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IV lidocaine shows promise for fibromyalgia sleep troubles

NCT ID NCT07100665

Symptom relief Sponsor: Kanuni Sultan Suleyman Training and Research Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how intravenous lidocaine affects sleep and quality of life in 51 people with fibromyalgia who still had pain and sleep problems despite other treatments. Researchers measured pain, sleep quality, and overall impact of the condition. The goal was to see if this treatment could help with symptoms that are hard to manage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lidocaine (intravenous)
What this could lead to
If it works, this could point toward a new way to ease sleep problems and improve daily life for people with fibromyalgia.
What could go wrong
This is a small, completed observational study with no control group, so results are preliminary. It does not prove IV lidocaine is better than other treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

51 people

The number who actually took part.

Started

Jul 2025

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

fibromyalgia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fibromyalgia Lidocaine infusion

Contacts and locations

Locations

  • İKanuni Sultan Süleyman Training and Research Hospital

    Küçükçekmece, Istanbul, (507) 277-4773, Turkey (Türkiye)

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