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Effects of Intravenous Lidocaine Treatment on Sleep and Quality of Life in Fibromyalgia: An Observational Study

NCT07100665 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 51

Last updated 2026-02-06

No results posted yet for this study

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. 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.

Conditions

  • Lidocaine Infusion
  • Fibromyalgia

Sponsors & Collaborators

  • Kanuni Sultan Suleyman Training and Research Hospital

    lead OTHER

Principal Investigators

  • halil ibrahim altun, specialist · Kanuni Sultan Süleyman Training and Research Hospital

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-07-30
Completion
2025-08-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07100665 on ClinicalTrials.gov