Soft Tissue Tenderness and Fibromyalgia Among Schizophrenia Patients.

Sponsor

HaEmek Medical Center, Israel (Other)

Overall Status

Recruiting

CT.gov ID

NCT05328518

Collaborator

(none)

286

Enrollment

Location

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Demonstrate that schizophrenia patients have lower prevalence of FM, compared to the general population.
To compare the self-reported extent and intensity of pain with selected tender points examination.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia Schizophrenia

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

286 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Soft Tissue Tenderness and Fibromyalgia Among Schizophrenia Patients.

Actual Study Start Date :

Jun 10, 2021

Anticipated Primary Completion Date :

Jun 10, 2024

Anticipated Study Completion Date :

Sep 10, 2024

Outcome Measures

Primary Outcome Measures

To compare the self-reported extent by questionnarie and intensity of pain with selected tender points examination. [1 day]
To compare the self-reported extent and intensity of pain with selected tender points examination.
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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Haemek medical center	Afula		Israel	1910500

Sponsors and Collaborators

HaEmek Medical Center, Israel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Einat Mader, pricipal investigator, HaEmek Medical Center, Israel

ClinicalTrials.gov Identifier:

NCT05328518

Other Study ID Numbers:

0052-20 EMC

First Posted:

Apr 14, 2022

Last Update Posted:

Apr 14, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fibromyalgia

Myofascial Pain Syndromes

Schizophrenia

Study Results

No Results Posted as of Apr 14, 2022