Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-28 @ 1:31 PM
Study NCT ID:
NCT05730166
Status:
COMPLETED
Last Update Posted:
2023-05-12
First Post:
2023-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Inhibitory Effects of Other Pain Induced by Mechanical Pressure at Different Intensities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-11', 'studyFirstSubmitDate': '2023-02-06', 'studyFirstSubmitQcDate': '2023-02-14', 'lastUpdatePostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Tibialis Anterior Pressure Pain Threshold (PPT) to immediate post-conditioning stimulus', 'timeFrame': 'At baseline and immediately after the conditioning stimulus', 'description': 'PPTs will be assessed on the dominant side over the tibialis anterior muscle using a digital algometer (Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say "stop" when the pressure sensation becomes painful.The average of 3 assessments on the tibialis anterior of the dominant side will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Conditioned Pain Modulation', 'Manual Therapy', 'Physiotherapy', 'Physical therapy'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective is to estimate the effects on pain thresholds of a painful mechanical stimulus on the upper trapezius at moderate intensity compared to mild intensity or non-painful.', 'detailedDescription': 'The mechanical stimulus produced in manual therapy (MT) techniques elicits neurophysiological responses within the peripheral and central nervous system responsible for pain inhibition. Almost all types of MT elicit a neurophysiological response that is associated with the descending pain modulation circuit. But it has not been demonstrated whether this inhibition occurs through a conditioned pain modulation mechanism induced by painful mechanical stimulation that is carried out with manual therapy techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy male or female between 18 and 65 years\n* Free of pain and with no history of chronic pain\n\nExclusion Criteria:\n\n* Pregnant or having given birth within the last year'}, 'identificationModule': {'nctId': 'NCT05730166', 'briefTitle': 'Pain Inhibitory Effects of Other Pain Induced by Mechanical Pressure at Different Intensities', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Rey Juan Carlos'}, 'officialTitle': 'Conditioned Pain Modulation Induced by Mechanical Stimulation. A Mechanism of Manual Therapy Analgesia: Study 2', 'orgStudyIdInfo': {'id': 'MechCPM2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mechanical stimulation at moderate pain intensity', 'description': 'Mechanical compression is applied with the thumb to the upper trapezius muscle on the non-dominant side at the midpoint between the acromion and C7. The intensity of this will be regulated by the pain it causes the patient, trying to ensure that it is at all times approximately 5/10 on the numerical pain rating scale (NPRS) with 0 being "no pain at all" and 10 being "the worst pain imaginable". The stimulation will be carried out for 2 minutes.', 'interventionNames': ['Other: Mechanical Conditioning stimulus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mechanical stimulation at mild pain intensity', 'description': 'Mechanical compression is applied with the thumb to the upper trapezius muscle on the non-dominant side at the midpoint between the acromion and C7. The intensity of this will be regulated by the pain it causes the patient, trying to ensure that it is at all times approximately 2/10 on the numerical pain rating scale (NPRS) with 0 being "no pain at all" and 10 being "the worst pain imaginable". The stimulation will be carried out for 2 minutes.', 'interventionNames': ['Other: Mechanical Conditioning stimulus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Painless mechanical stimulation', 'description': 'Mechanical compression is applied with the thumb to the upper trapezius muscle on the non-dominant side at the midpoint between the acromion and C7. The intensity of this will be regulated by the pain it causes the patient, trying to ensure that it is at all times approximately 0/10 on the numerical pain rating scale (NPRS) with 0 being "no pain at all" and 10 being "the worst pain imaginable". The stimulation will be carried out for 2 minutes.', 'interventionNames': ['Other: Mechanical Conditioning stimulus']}], 'interventions': [{'name': 'Mechanical Conditioning stimulus', 'type': 'OTHER', 'description': 'Mechanical stimulus on the upper trapezius of the non-dominant side.', 'armGroupLabels': ['Mechanical stimulation at mild pain intensity', 'Mechanical stimulation at moderate pain intensity', 'Painless mechanical stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28047', 'city': 'Alcorcón', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Universidad Rey Juan Carlos', 'geoPoint': {'lat': 40.34582, 'lon': -3.82487}}], 'overallOfficials': [{'name': 'Josué Fernández Carnero, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Rey Juan Carlos'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Josue Fernandez Carnero', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Josue Fernandez Carnero', 'investigatorAffiliation': 'Universidad Rey Juan Carlos'}}}}