Exploring the Role of Physiological, Cognitive, and Personal Features in the Link Between Placebo-effect and Variability of Pain Reports
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Back Pain
- Sponsor
- University of Haifa
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Within-subjects variability of day-to-day clinical pain reports
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Within-subjects variability of day-to-day clinical pain reports
Time Frame: 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
Reduction of pain following placebo injection
Time Frame: Half an hour after injection
The reduction in pain intensity on the 0-100 numerical rating scale (NRS) after normal saline injection
Secondary Outcomes
- The Focused Analgesia selection task (FAST)(Once, at baseline)