prevalence is 2% in the general population. Genetic factors, peripheral and central sensitization, autonomic nervous system dysfunction, and hypothalamic-pituitary axis dysregulation are thought to play important roles in its pathophysiology. In FM patients, decreased levels of norepinephrine, dopamine, serotonin, and some other neurotransmitters in the central nervous system and cerebrospinal fluid have been observed .
Complaints in FM patients vary considerably. The pain often begins localized and progresses to widespread body pain. Physical examination frequently reveals allodynia and hyperalgesia. Irritable bowel syndrome, depression, primary headaches, restless leg syndrome, Reynoud phenomenon, dry mouth, palpitations, allergic conditions, sexual dysfunction, dysmenorrhea, chronic fatigue syndrome, and anxiety disorder may accompany the condition. While these diagnoses are also considered in the differential diagnosis, their presence does not exclude the diagnosis of FM. The 2016 revised American College of Rheumatology (ACR) criteria are frequently used for diagnosis.
Read more
A multimodal approach is applied to treatment. These approaches include lifestyle changes, exercise, meditation, balneotherapy, yoga, psychotherapies, medical, and interventional methods. Antidepressants are often preferred for medical treatment. Patients' noncompliance with medication and side effects contribute to medical treatment failure. Acupuncture, dry needling, trigger point injections, and some complementary medicine methods are interventional methods .
In recent years, particularly in chronic pain management, intravenous (IV) methods are thought to reduce both peripheral and central sensitization. Intravenous drug therapies for chronic pain have been reported to be beneficial in addition to medical and interventional treatments. Magnesium, lidocaine, and ketamine are frequently administered IV treatments. There are various recommendations regarding the frequency and dosage of these medications, but a consensus has not yet emerged. IV lidocaine has been used in FM patients in recent years, although the number of studies reported is limited .
The symptom severity and pain prevalence in FM patients vary from patient to patient. Therefore, the treatment approach should be individualized. Sleep and quality of life disturbances frequently accompany FM and exacerbate other symptoms .
To our knowledge, IV lidocaine treatment is considered beneficial in FM patients, but we have not found any studies in the literature on its effectiveness on sleep and quality of life. In this study, we aimed to present the effects of IV lidocaine, a less frequently administered but well-established treatment method in FM, a challenging disease.
Read the detailed description
In this study, after obtaining approval from the clinical research ethics committee (Health Sciences University Istanbul Kanuni Sultan Süleyman Training and Research Hospital, KAEK/2024.10.212), 51 patients aged 18-65 years who were treated with IV lidocaine and met the ACR (American College of Rheumatology) 2016 FM diagnostic criteria with accompanying sleep disturbance (Pittsburgh Sleep Quality Index score >5) and persistent complaints despite pharmacological and non-pharmacological FM treatments (Numeric Rating Scala >4) were retrospectively evaluated between June 2023 and June 2024 .. The study was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all patients in the study, which was conducted in a tertiary pain clinic in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline. Patient information was recorded: age, gender, body mass index, duration of symptoms, antineuropathic medical treatments, side effects observed during treatment, and pre- and post-treatment scores from the Fibromyalgia Impact Questionnaire (FIQ) at 4 and 12 weeks, the NRS-11 (Numeric Rating Scale), the Short Form-12 (SF-12) subcomponents of the Mental Component Scale-12 (MBS-12) and Physical Component Scale-12 (FBS-12), and the Pittsburgh Sleep Quality Index (PSQI).
Procedure The patient was taken to the procedure room, monitored (5-lead electrocardiogram (ECG), pulse oximetry, and blood pressure), and intravenous access was established in the forearm. Before IV lidocaine was administered, a 12-lead ECG was obtained and evaluated for dysrhythmia by a cardiologist with at least 10 years of experience. The patients were informed about possible side effects such as dizziness, vertigo, nausea and vomiting, numbness of the tongue, palpitations, a metallic taste in the mouth, and dry mouth. Patients were administered a 120-minute IV lidocaine infusion with 500 cc of 0.9% saline solution under appropriate monitoring conditions. Patients were monitored for 2 hours after the infusion. Patients received 5 mg/kg IV lidocaine twice weekly, 3 days apart, in accordance with current literature. The patients' FIQ, NRS-11, SF-12, and PSQI scores were recorded before and after treatment, 4 and 12 weeks.
