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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05994118
Other study ID # 0044-20-NHR
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 21, 2021
Est. completion date March 2024

Study information

Verified date August 2023
Source University of Haifa
Contact Roi Treister, PhD
Phone 0533839935
Email rtreister@univ.haifa.ac.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study attempt to identify whether and how factors known or considered to be related with analgesic placebo effect or variability of pain reports separately, may contribute to their coupling. Among these factors - personal traits such as optimism, focus of attention, suggestibility, and short-term memory along with characteristics of stress and relaxation. Additionally, the role of pain sensitivity and the individual's pain modulation profile in the relationship between analgesic placebo effect and variability of pain reports will be examined.


Description:

Data will be collected from 130 patients with non-specific chronic back pain that will be recruited for a prospective cross-sectional study. To characterize the main study variables, the participants will undergo the Focused analgesia selection test (FAST) which evaluates within-subjects variability of pain reports, and placebo manipulation containing administration of an inert injection accompanied by a verbal suggestion, which is expected to produce placebo effects. The involvement of additional factors considered associated with the within-subjects variability of pain reports and the placebo response will be explored. Stress and well-being characteristics will be examined by measuring cortisol levels in saliva and in hair, salivary level of Secretory Immune globulin A (SIgA), and an autonomic nervous system function and a stress perception questionnaire. Personal traits such as suggestibility, optimism, and Focus of attention, will be examined using questionnaires. Memory will be assessed by memory task, and factors related to the pain modulation system will be examined using psychophysical tests, and a pain sensitivity questionnaire.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date March 2024
Est. primary completion date September 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Literate adults - Aged 18 - 80 years - A diagnosis of chronic back pain - Sufferings from back pain during the last 3 months or more, with an intensity of 3 or more on a 0-10 NRS Exclusion Criteria: - Mental retardation or cognitive impairment - Pregnancy or breast-feeding - Malignancy and a diagnosis of malignant disease

Study Design


Related Conditions & MeSH terms


Intervention

Other:
NaCl 0.9% (normal saline)
Subcutaneous normal saline injection
Magnetized Normal Saline
Magnetized Normal Saline

Locations

Country Name City State
Israel Galilee Medical center Nahariyya

Sponsors (2)

Lead Sponsor Collaborator
University of Haifa Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Other Pain modulation - Temporal Summation Change in pain intensity on the 0-100 numerical rating scale (NRS) in response to the first and last electrical noxious stimuli Once, at baseline
Other Pain modulation - Conditioned pain modulation Change in pain intensity on the 0-100 numerical rating scale (NRS) in response to concurrent noxious stimuli Once, at baseline
Other Biological markers - cortisol Saliva cortisol levels 1 day (Before and after administration of saline)
Other Biological markers - secretory IgA Saliva secretory IgA level 1 day (Before and after administration of saline)
Other Biological markers - oxytocin Saliva oxytocin level 1 day (Before and after administration of saline)
Other Autonomic measures - Heart rate variability As measured by a monitor 1 day (Before and after administration of saline)
Other Autonomic measures - blood pressure As measured by a monitor 1 day (Before and after administration of saline)
Other Short-term memory via the Digit Span test Once, at baseline
Other Pain sensitivity via QST Mechanical pain thresholds 1 day (Before and after administration of saline)
Other Questionnaire - Optimism Via the life orientation test revised (LOT-R) Once, at baseline
Other Questionnaire - pain sensitivity Via the pain sensitivity questionnaire (PSQ) Once, at baseline
Other Questionnaire - interoceptive awareness Via the Multidimensional assessment of interoceptive awareness (MAIA questionnaire) Once, at baseline
Other Questionnaire - direction of attention Via the Self consciousness scale revised Once, at baseline
Other Questionnaire Body awareness via the body awareness Questionnaire (BAQ) Once, at baseline
Other Questionnaire - suggestibility Via the short suggestibility scale (SSS) Once, at baseline
Other Questionnaire - expectations via the expect Questionnaire Once, at baseline
Other Questionnaire - perceived stress via the perceived stress scale Once, at baseline
Primary Reduction of pain following placebo injection The reduction in pain intensity on the 0-100 numerical rating scale (NRS) after normal saline injection Half an hour after injection
Primary Within-subjects variability of day-to-day clinical pain reports The variance of within person pain scores reported on a 0-100 Visual Analog Scale VAS during 7 days via pain-dairy at baseline 7 days before study visit
Secondary The Focused Analgesia selection task (FAST) Experimental paradigm which allow calculation of within-subjects variability of pain reports in response to thermal stimuli Once, at baseline
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