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| Name | Class |
|---|---|
| Western Galilee Hospital-Nahariya | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Saline | Placebo Comparator | 0.5 milliliter of NACL 0.9% subcutaneous saline injection |
|
| Magnetized Normal Saline | Active Comparator | 0.5 milliliter of magnetized NACL 0.9% subcutaneous saline injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NaCl 0.9% (normal saline) | Other | Subcutaneous normal saline injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pain modulation - Conditioned pain modulation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roi Treister, PhD | Contact | 0533839935 | rtreister@univ.haifa.ac.il |
| Name | Affiliation | Role |
|---|---|---|
| Roi Treister, PhD | University of Haifa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galilee Medical center | Recruiting | Nahariya | 2210001 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41871484 | Derived | Shani A, Ghanayim R, Granot M, Rahamimov N, Treister R. Associations between placebo-responses across models and time: Exploratory analysis of a sham randomized clinical trial in chronic-back-pain patients. J Psychosom Res. 2026 Jul;206:112645. doi: 10.1016/j.jpsychores.2026.112645. Epub 2026 Mar 19. |
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Once published, the data (without any personal identification) will be available upon request
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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Subcutaneous injection of Saline solution (NACL 0.9%) in the buttock
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| Magnetized Normal Saline |
| Other |
Magnetized Normal Saline |
|
Change in pain intensity on the 0-100 numerical rating scale (NRS) in response to concurrent noxious stimuli
| Once, at baseline |
| Biological markers - cortisol | Saliva cortisol levels | 1 day (Before and after administration of saline) |
| Biological markers - secretory IgA | Saliva secretory IgA level | 1 day (Before and after administration of saline) |
| Biological markers - oxytocin | Saliva oxytocin level | 1 day (Before and after administration of saline) |
| Autonomic measures - Heart rate variability | As measured by a monitor | 1 day (Before and after administration of saline) |
| Autonomic measures - blood pressure | As measured by a monitor | 1 day (Before and after administration of saline) |
| Short-term memory | via the Digit Span test | Once, at baseline |
| Pain sensitivity via QST | Mechanical pain thresholds | 1 day (Before and after administration of saline) |
| Questionnaire - Optimism | Via the life orientation test revised (LOT-R) | Once, at baseline |
| Questionnaire - pain sensitivity | Via the pain sensitivity questionnaire (PSQ) | Once, at baseline |
| Questionnaire - interoceptive awareness | Via the Multidimensional assessment of interoceptive awareness (MAIA questionnaire) | Once, at baseline |
| Questionnaire - direction of attention | Via the Self consciousness scale revised | Once, at baseline |
| Questionnaire Body awareness | via the body awareness Questionnaire (BAQ) | Once, at baseline |
| Questionnaire - suggestibility | Via the short suggestibility scale (SSS) | Once, at baseline |
| Questionnaire - expectations | via the expect Questionnaire | Once, at baseline |
| Questionnaire - perceived stress | via the perceived stress scale | Once, at baseline |