Assessment Scales The FIQ is a 10-item scale ranging from 0 to 100, with each question rated on a 0 to 10 scale. Higher scores indicate increased disease activity (11). The NRS-11 is an 11-point numerical scale that allows patients to rate their pain on a scale from 0 (no pain at all) to 10 (the most severe pain they have ever experienced) .
The SF-12 consists of 12 questions: two questions on physical role, two on physical functioning, one on bodily pain, one on general health, one on energy, one on social functioning, two on emotional role, and two on mental health. The subcomponents of the SF-12, the FQI-12 and MQI-12, both have scores ranging from 0 to 100, with higher scores representing better health .
The PSQI is an index in which patients self-report their sleep quality and disturbances over a 1-month period. This index, consisting of 19 questions and 7 subheadings, is scored on a scale of 0-21, with 0 being the best and 3 being the worst. Higher scores indicate worse sleep quality and disturbances .
- Conditions
- Lidocaine Infusion, Fibromyalgia
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Effects of Intravenous Lidocaine Treatment on Sleep and Quality of Life in Fibromyalgia: | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS-11 (Numeric Rating Scale):It is an 11-point numerical scale on which patients can rate their pain from 0 (no pain at all) to 10 (the most severe pain they have ever felt).
Measured: 3 months
Secondary outcomes (1)
Fibromyalgia impact questionnaire (FIQ)
The FIQ is a 10-item scale with scores ranging from 0 to 100, with each question rated on a scale of 0 to 10. A higher score indicates increased disease activity.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Jul 2025
- Primary completion30 Jul 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lidocaine InfusionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil Ibrahim Altun, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- halil ibrahim altun, specialist, Principal investigator, Kanuni Sultan Süleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100665
- Sponsor's protocol ID
- Fibromyalgia, sleep quality
- Acronym
- pain
- Status last verified
- Sep 2025
- First submitted
- 27 Jul 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intravenous Lidocaine Treatment on Sleep and Quality of Life in Fibromyalgia: An Observational Study
- ClinicalTrials.gov ID
- NCT07100665
- Acronym / sponsor ID
- pain / Fibromyalgia, sleep quality
- Conditions
- Lidocaine Infusion, Fibromyalgia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 3 Aug 2025 (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.
Fibromyalgia (FM) is a psychosocial disorder characterized by widespread body pain, sleep disturbances, morning stiffness, and fatigue, impairing patients' quality of life. It is more common in middle-aged women, but its prevalence is 2% in the general population. Genetic factors, peripheral and central sensitization, autonomic nervous system dysfunction, and hypothalamic-pituitary axis dysregulation are thought to play important roles in its pathophysiology. In FM patients, decreased levels of norepinephrine, dopamine, serotonin, and some other neurotransmitters in the central nervous system and cerebrospinal fluid have been observed .
Complaints in FM patients vary considerably. The pain often begins localized and progresses to widespread body pain. Physical examination frequently reveals allodynia and hyperalgesia. Irritable bowel syndrome, depression, primary headaches, restless leg syndrome, Reynoud phenomenon, dry mouth, palpitations, allergic conditions, sexual dysfunction, dysmenorrhea, chronic fatigue syndrome, and anxiety disorder may accompany the condition. While these diagnoses are also considered in the differential diagnosis, their presence does not exclude the diagnosis of FM. The 2016 revised American College of Rheumatology (ACR) criteria are frequently used for diagnosis.
A multimodal approach is applied to treatment. These approaches include lifestyle changes, exercise, meditation, balneotherapy, yoga, psychotherapies, medical, and interventional methods. Antidepressants are often preferred for medical treatment. Patients' noncompliance with medication and side effects contribute to medical treatment failure. Acupuncture, dry needling, trigger point injections, and some complementary medicine methods are interventional methods .
In recent years, particularly in chronic pain management, intravenous (IV) methods are thought to reduce both peripheral and central sensitization. Intravenous drug therapies for chronic pain have been reported to be beneficial in addition to medical and interventional treatments. Magnesium, lidocaine, and ketamine are frequently administered IV treatments. There are various recommendations regarding the frequency and dosage of these medications, but a consensus has not yet emerged. IV lidocaine has been used in FM patients in recent years, although the number of studies reported is limited .
The symptom severity and pain prevalence in FM patients vary from patient to patient. Therefore, the treatment approach should be individualized. Sleep and quality of life disturbances frequently accompany FM and exacerbate other symptoms .
