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Off-set Analgesia Induced by Cold Temperature

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07395869
Enrollment
30
Registered
2026-02-09
Start date
2026-02-15
Completion date
2028-12-31
Last updated
2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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.

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.

Interventions

OTHERHeat off-set analgesia

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

OTHERCold off-set analgesia

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

Sponsors

Aalborg University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Measuring pain by computerized Visual Analog Scale ScoringImmediately after the interventionWe will ask the subjects to rate the sensation of pain on a 100

Secondary

MeasureTime frameDescription
Pain Catastrophizing Scale (PCS).BaselineThe 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).
Learned Helplessness Scale (LHS)BaselineThe 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).
Depression, Anxiety, Stress Scale (DASS-21)BaselineThe 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"
Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ).BaselineThe RST-PQ contains in total 65 items must be answered on a Response scale: 4-point Likert (Strongly disagree → Strongly agree).
Positive And Negative Affect Schedule (PANAS)BaselineTwenty 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.
Difficulties in Emotion Regulation Scale Short Form (DERS-SF)BaselineThe 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).
Emotion Regulation Questionnaire (ERQ)BaselineThis 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).

Countries

Denmark

Contacts

CONTACTSilvia Lo Vecchio, PhD
slv@hst.aau.dk21397785

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026