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

Last updated: August 15, 2023
Sponsor: University of Haifa
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Back Pain

Chronic Pain

Chronic Musculoskeletal Pain

Treatment

Magnetized Normal Saline

NaCl 0.9% (normal saline)

Clinical Study ID

NCT05994118
0044-20-NHR
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ormore on a 0-10 NRS

Exclusion

Exclusion Criteria:

  • Mental retardation or cognitive impairment
  • Pregnancy or breast-feeding
  • Malignancy and a diagnosis of malignant disease

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Magnetized Normal Saline
Phase:
Study Start date:
March 21, 2021
Estimated Completion Date:
March 31, 2024

Study 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.

Connect with a study center

  • Galilee Medical center

    Nahariyya, 2210001
    Israel

    Active - Recruiting

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