Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT06981260
Status:
COMPLETED
Last Update Posted:
2025-05-20
First Post:
2025-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of Sound in Enhancing or Disabling the Placebo Effect of a Deactivated Transcutaneous Electrical Nerve Stimulator (TENS) Device on Hypoalgesia in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participant and assessor blinded'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A healthy volunteer pilot study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2016-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2025-05-07', 'studyFirstSubmitQcDate': '2025-05-19', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain pressure threshold (PPT) at L2 (lumbar spine) from baseline to post-intervention.', 'timeFrame': 'From Baseliine to 5 minutes', 'description': 'Change in pain pressure threshold (PPT) at L2 (2nd lumbar vertebra) from baseline to post-intervention. Measured using pressure algometer (Wagner Force Dial FDK/FDN Series).'}], 'secondaryOutcomes': [{'measure': 'Effect of gender on placebo response', 'timeFrame': 'From Baseliine to 5 minutes', 'description': 'Effect of gender on placebo response (ANOVA analysis on post-treatment PPT)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Placebo responses are now recognized for their clinical and physiological significance. Non-pharmacological cues such as sound may enhance or induce these responses. This trial aims to assess the effect of sound on the placebo-induced hypoalgesia elicited by a deactivated TENS device in healthy individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No history of TENS use\n\nExclusion Criteria:\n\n* Current medication use\n* Orthopedic, neurological, or systemic conditions\n* Pregnancy (current and planned)'}, 'identificationModule': {'nctId': 'NCT06981260', 'briefTitle': 'The Role of Sound in Enhancing or Disabling the Placebo Effect of a Deactivated Transcutaneous Electrical Nerve Stimulator (TENS) Device on Hypoalgesia in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Health and Resilience'}, 'officialTitle': 'The Role of Sound in Enhancing or Disabling the Placebo Effect of a Deactivated Transcutaneous Electrical Nerve Stimulator (TENS) Device on Hypoalgesia in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'SOUNDPLACEBO-2016-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: Placebo with sound', 'description': 'Deactivated transcutaneous electrical nerve stimulation (TENS) with beeping sound (15-second interval)', 'interventionNames': ['Procedure: Group A Deactivated TENS with beeping sound (15-second interval)']}, {'type': 'EXPERIMENTAL', 'label': 'Group B: Placebo with no sound', 'description': 'Group B: Deactivated transcutaneous electrical nerve stimulation (TENS) without sound', 'interventionNames': ['Procedure: Group B']}], 'interventions': [{'name': 'Group A Deactivated TENS with beeping sound (15-second interval)', 'type': 'PROCEDURE', 'description': 'Deactivated TENS with beeping sound (15-second interval)', 'armGroupLabels': ['Group A: Placebo with sound']}, {'name': 'Group B', 'type': 'PROCEDURE', 'description': 'Deactivated TENS without sound', 'armGroupLabels': ['Group B: Placebo with no sound']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Health and Resilience', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aegean College, Athens, Greece', 'class': 'UNKNOWN'}, {'name': 'Coventry University, United Kingdom', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}