Soft Tissue Tenderness and Fibromyalgia Among Schizophrenia Patients.

NCT ID: NCT05328518

Last Updated: 2022-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

286 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-10

Study Completion Date

2024-09-10

Brief Summary

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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.

Detailed Description

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Conditions

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Fibromyalgia Schizophrenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Einat Mader

pricipal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Haemek medical center

Afula, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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gilat ron avraham

Role: primary

0528495336

Other Identifiers

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0052-20 EMC

Identifier Type: -

Identifier Source: org_study_id

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