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NCT Number: NCT07395869

Off-set Analgesia Induced by Cold Temperature

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Aalborg, 9620, Denmark

Location contact

Silvia Lo Vecchio, PhD

CONTACT

[email protected]

21397785 ext. 0045

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heat off-set analgesia

Other

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

Cold off-set analgesia

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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).

  2. 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).

  3. 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"

  4. 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).

  5. 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.

  6. 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).

  7. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Silvia Lo Vecchio, PhD

CONTACT

[email protected]

21397785 ext. 0045

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Feb 9, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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