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

University of Haifa

Status: Enrolling

Conditions: Chronic Back Pain

Treatments: Other: Magnetized Normal Saline; Other: NaCl 0.9% (normal saline)

Study type: Interventional

Funder types: Other

Identifiers

NCT05994118

0044-20-NHR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Normal Saline

Placebo Comparator group

Description:

0.5 milliliter of NACL 0.9% subcutaneous saline injection

Treatment:

Other: NaCl 0.9% (normal saline)

Magnetized Normal Saline

Active Comparator group

Description:

0.5 milliliter of magnetized NACL 0.9% subcutaneous saline injection

Treatment:

Other: Magnetized Normal Saline