Pain RecognitionNCT05345548
Sensitivity, Threshold, Tolerance and Pain Recognition in Schizophrenia Patients and Their Relatives.
A study testing Cold Pressor test in people with Pain Recognition and Schizophrenia, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain Recognition, Schizophrenia
- What is being tested?
- Cold Pressor test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 29 Aug 2019to 15 Jan 2024
- Phase
- Interventional
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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
Official title: Sensitivity, Threshold, Tolerance and Pain Recognition in Schizophrenia Patients and Their Relatives
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.
Read more
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.
- Conditions
- Pain Recognition, Schizophrenia
- Being tested
- Cold Pressor test
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Pressor testDiagnostic test
Cold Pressor test will be done for 3 minute duration maximum
| Study group | Role | What they receive |
|---|---|---|
| Cold Pressor test | Experimental | Not described Receives: Diagnostic Test: Cold Pressor test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start29 Aug 2019
- Primary completion29 Dec 2023 (estimated)
- Study completion15 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain RecognitionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
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
- Investigators
- Einat Mader, MD, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345548
- Sponsor's protocol ID
- 0041-19-EMC
- Status last verified
- Apr 2022
- First submitted
- 14 Mar 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity, Threshold, Tolerance and Pain Recognition in Schizophrenia Patients and Their Relatives
- ClinicalTrials.gov ID
- NCT05345548
- Acronym / sponsor ID
- 0041-19-EMC
- Conditions
- Pain Recognition, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- 29 Dec 2023 (estimated)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 26 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cold Pressor test | Experimental | Diagnostic Test: Cold Pressor test |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold Pressor testCold Pressor test will be done for 3 minute duration maximum | Diagnostic test | Cold Pressor test |
Primary outcome
Schizophrenia patients and their biological relatives who have an aberrant sensation of pain also have a reduced capability to evaluate their own pain.
Time frame: 20 minutes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Einat Mader, MD principal investigator
haemek medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Pressor test in people with Pain Recognition 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 26 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?
Contact gilat ron avraham, mph (0528495336, gilataavraham@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Schizophrenia patients and their biological relatives who have an aberrant sensation of pain also have a reduced capability to evaluate their own pain. (time frame: 20 minutes). 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 26 Apr 2022.