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

Chronic Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05994118
• Other study ID #: 0044-20-NHR
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2021
• Est. completion date: March 2024

Study information

• Verified date: August 2023
• Source: University of Haifa
• Contact: Roi Treister, PhD
• Phone: 0533839935
• Email: rtreister[@]univ.haifa.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Back Pain

Intervention

Other:
• NaCl 0.9% (normal saline)
Subcutaneous normal saline injection
• Magnetized Normal Saline
Magnetized Normal Saline

Locations

Country	Name	City	State
Israel	Galilee Medical center	Nahariyya

Sponsors (2)

Lead Sponsor	Collaborator
University of Haifa	Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Biological markers - cortisol	Saliva cortisol levels	1 day (Before and after administration of saline)
Other	Biological markers - secretory IgA	Saliva secretory IgA level	1 day (Before and after administration of saline)
Other	Biological markers - oxytocin	Saliva oxytocin level	1 day (Before and after administration of saline)
Other	Autonomic measures - Heart rate variability	As measured by a monitor	1 day (Before and after administration of saline)
Other	Autonomic measures - blood pressure	As measured by a monitor	1 day (Before and after administration of saline)
Other	Short-term memory	via the Digit Span test	Once, at baseline
Other	Pain sensitivity via QST	Mechanical pain thresholds	1 day (Before and after administration of saline)
Other	Questionnaire - Optimism	Via the life orientation test revised (LOT-R)	Once, at baseline
Other	Questionnaire - pain sensitivity	Via the pain sensitivity questionnaire (PSQ)	Once, at baseline
Other	Questionnaire - interoceptive awareness	Via the Multidimensional assessment of interoceptive awareness (MAIA questionnaire)	Once, at baseline
Other	Questionnaire - direction of attention	Via the Self consciousness scale revised	Once, at baseline
Other	Questionnaire Body awareness	via the body awareness Questionnaire (BAQ)	Once, at baseline
Other	Questionnaire - suggestibility	Via the short suggestibility scale (SSS)	Once, at baseline
Other	Questionnaire - expectations	via the expect Questionnaire	Once, at baseline
Other	Questionnaire - perceived stress	via the perceived stress scale	Once, at baseline
Primary	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
Primary	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	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