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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-21

Study Completion Date

2024-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Subcutaneous injection of Saline solution (NACL 0.9%) in the buttock

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Normal Saline

0.5 milliliter of NACL 0.9% subcutaneous saline injection

Group Type PLACEBO_COMPARATOR

NaCl 0.9% (normal saline)

Intervention Type OTHER

Subcutaneous normal saline injection

Magnetized Normal Saline

0.5 milliliter of magnetized NACL 0.9% subcutaneous saline injection

Group Type ACTIVE_COMPARATOR

Magnetized Normal Saline

Intervention Type OTHER

Magnetized Normal Saline

Interventions

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NaCl 0.9% (normal saline)

Subcutaneous normal saline injection

Intervention Type OTHER

Magnetized Normal Saline

Intervention Type OTHER

Eligibility Criteria

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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