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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05328518
Other study ID # 0052-20 EMC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 10, 2021
Est. completion date September 10, 2024

Study information

Verified date April 2022
Source HaEmek Medical Center, Israel
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Numerous studies reported on comorbidity of fibromyalgia and psychiatric disorders. Approximately 30% of patients with fibromyalgia have major depression at the time of diagnosis; the lifetime prevalence of depression is 74% and that of an anxiety disorder is 60%. In some fibromyalgia patients, mood and cognitive problems are much more prominent than tenderness. From the psychiatric point of view, 49% of PTSD patients and 5% of major depression patients fulfill criteria for diagnosing fibromyalgia. The association between schizophrenia and fibromyalgia is still unknown. Study hypothesis Schizophrenia patients, who have an aberrant sensation of pain, have lower prevalence of FM compared to the general population. Primary objectives 1. Demonstrate that schizophrenia patients have lower prevalence of FM, compared to the general population. 2. To compare the self-reported extent and intensity of pain with selected tender points examination.


Recruitment information / eligibility

Status Recruiting
Enrollment 286
Est. completion date September 10, 2024
Est. primary completion date June 10, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Women above 18 years of age. - Patients must meet DSM-5 criteria for a diagnosis of schizophrenia. - A stabled mental state. - If hospitalized, patients are scheduled for discharge on the basis of clinical assessment of psychiatric symptoms. Exclusion Criteria: - Mental co-morbidity. - Diagnosis of myofascial pain syndrome or chronic fatigue syndrome. - Alcohol or drug use. - Usage of any pain reliever medications during the week before recruitment.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Haemek medical center Afula

Sponsors (1)

Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary To compare the self-reported extent by questionnarie and intensity of pain with selected tender points examination. To compare the self-reported extent and intensity of pain with selected tender points examination. 1 day
Primary To compare between the degrees in pain recognition in schizophrenia patients who suffer from fibromyalgia to pain recognition in schizophrenia patients who do not suffer from fibromyalgia. To compare between the degrees in pain recognition in schizophrenia patients who suffer from fibromyalgia to pain recognition in schizophrenia patients who do not suffer from fibromyalgia. 1 day
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