FibromyalgiaNCT05328518
Soft Tissue Tenderness and Fibromyalgia Among Schizophrenia Patients.
An observational study of Fibromyalgia and Schizophrenia, run by HaEmek Medical Center, Israel at 1 site in Israel.
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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Schizophrenia
- How many people
- 286 participants
- Where
- 1 siteIsrael
- Study dates
- 10 Jun 2021to 10 Sep 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: schizophrenic womens
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Haemek medical center
Afula, 1910500
gilat ron avraham, 0528495336, gilataavraham@gmail.com
About this study
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.
Read more
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.
- Conditions
- Fibromyalgia, Schizophrenia
- Medical subject headings
- Fibromyalgia, Schizophrenia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start10 Jun 2021
- Primary completion10 Jun 2024 (estimated)
- Study completion10 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 286 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Einat Mader, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328518
- Sponsor's protocol ID
- 0052-20 EMC
- Status last verified
- Apr 2022
- First submitted
- 14 Mar 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Tenderness and Fibromyalgia Among Schizophrenia Patients.
- ClinicalTrials.gov ID
- NCT05328518
- Acronym / sponsor ID
- 0052-20 EMC
- Conditions
- Fibromyalgia, Schizophrenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 10 Jun 2024 (estimated)
- Study completion
- 10 Sep 2024 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- schizophrenic womens
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To compare the self-reported extent by questionnarie and intensity of pain with selected tender points examination.
Time frame: 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.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Schizophrenia, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the self-reported extent by questionnarie and intensity of pain with selected tender points examination. (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.