Off-set Analgesia Induced by Cold Temperature

February 9, 2026 updated by: Silvia Lo Vecchio, Aalborg University

Pain and Itch Neuromodulation: Effects of Offset Analgesia, Placebo, and Nocebo and Topographical Distribution of Itch and Pain Receptors

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

After filling some questionnaires, two areas (4x4 cm, 4 cm apart) will be selected on each forearm of the subjects. The areas will be randomly treated with one of the following trials: hot experimental trial, hot control trial, cold experimental trial, and cold control trial.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Silvia Lo Vecchio, PhD
  • Phone Number: 0045 21397785
  • Email: slv@hst.aau.dk

Study Locations

  • Denmark
    • Aalborg
      • Aalborg, Aalborg, Denmark, 9620
        • Center for Neuroplasticity and Pain Faculty of Medicine, Aalborg University Selma Lagerløfs Vej 249 9260 Gistrup, Denmark
        • Contact:
          • Silvia Lo Vecchio, PhD
          • Phone Number: 0045 21397785
          • Email: slv@hst.aau.dk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy men and women
  • 18-60 years
  • Speak and understand English

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: off-set analgesia
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 analgesia
The tests of off-set analgesia will be performed using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device
Other: Cold off-set analgesia
The tests of off-set analgesia will be performed using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring pain by computerized Visual Analog Scale Scoring
Time Frame: Immediately after the intervention
We will ask the subjects to rate the sensation of pain on a 100
Immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Catastrophizing Scale (PCS).
Time Frame: Baseline
The PCS assesses negative and exaggerated coping concerning anticipated or experienced painful stimuli. Thirteen items have to be answered on a 5-point Likert-type scale ranging from 0 (Not at all) to 4 (all the time).
Baseline
Depression, Anxiety, Stress Scale (DASS-21)
Time Frame: Baseline
The questionnaire measures the magnitude of depression, anxiety, and stress. Each of these three subscales consists of 7 questions answered using a 0-3 Likert scale, with 0 meaning "it did not apply to me", and 3 meaning "it applied to me very much"
Baseline
Difficulties in Emotion Regulation Scale Short Form (DERS-SF)
Time Frame: Baseline
The questionnaire is an 18-item measure used to identify emotional regulation issues in adults. Participants rate each item on a 5-point Likert scale (from 1 to 5).
Baseline
Emotion Regulation Questionnaire (ERQ)
Time Frame: Baseline
This questionnaire is designed to assess individual differences in the habitual use of two emotion regulation strategies: cognitive reappraisal and expressive suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree), where 4 means (neutral).
Baseline
Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ).
Time Frame: Baseline
The RST-PQ contains in total 65 items must be answered on a Response scale: 4-point Likert (Strongly disagree → Strongly agree).
Baseline
Positive And Negative Affect Schedule (PANAS)
Time Frame: Baseline
Twenty words are associated with the subject's current feelings and have to be rated on a 5-points Likert-type scale from: Very slightly or not at all to extremely.
Baseline
Learned Helplessness Scale (LHS)
Time Frame: Baseline
The questionnaire consists of 20 items, and the participant's response to each item is rated on a 4-point Likert scale branging from strongly agree (1) to strongly disagree (4).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

February 2, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20250017 Project 1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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