To our knowledge, IV lidocaine treatment is considered beneficial in FM patients, but we have not found any studies in the literature on its effectiveness on sleep and quality of life. In this study, we aimed to present the effects of IV lidocaine, a less frequently administered but well-established treatment method in FM, a challenging disease.
Detailed description
In this study, after obtaining approval from the clinical research ethics committee (Health Sciences University Istanbul Kanuni Sultan Süleyman Training and Research Hospital, KAEK/2024.10.212), 51 patients aged 18-65 years who were treated with IV lidocaine and met the ACR (American College of Rheumatology) 2016 FM diagnostic criteria with accompanying sleep disturbance (Pittsburgh Sleep Quality Index score >5) and persistent complaints despite pharmacological and non-pharmacological FM treatments (Numeric Rating Scala >4) were retrospectively evaluated between June 2023 and June 2024 .. The study was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all patients in the study, which was conducted in a tertiary pain clinic in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline. Patient information was recorded: age, gender, body mass index, duration of symptoms, antineuropathic medical treatments, side effects observed during treatment, and pre- and post-treatment scores from the Fibromyalgia Impact Questionnaire (FIQ) at 4 and 12 weeks, the NRS-11 (Numeric Rating Scale), the Short Form-12 (SF-12) subcomponents of the Mental Component Scale-12 (MBS-12) and Physical Component Scale-12 (FBS-12), and the Pittsburgh Sleep Quality Index (PSQI).
Procedure The patient was taken to the procedure room, monitored (5-lead electrocardiogram (ECG), pulse oximetry, and blood pressure), and intravenous access was established in the forearm. Before IV lidocaine was administered, a 12-lead ECG was obtained and evaluated for dysrhythmia by a cardiologist with at least 10 years of experience. The patients were informed about possible side effects such as dizziness, vertigo, nausea and vomiting, numbness of the tongue, palpitations, a metallic taste in the mouth, and dry mouth. Patients were administered a 120-minute IV lidocaine infusion with 500 cc of 0.9% saline solution under appropriate monitoring conditions. Patients were monitored for 2 hours after the infusion. Patients received 5 mg/kg IV lidocaine twice weekly, 3 days apart, in accordance with current literature. The patients' FIQ, NRS-11, SF-12, and PSQI scores were recorded before and after treatment, 4 and 12 weeks.
Assessment Scales The FIQ is a 10-item scale ranging from 0 to 100, with each question rated on a 0 to 10 scale. Higher scores indicate increased disease activity (11). The NRS-11 is an 11-point numerical scale that allows patients to rate their pain on a scale from 0 (no pain at all) to 10 (the most severe pain they have ever experienced) .
The SF-12 consists of 12 questions: two questions on physical role, two on physical functioning, one on bodily pain, one on general health, one on energy, one on social functioning, two on emotional role, and two on mental health. The subcomponents of the SF-12, the FQI-12 and MQI-12, both have scores ranging from 0 to 100, with higher scores representing better health .
The PSQI is an index in which patients self-report their sleep quality and disturbances over a 1-month period. This index, consisting of 19 questions and 7 subheadings, is scored on a scale of 0-21, with 0 being the best and 3 being the worst. Higher scores indicate worse sleep quality and disturbances .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effects of Intravenous Lidocaine Treatment on Sleep and Quality of Life in Fibromyalgia: | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Fifty-two patients aged 18-65 years who were treated with IV lidocaine and met the ACR (American College of Rheumatology) 2016 FM diagnostic criteria and had ongoing complaints despite pharmacological and non-pharmacological FM treatments (Numeric Rating Scale >5) and accompanied by sleep disturbance (Pittsburgh Sleep Quality Index score >5) between June 2023 and June 2024 were evaluated retrospectively.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NRS-11 (Numeric Rating Scale):It is an 11-point numerical scale on which patients can rate their pain from 0 (no pain at all) to 10 (the most severe pain they have ever felt).
Time frame: 3 months
1 secondary outcome
Fibromyalgia impact questionnaire (FIQ)
Time frame: 3 months
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 6 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
halil ibrahim altun, specialist principal investigator
Kanuni Sultan Süleyman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lidocaine Infusion and Fibromyalgia, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
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?
NRS-11 (Numeric Rating Scale):It is an 11-point numerical scale on which patients can rate their pain from 0 (no pain at all) to 10 (the most severe pain they have ever felt). (time frame: 3 months). 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 6 Feb 2026.