Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2025-12-30 @ 4:41 PM
Study NCT ID:
NCT04573361
Status:
COMPLETED
Last Update Posted:
2020-10-05
First Post:
2020-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Access to Chiropractic Care During the COVID-19 Healthcare Emergency in Spain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059352', 'term': 'Musculoskeletal Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Care was provided by chiropractors,'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Three arms depending on the access to chiropractic care (no access, one visit or more than one) during the 14-days period of the trial. Measures were taken at the beginning and at the end of the 14-day period.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 723}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-30', 'studyFirstSubmitDate': '2020-09-29', 'studyFirstSubmitQcDate': '2020-09-30', 'lastUpdatePostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '14 days', 'description': 'Numerical rating scale (0-10, 0 meaning no pain, 10 meaning worst pain imaginable)'}, {'measure': 'Pain frequency', 'timeFrame': '14 days', 'description': 'Likert Scale from better (1) to worst (4) outcomes, 1: occasionally, 4: constantly'}, {'measure': 'Pain evolution', 'timeFrame': '14 days', 'description': 'Likert Scale of self-perceived improvement, from better (1) to worst (5) outcomes, 1: much better, 5: much worse'}, {'measure': 'Pain interference', 'timeFrame': '14 days', 'description': 'Validated subscale form the Brief Pain Inventory, 6 categories from 0 to 10 each, the lower, the better outcomes, out of a minimal of 0 and total of 60.'}], 'secondaryOutcomes': [{'measure': 'Pain Catastrophizing Scale', 'timeFrame': '14 days', 'description': 'Validated questionnaire. Short version 4 items, Likert scale from 0 to 4, lowest score (0) better outcomes, highest score (16) worst outcomes'}, {'measure': 'Tampa Scale Kinesiophobia', 'timeFrame': '14 days', 'description': 'Validated questionnaire. Short version 11 items, Likert scale from 1 to 4, lowest score (11) better outcomes, highest score (44) worst outcomes'}, {'measure': 'General Anxiety Disorder scale', 'timeFrame': '14 days', 'description': 'Validated questionnaire 7 items, Likert scale from 0 to 3, lowest score (0) better outcomes, highest score (21) worst outcomes'}, {'measure': 'Intolerance of Uncertainty Scale', 'timeFrame': '14 days', 'description': 'Validated questionnaire. Short version 12 items, Likert scale from 1 to 5, lowest score (12) better outcomes, highest score (60) worst outcomes'}, {'measure': 'General Self-Efficacy scale', 'timeFrame': '14 days', 'description': 'Validated questionnaire 10 items, Likert scale from 1 to 10, lowest score (10) WORST outcomes, highest score (100) BETTER outcomes'}, {'measure': 'Fear of Illness and Virus Evaluation', 'timeFrame': '14 days', 'description': 'Questionnaire, subscale 10 items, Likert scale from 1 to 4, lowest score (1) WORST outcomes, highest score (40) BETTER outcomes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Musculoskeletal Pain', 'Disability Physical', 'Psychological Distress']}, 'descriptionModule': {'briefSummary': "This is a pragmatic controlled clinical trial taking place in the first phase of COVID-19 lockdown re-opening in Spain. Patients of 52 chiropractic clinics were invited to participate in a pseudo-random order (one out of every three contacted patients) as they were contacted to either schedule an appointment with their current chiropractor or not, depending on the clinic's and the patient's availability. Patients would receive chiropractic in-person care (one or more than one visits) or no care at all, for a two-week period. According to the care received, they were assigned to one of three groups (receiving no care, receiving care once, and more than once). Participants filled an online questionnaire with self-reported outcome-measures at the beginning of the two week period. A follow-up questionnaire was completed 14 days after."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chiropractic patients active when lockdown was declared, over the age of 14\n\nExclusion Criteria:\n\n* new patients in the clinic, patients with no current pain at the time of the trial'}, 'identificationModule': {'nctId': 'NCT04573361', 'briefTitle': 'Access to Chiropractic Care During the COVID-19 Healthcare Emergency in Spain', 'organization': {'class': 'OTHER', 'fullName': 'Real Centro Universitario Maria Cristina'}, 'officialTitle': 'Access to Chiropractic Care During the State of Emergency Generated by the COVID-19 Pandemic in Spain: a Pragmatic Controlled Trial', 'orgStudyIdInfo': {'id': 'ChiroCOVID19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group Control', 'description': 'Patients having no access to chiropractic treatment during the trial'}, {'type': 'EXPERIMENTAL', 'label': 'Group Chiropractic Care one session', 'description': 'Patients having access to in-person chiropractic treatment once during the trial', 'interventionNames': ['Other: Chiropractic care (one visit)']}, {'type': 'EXPERIMENTAL', 'label': 'Group Chiropractic Care multiple sessions', 'description': 'Patients having access to in-person chiropractic treatment more than once during the trial', 'interventionNames': ['Other: Chiropractic care (more than one visit)']}], 'interventions': [{'name': 'Chiropractic care (one visit)', 'type': 'OTHER', 'otherNames': ['Chiropractic Tx1'], 'description': 'One visit to the chiropractor based on the use of spinal manipulative therapy, mobilization and other forms of manual therapy, exercise therapy, patient education, advice and reassurance', 'armGroupLabels': ['Group Chiropractic Care one session']}, {'name': 'Chiropractic care (more than one visit)', 'type': 'OTHER', 'otherNames': ['Chiropractic Tx2'], 'description': 'More than one visit to the chiropractor based on the use of spinal manipulative therapy, mobilization and other forms of manual therapy, exercise therapy, patient education, advice and reassurance', 'armGroupLabels': ['Group Chiropractic Care multiple sessions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28200', 'city': 'El Escorial', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Real Centro Universitario María Cristina', 'geoPoint': {'lat': 40.59144, 'lon': -4.14738}}], 'overallOfficials': [{'name': 'Arantxa Ortega de Mues, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Madrid College of Chiropractic - Real Centro Universitario Maria Cristina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'All collected IPD will be shared, though a next phase of the study is being debated, which is why we are still undecided.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Real Centro Universitario Maria Cristina', 'class': 'OTHER'}, 'collaborators': [{'name': 'Université du Québec à Trois-Rivières', 'class': 'OTHER'}, {'name': 'University of Birmingham', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}