Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:03 PM
Study NCT ID:
NCT05826834
Status:
UNKNOWN
Last Update Posted:
2023-07-03
First Post:
2023-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Investigation of Ball Rolling Effects on Trigger Points
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-29', 'studyFirstSubmitDate': '2023-03-23', 'studyFirstSubmitQcDate': '2023-04-21', 'lastUpdatePostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Range of Motion before ball rolling', 'timeFrame': '3 minutes before the intervention (Ball-rolling)', 'description': 'the range of motion in the shoulder joint'}, {'measure': 'Pain pressure threshold before ball rolling', 'timeFrame': '3 minutes before the intervention (Ball-rolling)', 'description': "the measurement of the pain pressure threshold on the trapezius muscle using Lafayette Muscle Tester; A hand-held algometer will be applied on the participant's skin and an incremental pressure will be applied until the participant notify the experimenter to stop. The pain pressure threshold will be reported in kilogram/cm2."}, {'measure': 'Range of Motion after ball rolling', 'timeFrame': 'up to 3 minutes after the intervention (Ball-rolling)', 'description': 'the range of motion in the shoulder joint'}, {'measure': 'Pain pressure threshold after ball rolling', 'timeFrame': 'up to 3 minutes after the intervention (Ball-rolling)', 'description': "the measurement of the pain pressure threshold on the trapezius muscle using Lafayette Muscle Tester; A hand-held algometer will be applied on the participant's skin and an incremental pressure will be applied until the participant notify the experimenter to stop. The pain pressure threshold will be reported in kilogram/cm2."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trigger Point Pain, Myofascial']}, 'descriptionModule': {'briefSummary': 'The current study aims to examine the potential effects of rolling a Myostorm ball on the trigger points in the upper back muscles.', 'detailedDescription': 'The investigators will ask the participants to attend the laboratory in two sessions. They will seek the tender spots on the trapezius muscle. Then the participants will be asked to roll a Myostorm ball ( a small hard ball made of plastic with a layer of soft material cover) on their affected muscles. They will be tested for pain-pressure threshold (PPT), shoulder range of motion, electromyography (EMG), and force before and after the manipulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* trigger points on the trapezius muscle\n\nExclusion Criteria:\n\n* back injury'}, 'identificationModule': {'nctId': 'NCT05826834', 'briefTitle': 'An Investigation of Ball Rolling Effects on Trigger Points', 'organization': {'class': 'OTHER', 'fullName': 'Memorial University of Newfoundland'}, 'officialTitle': 'An Investigation of Ball Rolling Effects on Trigger Points', 'orgStudyIdInfo': {'id': '20211162'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ball rolling', 'description': 'The ball-rolling group will be asked to roll the ball on the trapezius muscle.', 'interventionNames': ['Device: ball-rolling (Myostorm ball)']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The control group with no intervention'}], 'interventions': [{'name': 'ball-rolling (Myostorm ball)', 'type': 'DEVICE', 'description': 'the intervention group', 'armGroupLabels': ['Ball rolling']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Saman H Anvar', 'role': 'CONTACT', 'email': 'SHADJIZADEHA@MUN.CA', 'phone': '7092194733'}, {'name': 'David Behm', 'role': 'CONTACT', 'email': 'DBEHM@MUN.CA'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': "Data will be kept for at least five years, as Memorial University's policy on Integrity in Scholarly Research requires.", 'ipdSharing': 'YES', 'description': "The data will be kept confidential, and the participant codes will be used to link individual data across the experiment sessions. Data will be stored physically and digitally in Dr. Behm's office.\n\nEvery reasonable effort will be made to ensure the participants' anonymity. They will not be identified in publications without their explicit permission. All data will be collected independently and kept confidential.\n\nAll data will be stored in hardcopy and password-protected digital copy in Dr. David Behm's office at the Memorial University of Newfoundland. Consent forms will be stored separately from participant data in a locked cabinet in Dr. David Behm's office. Data access will be limited only to our research team members.\n\nData potentially may be published in an online journal article. Published data will contain no personally identifying information."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial University of Newfoundland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mitacs', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Saman Anvar', 'investigatorAffiliation': 'Memorial University of Newfoundland'}}}}