Chronic Back Pain
Conditions
Brief 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.
Detailed 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.
Interventions
OTHERNaCl 0.9% (normal saline)
Subcutaneous normal saline injection
OTHERMagnetized Normal Saline
Magnetized Normal Saline
Sponsors
Western Galilee Hospital-Nahariya
University of Haifa
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Subcutaneous injection of Saline solution (NACL 0.9%) in the buttock
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of pain following placebo injection | Half an hour after injection | The reduction in pain intensity on the 0-100 numerical rating scale (NRS) after normal saline injection |
| Within-subjects variability of day-to-day clinical pain reports | 7 days before study visit | The variance of within person pain scores reported on a 0-100 Visual Analog Scale VAS during 7 days via pain-dairy at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Focused Analgesia selection task (FAST) | Once, at baseline | Experimental paradigm which allow calculation of within-subjects variability of pain reports in response to thermal stimuli |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain modulation - Conditioned pain modulation | Once, at baseline | Change in pain intensity on the 0-100 numerical rating scale (NRS) in response to concurrent noxious stimuli |
| Biological markers - cortisol | 1 day (Before and after administration of saline) | Saliva cortisol levels |
| Biological markers - secretory IgA | 1 day (Before and after administration of saline) | Saliva secretory IgA level |
| Biological markers - oxytocin | 1 day (Before and after administration of saline) | Saliva oxytocin level |
| Autonomic measures - Heart rate variability | 1 day (Before and after administration of saline) | As measured by a monitor |
| Autonomic measures - blood pressure | 1 day (Before and after administration of saline) | As measured by a monitor |
| Short-term memory | Once, at baseline | via the Digit Span test |
| Questionnaire - perceived stress | Once, at baseline | via the perceived stress scale |
| Questionnaire - Optimism | Once, at baseline | Via the life orientation test revised (LOT-R) |
| Questionnaire - pain sensitivity | Once, at baseline | Via the pain sensitivity questionnaire (PSQ) |
| Questionnaire - interoceptive awareness | Once, at baseline | Via the Multidimensional assessment of interoceptive awareness (MAIA questionnaire) |
| Questionnaire - direction of attention | Once, at baseline | Via the Self consciousness scale revised |
| Questionnaire Body awareness | Once, at baseline | via the body awareness Questionnaire (BAQ) |
| Questionnaire - suggestibility | Once, at baseline | Via the short suggestibility scale (SSS) |
| Pain sensitivity via QST | 1 day (Before and after administration of saline) | Mechanical pain thresholds |
| Questionnaire - expectations | Once, at baseline | via the expect Questionnaire |
| Pain modulation - Temporal Summation | Once, at baseline | Change in pain intensity on the 0-100 numerical rating scale (NRS) in response to the first and last electrical noxious stimuli |
Countries
Israel
Contacts
Primary ContactRoi Treister, PhD
Outcome results
None listed