Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-27 @ 9:59 PM
Study NCT ID:
NCT06104995
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2023-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Back Beliefs Among the General Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will fill out online questionnaires. No outcome assessor will be present or in contact with the participants. The investigator that will analyse the data will not be aware of which participants are in which group.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 232}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2023-10-16', 'studyFirstSubmitQcDate': '2023-10-26', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sentiments about back vulnerability', 'timeFrame': 'One minute', 'description': 'The primary outcome is the second question of the Back-PAQ-10 ("You could injure your back if you are not careful")'}], 'secondaryOutcomes': [{'measure': 'Total Back-PAQ-10 score', 'timeFrame': 'Three minutes', 'description': 'The secondary outcome of this study is the total score of the German version of the Back-PAQ-10.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nonspecific low back pain', 'back beliefs', 'education'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'In the current study we aim to evaluate the effects of a short educational video on improving the belief that "the back is fragile and needs to be protected" among the German speaking Swiss general population. We hypothesize that a short video education program can positively change the assessed back belief among the German speaking general population of Switzerland.\n\nTo evaluate the outcomes, we will use the 10-item version of the Back Pain Attitude Questionnaire (Back-PAQ). The primary outcome is the second question of the Back-PAQ-10 ("You could injure your back if you are not careful"). The secondary outcome of this study is the total score of the Back-PAQ-10.\n\nThe design of the present study is a two-group randomized controlled trial, with one intervention and one control group in a 1:1 allocation.', 'detailedDescription': 'This study will be conducted in collaboration with HESAV (Haute Ecole de Sante Vaud). The research group at the HESAV has developed an educational website in 2020, called "www.infomaldedos.ch". The website aims to educate people on low back pain, and common unhelpful beliefs about the back - primarily targeting the belief about the fragility of the back and the need for its protection - are addressed. In the current study we are going to translate the above-mentioned website to the German language. Furthermore, we are going to assess the quality and applicability of a short video intervention among the general population, using one of the videos from the website.\n\nParticipants will be recruited through social media and emails. A link will be created to the questionnaire and the educational video with LimeSurvey. A \'randomizer\' built-in function will be used to blindly split people into intervention or control group. The link will be spread on social media platforms and through email. To induce a snowball sampling method, all participants will be asked to send the link further.\n\nThe length of the video intervention is 3 minutes. In the video, health care professionals, such as a psychologist, a medical doctor, a professor, and physiotherapist interviewed by a scientist explains the burden of LBP, how unhelpful beliefs affect treatment outcome, difficulties in the management of LBP and the optimal way of treating LBP. The scientist then inquires a representative patient about their own experiences of the management of LBP. At the end of the video the scientist encourages people to exercise despite LBP by performing various movements.\n\nThe control group will receive a neutral video about the back, selected from YouTube.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n\nExclusion Criteria:\n\n* Professionals and students with prior knowledge on the topic of interest such as physiotherapists, osteopaths, and chiropractors.'}, 'identificationModule': {'nctId': 'NCT06104995', 'briefTitle': 'Back Beliefs Among the General Population', 'organization': {'class': 'OTHER', 'fullName': 'Bern University of Applied Sciences'}, 'officialTitle': 'Effects of a Short Educational Video on Back Beliefs Among the General Population', 'orgStudyIdInfo': {'id': 'BernUASBackBeliefs'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional Educational video on back beliefs', 'description': 'Participants receive an educational video on back beliefs and its contributing factors.', 'interventionNames': ['Other: Interventional video']}, {'type': 'EXPERIMENTAL', 'label': 'Control Video Education', 'description': 'Participants receive a neutral video about the back (e.g. anatomy of the back).', 'interventionNames': ['Other: Control video']}], 'interventions': [{'name': 'Interventional video', 'type': 'OTHER', 'description': 'The educational video comprises of health care professionals explaining the durability of the back against the popular belief that the back is fragile and the multifactorial nature of back pain.', 'armGroupLabels': ['Interventional Educational video on back beliefs']}, {'name': 'Control video', 'type': 'OTHER', 'description': 'The control video is a neutral video with no content addressing back beliefs (fragility and need for protection).', 'armGroupLabels': ['Control Video Education']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bern', 'country': 'Switzerland', 'facility': 'Bern University of Applied Sciences', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Stefan Schmid, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bern UAS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bern University of Applied Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Haute Ecole de Santé Vaud', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Head of Research at the Division of Physiotherapy and Head of Spinal Movement Biomechanics Group', 'investigatorFullName': 'Stefan Schmid', 'investigatorAffiliation': 'Bern University of Applied Sciences'}}}}