Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2026-02-20 @ 10:10 PM
Study NCT ID:
NCT04108403
Status:
COMPLETED
Last Update Posted:
2022-09-16
First Post:
2019-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanisms of Massage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will be masked to the type of instructional set received during the intervention. However, participants will be notified of this upon completion of the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-15', 'studyFirstSubmitDate': '2019-09-26', 'studyFirstSubmitQcDate': '2019-09-26', 'lastUpdatePostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pressure Pain Threshold', 'timeFrame': '1 hour', 'description': 'A computerized pressure algometer with a 1cm diameter rubber tip will be applied to the web space of the non-dominant foot. Participants are instructed to say "stop" so the stimulus can be terminated when the sensation first transitions from pressure to pain (threshold).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Pain']}, 'referencesModule': {'references': [{'pmid': '36069038', 'type': 'DERIVED', 'citation': 'Wilson AT, Bishop MD, Beneciuk JM, Tilley HE, Riley JL 3rd, Cruz-Almeida Y, Bialosky JE. Expectations affect pain sensitivity changes during massage. J Man Manip Ther. 2023 Apr;31(2):84-92. doi: 10.1080/10669817.2022.2118449. Epub 2022 Sep 7.'}]}, 'descriptionModule': {'briefSummary': 'The investigators have previously found moderately painful massage produces comparable changes in pain sensitivity as a conditioned pain modulation paradigm in healthy participants suggesting shared underlying mechanisms. The researchers aim to extend these findings by understanding the influence of expectation on these findings.', 'detailedDescription': 'Massage is a muscle biased intervention individuals seek for pain alleviation; however, the mechanisms of massage are not well established. In this study, the investigators aim to determine the effect of expectations on massage related hypoalgesia. Individuals meeting eligibility criteria and agreeing to participate will attend one session that lasts approximately one hour. A myofascial trigger point (taut band of muscle tissue) will be assessed on the neck of the participant. Next, a baseline assessment of pressure pain threshold will be performed followed by random assignment to one of four study arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pain Free\n\nExclusion Criteria:\n\n* non-English speaking\n* systemic medical condition known to affect sensation (i.e. diabetes)\n* regular use of prescription pain medication to manage pain\n* current or history of chronic pain condition\n* currently using blood thinning medication\n* any blood clotting disorder such as hemophilia'}, 'identificationModule': {'nctId': 'NCT04108403', 'briefTitle': 'Mechanisms of Massage', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Mechanisms of Massage', 'orgStudyIdInfo': {'id': 'IRB201902417'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pain Inducing Massage and Positive Expectation Instructions', 'description': 'A myofascial trigger point will be assessed in the trapezius muscle and massage applied to this area of the neck. Participants in this arm will receive a positive expectation instructional set followed by a moderately painful massage (pain = 50/100). Massage will be applied for one minute, four times with assessment of pressure pain threshold at the foot between each interval.', 'interventionNames': ['Other: Pain Inducing Massage', 'Other: Positive Expectation Instructional Set']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pain Inducing Massage and Negative Expectation Instructions', 'description': 'A myofascial trigger point will be assessed in the trapezius muscle and massage applied to this area of the neck. Participants in this arm will receive a negative expectation instructional set followed by a moderately painful massage (pain = 50/100). Massage will be applied for one minute, four times with assessment of pressure pain threshold at the foot between each interval.', 'interventionNames': ['Other: Pain Inducing Massage', 'Other: Negative Expectation Instructional Set']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pain Free Massage and Positive Expectation Instructions', 'description': 'A myofascial trigger point will be assessed in the trapezius muscle and massage applied to this area of the neck. Participants in this arm will receive a positive expectation instructional set followed by a pain free massage (pain = 0/100). Massage will be applied for one minute, four times with assessment of pressure pain threshold at the foot between each interval.', 'interventionNames': ['Other: Pain Free Massage', 'Other: Positive Expectation Instructional Set']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pain Free Massage and Negative Expectation Instructions', 'description': 'A myofascial trigger point will be assessed in the trapezius muscle and massage applied to this area of the neck. Participants in this arm will receive a negative expectation instructional set followed by a pain free massage (pain = 0/100). Massage will be applied for one minute, four times with assessment of pressure pain threshold at the foot between each interval.', 'interventionNames': ['Other: Pain Free Massage', 'Other: Negative Expectation Instructional Set']}], 'interventions': [{'name': 'Pain Inducing Massage', 'type': 'OTHER', 'description': 'A pain inducing massage (pain intensity = 50/100) will be applied for 60 seconds, 4 times.', 'armGroupLabels': ['Pain Inducing Massage and Negative Expectation Instructions', 'Pain Inducing Massage and Positive Expectation Instructions']}, {'name': 'Pain Free Massage', 'type': 'OTHER', 'description': 'A pain free massage (pain intensity = 0/100) will be applied for 60 seconds, 4 times.', 'armGroupLabels': ['Pain Free Massage and Negative Expectation Instructions', 'Pain Free Massage and Positive Expectation Instructions']}, {'name': 'Positive Expectation Instructional Set', 'type': 'OTHER', 'description': 'Participants will be instructed that the massage is effective for some people with neck pain.', 'armGroupLabels': ['Pain Free Massage and Positive Expectation Instructions', 'Pain Inducing Massage and Positive Expectation Instructions']}, {'name': 'Negative Expectation Instructional Set', 'type': 'OTHER', 'description': 'Participants will be instructed that the massage is ineffective for some people with neck pain.', 'armGroupLabels': ['Pain Free Massage and Negative Expectation Instructions', 'Pain Inducing Massage and Negative Expectation Instructions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Joel Bialosky, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}