Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT04040218
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2019-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trigger Point Dry Needling Practice in Colorado: Practitioner and Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079245', 'term': 'Dry Needling'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "The target population for this study was a representative sample of PT providers that administer and patients that receive dry needling as a treatment modality in the state of Colorado. 440 PT's licensed in Colorado and 2167 patients were recruited for this study. Purposive sampling was implemented through convenience sampling methods; by which PT respondents were included through their association to APTA CO or Kinetacore@ (an education provider in DN) and patients through their PT provider. The PT survey was sent out to APTA CO members and via a Kinetacore email list; which included approximately 900 individuals trained by Kinetacore in CO. All respondents to the PT survey were requested to provide patients with a direct link to the patient survey. Invitation was promoted by APTA CO outside of their member portal to non-members and word of mouth was encouraged."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2607}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-30', 'studyFirstSubmitDate': '2019-07-30', 'studyFirstSubmitQcDate': '2019-07-30', 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survey analysis of harm data', 'timeFrame': 'As reported during the four week survey time frame', 'description': 'Harm - "any ill-effect, no matter how small, that was unintended." Further delineation was made that minor/insignificant complaints/harms were defined as short term soreness less than 24 hours and more than 24 hours, bruising and light-headedness, and major/significant harm was defined infection or pneumothorax (PTX).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dry needling', 'physical therapy'], 'conditions': ['Dry Needling', 'Harm']}, 'descriptionModule': {'briefSummary': 'A retrospective analysis of responses following a descriptive survey to investigate the benefits and harms associated with dry needling as provided by a physical therapists in CO', 'detailedDescription': 'Two surveys were completed to identify the reported harms by physical therapists in the provision of dry needling in Colorado, and by patients who received dry needling from physical therapists in Colorado in April 2017. Retrospective analysis of the data (de-identified) was completed to provide a representative reporting on harms associated with the dry needling provided and received for patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physical therapists providing dry needling to patients in Colorado\n* Patients who had received dry needling from Physical Therapists in Colorado\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04040218', 'briefTitle': 'Trigger Point Dry Needling Practice in Colorado: Practitioner and Patient', 'organization': {'class': 'OTHER', 'fullName': 'Regis University'}, 'officialTitle': 'Harms Associated With Dry Needling Provided During Patient Care in Colorado by Physical Therapists', 'orgStudyIdInfo': {'id': '1069837-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dry Needling', 'type': 'PROCEDURE', 'description': 'Dry needling is utilized by multiple practitioners to address impairments in neuromusculoskeletal function, often related to pain and loss of mobility. Dry needling, according the American Physical Therapy Association (APTA), is defined as a skilled intervention that uses a thin filiform needle to penetrate the skin and stimulate underlying myofascial trigger points, muscular, and connective tissues for the management of neuromusculoskeletal pain and movement impairments'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80221', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Regis University', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regis University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}