Soft Tissue Tenderness and Fibromyalgia Among Schizophrenia Patients.

Schizophrenia Clinical Trial

Official title:

Soft Tissue Tenderness and Fibromyalgia Among Schizophrenia Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05328518
• Other study ID #: 0052-20 EMC
• Status: Recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Schizophrenia

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