Clinical trial NCT05994118: Physiological, Cognitive, and Personal Features in the Link Between Placebo-effect and Variability of Pain Reports
Official title: Exploring the Role of Physiological, Cognitive, and Personal Features in the Link Between Placebo-effect and Variability of Pain Reports
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Back Pain
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Western Galilee Hospital-Nahariya
First posted: 2023-08-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Subcutaneous injection of Saline solution (NACL 0.9%) in the buttock
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction of pain following placebo injection
timeFrame: Half an hour after injection
measure: Within-subjects variability of day-to-day clinical pain reports
timeFrame: 7 days before study visit
Secondary outcomes:
measure: The Focused Analgesia selection task (FAST)
timeFrame: Once, at baseline
Other outcomes:
measure: Pain modulation - Temporal Summation
timeFrame: Once, at baseline
measure: Pain modulation - Conditioned pain modulation
timeFrame: Once, at baseline
measure: Biological markers - cortisol
timeFrame: 1 day (Before and after administration of saline)
measure: Biological markers - secretory IgA
timeFrame: 1 day (Before and after administration of saline)
measure: Biological markers - oxytocin
timeFrame: 1 day (Before and after administration of saline)
measure: Autonomic measures - Heart rate variability
timeFrame: 1 day (Before and after administration of saline)
measure: Autonomic measures - blood pressure
timeFrame: 1 day (Before and after administration of saline)
measure: Short-term memory
timeFrame: Once, at baseline
measure: Pain sensitivity via QST
timeFrame: 1 day (Before and after administration of saline)
measure: Questionnaire - Optimism
timeFrame: Once, at baseline
measure: Questionnaire - pain sensitivity
timeFrame: Once, at baseline
measure: Questionnaire - interoceptive awareness
timeFrame: Once, at baseline
measure: Questionnaire - direction of attention
timeFrame: Once, at baseline
measure: Questionnaire Body awareness
timeFrame: Once, at baseline
measure: Questionnaire - suggestibility
timeFrame: Once, at baseline
measure: Questionnaire - expectations
timeFrame: Once, at baseline
measure: Questionnaire - perceived stress
timeFrame: Once, at baseline
Locations:
city: Nahariyya
country: Israel
facility: Galilee Medical center
Study officials:
affiliation: University of Haifa
name: Roi Treister, PhD
role: PRINCIPAL_INVESTIGATOR
References: