Soft Tissue Tenderness and Fibromyalgia Among Schizophrenia Patients.

Recruiting

• Conditions: Schizophrenia; Fibromyalgia

• Registration Number: NCT05328518
• Lead Sponsor: HaEmek Medical Center, Israel

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

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

Not available

Study Timeline

• Study Start: 2021-06-10
• Study First Submitted: 2022-03-14
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-07
• Last Update Submitted: 2022-04-07
• Study First Posted: 2022-04-14
• Last Update Posted: 2022-04-14
• Primary Completion: 2024-06-10
• Study Completion: 2024-09-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 286

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Haemek medical center; 🇮🇱 Afula, Israel