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

NCT07100665 | Completed

• 1 other identifier: Fibromyalgia, sleep quality
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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).

  3 months

Secondary Outcomes (1)

• Fibromyalgia impact questionnaire (FIQ)

  3 months

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

İKanuni Sultan Süleyman Training and Research Hospital

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

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• halil ibrahim altun, specialist

  Kanuni Sultan Süleyman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pain specialist

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: August 3, 2025
• Study Start: July 1, 2025
• Primary Completion: July 30, 2025
• Study Completion: August 15, 2025
• Last Updated: February 6, 2026

Record last verified: 2025-09

Locations

TU (1)