Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 8:37 PM
Study NCT ID:
NCT07395869
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-11
First Post:
2026-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Off-set Analgesia Induced by Cold Temperature
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-02-02', 'studyFirstSubmitQcDate': '2026-02-02', 'lastUpdatePostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measuring pain by computerized Visual Analog Scale Scoring', 'timeFrame': 'Immediately after the intervention', 'description': 'We will ask the subjects to rate the sensation of pain on a 100'}], 'secondaryOutcomes': [{'measure': 'Pain Catastrophizing Scale (PCS).', 'timeFrame': 'Baseline', 'description': '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).'}, {'measure': 'Learned Helplessness Scale (LHS)', 'timeFrame': 'Baseline', 'description': "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)."}, {'measure': 'Depression, Anxiety, Stress Scale (DASS-21)', 'timeFrame': 'Baseline', 'description': '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"'}, {'measure': 'Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ).', 'timeFrame': 'Baseline', 'description': 'The RST-PQ contains in total 65 items must be answered on a Response scale: 4-point Likert (Strongly disagree → Strongly agree).'}, {'measure': 'Positive And Negative Affect Schedule (PANAS)', 'timeFrame': 'Baseline', 'description': "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."}, {'measure': 'Difficulties in Emotion Regulation Scale Short Form (DERS-SF)', 'timeFrame': 'Baseline', 'description': '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).'}, {'measure': 'Emotion Regulation Questionnaire (ERQ)', 'timeFrame': 'Baseline', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women\n* 18-60 years\n* Speak and understand English\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Drug addiction defined as any use of cannabis, opioids, or other drugs\n* 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.)\n* Moles, wounds, scars, or tattoos in the area to be treated or tested\n* Current use of medications that may affect the trial such as antihistamines and pain killers\n* Skin diseases\n* Consumption of alcohol or painkillers 24 hours before the study days and between these\n* Acute or chronic pain and itch\n* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical studies)\n* Contraindications to capsaicin, including intolerance to chili or burns or wounds at the application site (sub-project 4 only)\n* The subject is assessed as unable to engage in the necessary cooperation required by the study'}, 'identificationModule': {'nctId': 'NCT07395869', 'briefTitle': 'Off-set Analgesia Induced by Cold Temperature', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University'}, 'officialTitle': 'Pain and Itch Neuromodulation: Effects of Offset Analgesia, Placebo, and Nocebo and Topographical Distribution of Itch and Pain Receptors', 'orgStudyIdInfo': {'id': 'N-20250017 Project 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'off-set analgesia', 'description': '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.', 'interventionNames': ['Other: Heat off-set analgesia', 'Other: Cold off-set analgesia']}], 'interventions': [{'name': 'Heat off-set analgesia', 'type': 'OTHER', 'description': 'The tests of off-set analgesia will be performed using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device', 'armGroupLabels': ['off-set analgesia']}, {'name': 'Cold off-set analgesia', 'type': 'OTHER', 'description': 'The tests of off-set analgesia will be performed using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device.', 'armGroupLabels': ['off-set analgesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9620', 'city': 'Aalborg', 'state': 'Aalborg', 'country': 'Denmark', 'contacts': [{'name': 'Silvia Lo Vecchio, PhD', 'role': 'CONTACT', 'email': 'slv@hst.aau.dk', 'phone': '21397785', 'phoneExt': '0045'}], 'facility': 'Center for Neuroplasticity and Pain Faculty of Medicine, Aalborg University Selma Lagerløfs Vej 249 9260 Gistrup, Denmark', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'centralContacts': [{'name': 'Silvia Lo Vecchio, PhD', 'role': 'CONTACT', 'email': 'slv@hst.aau.dk', 'phone': '21397785', 'phoneExt': '0045'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Silvia Lo Vecchio', 'investigatorAffiliation': 'Aalborg University'}}}}