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

Not Applicable

Recruiting

• Conditions: Chronic Back Pain
• Interventions: Other: Magnetized Normal Saline; Other: NaCl 0.9% (normal saline)

• Registration Number: NCT05994118
• Lead Sponsor: University of Haifa

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.

Study Timeline

• Study Start: 2021-03-21
• Study First Submitted: 2022-04-13
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-15
• Last Update Submitted: 2023-08-15
• Study First Posted: 2023-08-16
• Last Update Posted: 2023-08-16
• Primary Completion: 2023-09
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Magnetized Normal Saline	Magnetized Normal Saline	0.5 milliliter of magnetized NACL 0.9% subcutaneous saline injection
Normal Saline	NaCl 0.9% (normal saline)	0.5 milliliter of NACL 0.9% subcutaneous saline injection

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Galilee Medical center; 🇮🇱 Nahariyya, Israel