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Sensitivity, Threshold, Tolerance and Pain Recognition in Schizophrenia Patients and Their Relatives.

Primary Purpose

Pain Recognition, Schizophrenia

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Cold Pressor test
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pain Recognition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients must meet DSM-5 criteria for a diagnosis of schizophrenia.
  2. Patients above 18 years of age.
  3. Sufficient knowledge of the Hebrew language
  4. A stabled mental state. If hospitalized, patients are scheduled for discharge on the basis of clinical assessment of psychiatric symptoms.

Exclusion Criteria:

  1. Mental co-morbidity.
  2. Peripheral neuropathies, upper limb trauma, chronic pain conditions.
  3. Alcohol or drug use.
  4. Usage of any pain reliever medications during the week before recruitment.

Sites / Locations

  • Haemek medical centerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cold Pressor test

Arm Description

Outcomes

Primary Outcome Measures

Schizophrenia patients and their biological relatives who have an aberrant sensation of pain also have a reduced capability to evaluate their own pain.
severity of pain insensitivity in schizophrenia patients is correlated to the degree of their ability to assess their own pain in different imaginary situations.using pain sensitivity questionnaire & cold pressor test

Secondary Outcome Measures

Full Information

First Posted
March 14, 2022
Last Updated
April 25, 2022
Sponsor
HaEmek Medical Center, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT05345548
Brief Title
Sensitivity, Threshold, Tolerance and Pain Recognition in Schizophrenia Patients and Their Relatives.
Official Title
Sensitivity, Threshold, Tolerance and Pain Recognition in Schizophrenia Patients and Their Relatives
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 29, 2019 (Actual)
Primary Completion Date
December 29, 2023 (Anticipated)
Study Completion Date
January 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
It has been known that schizophrenia patients have a reduced ability to recognize both their own pain and the pain of others. The patients' pain judgement is not correlated with their affective or cognitive empathic capacities. These results suggest that changes in pain recognition in schizophrenia patients reflect specific dysfunctions in pain processing . Schizophrenia patients have a reduced ability to recognize both their own pain. This deficit is not related to their empathic capacities . The correlation between pain perception in schizophrenia patients and their ability to evaluate their own pain is still unknown. Pain insensitivity to pressure has been described in the context of schizophrenic illness was also evident in the biological relatives of those with the disorder. It is still unclear whether relatives of schizophrenia patients have aberrations in assessing their own pain in different imaginary situations. Animal models are important tools in the study of psychiatric disorders and the mechanism of action of antipsychotic and other psychiatric drugs. Positive symptoms of schizophrenia are difficult to model in rodents, but locomotor hyperactivity in response to a novel environment were reported as correlated with positive symptoms . On the other hand, negative symptoms such as social interaction and anhedonia and cognitive processing (e.g. emotional memory, sensorimotor gating, and associative learning) can be investigated in animal models with a high degree of validity . Furthermore, in most schizophrenia-like animal models, both first and second-generation antipsychotic drugs are reported to be effective in ameliorating behavioral abnormalities. It is well establish that patients with schizophrenia have been shown to display decreased sensitivity to pain, and antipsychotics are used to treat chronic pain. For example, chronic administration of phencyclidine or ketamine, psychomimetic drugs, produces decreased sensitivity to mechanical stimulation, and increased pain tolerance. The classic antipsychotic drug fluphenazine has anti-allodynic properties in multiple rodent models of nerve injury-induced neuropathic pain. An analgesic effect of quetiapine in the Cancer-induced bone pain animal model have been demonstrated. However, the mechanism of action to relive pain is still under debate and may differ between different agents. Animal models of acute and chronic pain allow evaluating the effects of analgesics drugs and other components on pain sensation and transmission, and underlining their molecular mechanism. Usually, these tests rely on an escape behavior or a withdrawal reflex as an index of pain. One known method of measuring responses to thermal stimuli involves application of a noxious thermal stimulus (hot or cold). This method has been used in order to investigate new analgesic components. Study hypothesis Schizophrenia patients and their biological relatives who have an aberrant sensation of pain also have a reduced capability to evaluate their own pain. Primary objectives Demonstrate that schizophrenia patients who suffer from pain insensitivity also have a reduced capability to evaluate their own pain, compared to population without a mental illness. Prove that the severity of pain insensitivity in schizophrenia patients is correlated to the degree of their ability to assess their own pain in different imaginary situations. Secondary objective Demonstrate that healthy biological relatives of schizophrenia patients have aberrations in assessing their own pain. Find the correlation between pain insensitivity in schizophrenia patients to pain insensitivity in their relatives. Find the correlation between the degrees in pain recognition in schizophrenia patients to pain recognition in their biological relatives. Investigate the impact of anti-psychotic drugs on pain threshold of schizophrenia patients. Study design This study is a prospective cross-sectional trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Recognition, Schizophrenia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cold Pressor test
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Cold Pressor test
Intervention Description
Cold Pressor test will be done for 3 minute duration maximum
Primary Outcome Measure Information:
Title
Schizophrenia patients and their biological relatives who have an aberrant sensation of pain also have a reduced capability to evaluate their own pain.
Description
severity of pain insensitivity in schizophrenia patients is correlated to the degree of their ability to assess their own pain in different imaginary situations.using pain sensitivity questionnaire & cold pressor test
Time Frame
20 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients must meet DSM-5 criteria for a diagnosis of schizophrenia. Patients above 18 years of age. Sufficient knowledge of the Hebrew language 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. Peripheral neuropathies, upper limb trauma, chronic pain conditions. Alcohol or drug use. Usage of any pain reliever medications during the week before recruitment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
gilat ron avraham, mph
Phone
0528495336
Email
gilataavraham@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Einat Mader, MD
Organizational Affiliation
haemek medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haemek medical center
City
Afula
ZIP/Postal Code
1910500
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
gilat ron avraham
Phone
0528495336
Email
gilataavraham@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Sensitivity, Threshold, Tolerance and Pain Recognition in Schizophrenia Patients and Their Relatives.

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