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

NCT05994118 | Unknown

• 1 other identifier: 0044-20-NHR
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Back Pain

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• The Focused Analgesia selection task (FAST)

  Once, at baseline

Other Outcomes (17)

• Pain modulation - Temporal Summation

  Once, at baseline

• Pain modulation - Conditioned pain modulation

  Once, at baseline

• Biological markers - cortisol

  1 day (Before and after administration of saline)

Study Arms (2)

Normal Saline

PLACEBO COMPARATOR

0.5 milliliter of NACL 0.9% subcutaneous saline injection

Other: NaCl 0.9% (normal saline)

Magnetized Normal Saline

ACTIVE COMPARATOR

0.5 milliliter of magnetized NACL 0.9% subcutaneous saline injection

Other: Magnetized Normal Saline

Interventions

NaCl 0.9% (normal saline) OTHER

Subcutaneous normal saline injection

Normal Saline

Magnetized Normal Saline OTHER

Magnetized Normal Saline

Magnetized Normal Saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Haifa: lead
• Western Galilee Hospital-Nahariya: collaborator

Study Sites (1)

Galilee Medical center

Nahariya, 2210001, Israel

RECRUITING

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Roi Treister, PhD

  University of Haifa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roi Treister, PhD

CONTACT

0533839935; rtreister@univ.haifa.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: August 16, 2023
• Study Start: March 21, 2021
• Primary Completion: September 1, 2023
• Study Completion: March 1, 2024
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share

Locations

IL (1)