Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-31 @ 10:41 AM
Study NCT ID:
NCT05560100
Status:
COMPLETED
Last Update Posted:
2023-06-13
First Post:
2022-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of an Informed Consent Statement Which Communicates the Risk of Adverse Events Associated With Dry Needling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-12', 'studyFirstSubmitDate': '2022-09-21', 'studyFirstSubmitQcDate': '2022-09-28', 'lastUpdatePostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demographic Information Form', 'timeFrame': 'Up to 2 hours', 'description': 'Contains questions about the characteristics of the participants'}, {'measure': 'Ranking of Statements', 'timeFrame': 'A 2 hour virtual meeting for participants to rank statements', 'description': 'Participants will rank statements generated during the meeting to determine which statement best meets consensus within the group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['informed consent', 'adverse event', 'nominal group technique'], 'conditions': ['Dry Needling']}, 'referencesModule': {'references': [{'pmid': '14706973', 'type': 'BACKGROUND', 'citation': 'Whitney SN, McGuire AL, McCullough LB. A typology of shared decision making, informed consent, and simple consent. Ann Intern Med. 2004 Jan 6;140(1):54-9. doi: 10.7326/0003-4819-140-1-200401060-00012.'}, {'pmid': '37290346', 'type': 'DERIVED', 'citation': 'Ickert EC, Griswold D, Learman K, Cook C. Creation of a risk of harms informed consent form for dry needling: A nominal group technique. Musculoskelet Sci Pract. 2023 Aug;66:102778. doi: 10.1016/j.msksp.2023.102778. Epub 2023 May 24.'}]}, 'descriptionModule': {'briefSummary': "As Dry Needling (DN) continues to see increased use in the clinic, there is a need to establish adverse events that could occur as a result of DN intervention. The adverse events are important to consider when an individual needs to make an informed decision regarding their care. It is important to consider how such information should be presented during the informed consent process to improve an individual's ability to make a sound decision regarding their own personal care.", 'detailedDescription': 'Dry Needling (DN) has been defined by a Task Force organized by the Federation of State Boards of Physical Therapy (FSBPT) as "a skilled intervention performed by a physical therapist using filiform needles to penetrate the skin and/or underlying tissues to affect change in body structures and functions for the evaluation and management of neuromusculoskeletal conditions, pain, movement impairments, and disability". As DN interest continues to expand and studies continue to show the feasibility of applying DN to a wider range of pathological conditions, there is a need to understand the risks related to the use of DN. Understanding the risks associated with DN will allow for improvements in clinical decision making regarding it\'s application in the clinic.\n\nEnhancing patient choice is a central theme of medical ethics and law. Informed consent (IC) is the legal process used to promote patient autonomy while concepts of shared decision making (SDM) is a widely promoted ethical approach. IC is a means of respecting the autonomous preferences of persons seeking health care or participation in research. Empowerment of the patient is important in healthcare and can lead to improvements in overall quality of patient care and outcomes.\n\nTo date, there has been little research conducted that explored the topic of how risks should be presented during the IC process. The purpose of this study will be to utilize expert consensus to establish a risk statement for adverse events associated with DN that an be used during IC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Dry Needling Experts, Legal Experts, Policy Experts, and Patients (Defined with inclusion criteria above).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants must be 18 years old or above and be able to read/write in English Participants must provide informed consent Participants must meet the criteria of one of the previously defined cohort groups used in the study\n\nDry Needling Experts\n\n(1) Must have \\>= 5 years of clinical practice performing dry needling and at least ONE of the following secondary criteria:\n\n1. Certification in Dry Needling\n2. Completion of a manual therapy fellowship that included dry needling training\n3. \\>= 1 total scholarly product (poster presentation, author of a peer-reviewed publication) involving the use of dry needling\n\nLegal Expert\n\nAn individual who is an attorney and who has had training in health law as evidenced by at least ONE of the following criteria:\n\n1. Training in health law as evidenced by ONE of the following:\n\n 1. Concentration/Certification in Health Law\n 2. L.L.M in health or medical law\n 3. SJD in health law\n2. Experience in litigating medical malpractice cases involving failure to obtain informed consent\n3. Published scholarship on informed consent in an academic journal (\\>= 1) Policy Expert\n\nAn individual who has a degree in bioethics with at least ONE of the following criteria:\n\n1. \\>= 5 years of experience in obtaining informed consent or an advanced graduate degree in bioethics\n2. Has served on ethics related committee in a healthcare institution or healthcare society/professional association\n3. Is or has been a member of a state licensing board\n\nPatient Must have participated in \\>= 1 session of dry needling treatment and not be a healthcare provider\n\nExclusion Criteria:\n\nParticipants who did not provide informed consent Participants who did not meet the inclusion criteria of one of the four cohort groups defined in the study.'}, 'identificationModule': {'nctId': 'NCT05560100', 'acronym': 'DNICNGT', 'briefTitle': 'Development of an Informed Consent Statement Which Communicates the Risk of Adverse Events Associated With Dry Needling', 'organization': {'class': 'OTHER', 'fullName': 'Youngstown State University'}, 'officialTitle': 'Development of an Informed Consent Statement Which Communicates the Risk of Adverse Events Associated With Dry Needling Using an Online Nominal Group', 'orgStudyIdInfo': {'id': '2022-173'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Must have participated in \\>= 1 session of dry needling treatment and not be a healthcare provider.', 'interventionNames': ['Other: Nominal Group Technique - 2 to 3 hour virtual meeting']}, {'label': 'Dry Needling Experts', 'description': '(1) Must have \\>= 5 years of clinical practice performing dry needling and at least ONE of the following secondary criteria:\n\n1. Certification in Dry Needling\n2. Completion of a manual therapy fellowship that included dry needling training\n3. \\>= 1 total scholarly product (poster presentation, author of a peer-reviewed publication) involving the use of dry needling', 'interventionNames': ['Other: Nominal Group Technique - 2 to 3 hour virtual meeting']}, {'label': 'Policy Experts', 'description': 'An individual who has a degree in bioethics with at least ONE of the following criteria:\n\n1. \\>= 5 years of experience in obtaining informed consent or an advanced graduate degree in bioethics\n2. Has served on ethics related committee in a healthcare institution or healthcare society/professional association\n3. Is or has been a member of a state licensing board', 'interventionNames': ['Other: Nominal Group Technique - 2 to 3 hour virtual meeting']}, {'label': 'Legal Experts', 'description': 'An individual who is an attorney and who has had training in health law as evidenced by at least ONE of the following criteria:\n\n1. Evidence of training based on ONE of the follow:\n\n 1. Concentration/Certification in Health Law\n 2. L.L.M in health or medical law\n 3. SJD in health law\n2. Experience in litigating medical malpractice cases involving failure to obtain informed consent\n3. Published scholarship on informed consent in an academic journal (\\>= 1)', 'interventionNames': ['Other: Nominal Group Technique - 2 to 3 hour virtual meeting']}], 'interventions': [{'name': 'Nominal Group Technique - 2 to 3 hour virtual meeting', 'type': 'OTHER', 'description': 'Participants will be invited to a 2-3 online virtual online meeting with the goal of constructing and defining elements for producing a risk statement for dry needling that can be used for informed consent.', 'armGroupLabels': ['Dry Needling Experts', 'Legal Experts', 'Patients', 'Policy Experts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44555', 'city': 'Youngstown', 'state': 'Ohio', 'country': 'United States', 'facility': 'Youngstown State University', 'geoPoint': {'lat': 41.09978, 'lon': -80.64952}}], 'overallOfficials': [{'name': 'Edmund C Ickert, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Youngstown State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Youngstown State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}