Physiological, Cognitive, and Personal Features in the Link Between Placebo-effect and Variability of Pain Reports

Exploring the Role of Physiological, Cognitive, and Personal Features in the Link Between Placebo-effect and Variability of Pain Reports

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Back Pain
• Intervention / Treatment: Other: NaCl 0.9% (normal saline); Other: Magnetized Normal Saline

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roi Treister, PhD; Phone Number: 0533839935; Email: rtreister@univ.haifa.ac.il

Study Locations

• Israel
  • Nahariyya, Israel, 2210001
    • Recruiting
    • Galilee Medical Center
    • Contact: Adi Shani, MA; Phone Number: +972-524239112; Email: a.eilat888@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Normal Saline; 0.5 milliliter of NACL 0.9% subcutaneous saline injection	Other: NaCl 0.9% (normal saline); Subcutaneous normal saline injection
Active Comparator: Magnetized Normal Saline; 0.5 milliliter of magnetized NACL 0.9% subcutaneous saline injection	Other: Magnetized Normal Saline; Magnetized Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Haifa
• Collaborators: Western Galilee Hospital-Nahariya
• Investigators: Principal Investigator: Roi Treister, PhD, University of Haifa

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2021
• Primary Completion (Estimated): September 1, 2023
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: 0044-20-NHR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Once published, the data (without any personal identification) will be available upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No