NCT07395869

Brief Summary

In this study, it will be investigated if the phenomenon of offset analgesia, usually associated with painful heat stimulation, could also be induced using cold painful temperatures.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable pain

Timeline
32mo left

Started Feb 2026

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Feb 2026Dec 2028

First Submitted

Initial submission to the registry

February 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

February 2, 2026

Last Update Submit

February 9, 2026

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Measuring pain by computerized Visual Analog Scale Scoring

    We will ask the subjects to rate the sensation of pain on a 100

    Immediately after the intervention

Secondary Outcomes (7)

  • Pain Catastrophizing Scale (PCS).

    Baseline

  • Learned Helplessness Scale (LHS)

    Baseline

  • Depression, Anxiety, Stress Scale (DASS-21)

    Baseline

  • Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ).

    Baseline

  • Positive And Negative Affect Schedule (PANAS)

    Baseline

  • +2 more secondary outcomes

Study Arms (1)

off-set analgesia

EXPERIMENTAL

The tests of off-set analgesia will be performed using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device. Two protocols will be applied: heat off-set analgesia and cold off-set analgesia.

Other: Heat off-set analgesiaOther: Cold off-set analgesia

Interventions

Heat off-set analgesiaOTHER

The tests of off-set analgesia will be performed using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device

off-set analgesia
Cold off-set analgesiaOTHER

The tests of off-set analgesia will be performed using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device.

off-set analgesia

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women
  • years
  • Speak and understand English

You may not qualify if:

  • Pregnancy or lactation
  • Drug addiction defined as any use of cannabis, opioids, or other drugs
  • Previous or current history of neurological, immunological, musculoskeletal, cardiac disorder or psychiatric diagnoses that may affect the results (e.g., neuropathy, muscular pain in the upper extremities, anxiety, depression, schizophrenia, etc.)
  • Moles, wounds, scars, or tattoos in the area to be treated or tested
  • Current use of medications that may affect the trial such as antihistamines and pain killers
  • Skin diseases
  • Consumption of alcohol or painkillers 24 hours before the study days and between these
  • Acute or chronic pain and itch
  • Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical studies)
  • Contraindications to capsaicin, including intolerance to chili or burns or wounds at the application site (sub-project 4 only)
  • The subject is assessed as unable to engage in the necessary cooperation required by the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Neuroplasticity and Pain Faculty of Medicine, Aalborg University Selma Lagerløfs Vej 249 9260 Gistrup, Denmark

Aalborg, Aalborg, 9620, Denmark

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Silvia Lo Vecchio, PhD

CONTACT

21397785slv@hst.aau.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 2, 2026

First Posted

February 9, 2026

Study Start

February 15, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Last Updated

February 11, 2026

Record last verified: 2026-02

Locations

DK(1)