Off-set Analgesia Induced by Cold Temperature
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Heat off-set analgesia, Cold off-set analgesia.
- Who it may be relevant to
- Registry conditions: Pain. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pain and Itch Neuromodulation: Effects of Offset Analgesia, Placebo, and Nocebo and Topographical Distribution of Itch and Pain Receptors
Overview
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
- 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.
Primary outcome measures
- Measuring pain by computerized Visual Analog Scale Scoring [Time frame: Immediately after the intervention]
Secondary outcome measures (7)
- Pain Catastrophizing Scale (PCS). [Time frame: Baseline]
- Learned Helplessness Scale (LHS) [Time frame: Baseline]
- Depression, Anxiety, Stress Scale (DASS-21) [Time frame: Baseline]
- Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ). [Time frame: Baseline]
- Positive And Negative Affect Schedule (PANAS) [Time frame: Baseline]
- Difficulties in Emotion Regulation Scale Short Form (DERS-SF) [Time frame: Baseline]
- Emotion Regulation Questionnaire (ERQ) [Time frame: Baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Denmark · 1 center
- Center for Neuroplasticity and Pain Faculty of Medicine, Aalborg University Selma Lagerløf — Aalborg
Identifiers
NCT: NCT07395869 · N-20250017 Project 1