Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2026-01-13 @ 3:38 AM
Study NCT ID:
NCT05156957
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2021-11-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Physiotherapy in Patients Presenting to the Emergency Department With Nonspecific Lower Back Pain
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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-08-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-27', 'studyFirstSubmitDate': '2021-11-29', 'studyFirstSubmitQcDate': '2021-12-01', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': 'At Day 0 and at Day 7 ± 7 days', 'description': "This self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible."}], 'secondaryOutcomes': [{'measure': 'Pain Numeric Rating Scale (NRS)', 'timeFrame': 'At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days', 'description': 'The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain (\'0\' representing one pain extreme (e.g. "no pain") to \'10\' representing the other pain extreme (e.g. "pain as bad as you can imagine"))'}, {'measure': 'Feasibility of the intervention', 'timeFrame': 'At Day 0', 'description': 'The questionnaire was completed by the physiotherapist after the intervention and consisted of six questions about the feasibility of the physiotherapeutic intervention. Each question had a scale of 1 (= no, strongly disagree) to 6 (=yes, strongly agree) for possible answers.'}, {'measure': 'Patient satisfaction', 'timeFrame': 'At Day 7 ± 7 days', 'description': 'This self-completed questionnaire contains six questions about patient satisfaction with their ED visit on day 0. Each question could be answered with a score from 0 (not at all) to 10 (very much).'}, {'measure': 'Adherence to therapy recommendations', 'timeFrame': 'At Day 7 ± 7 days', 'description': 'Patients were asked if they were able to adhere to the behavioral and exercise recommendations given to them on Day 0.'}, {'measure': 'StarT Back Screening Tool (SBST)', 'timeFrame': 'Day 0, Day 7 ± 7 days, Day 42 ± 3 days', 'description': 'The SBST categorises back pain patients into 3 categories: low, medium and high risk. It consists of 9 items, each with a value of 0 or 1 points. The SBST Score is calculated by summing the points from each question, with a minimum score of 0 points and a maximum score of 9 points.'}, {'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': 'Day 21 ± 3 days, Day 42 ± 3 days', 'description': "This self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible."}, {'measure': 'Pain medication use', 'timeFrame': 'At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days', 'description': 'Questions about the use of pain medication and how long pain medication have been used.'}, {'measure': 'Utilization of medical resources', 'timeFrame': 'At Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days', 'description': 'Patients were asked if they had seen a physiotherapist, an emergency department, a general practitioner, a specialist, been hospitalized or had imaging since the last contact.'}, {'measure': 'Ability to work', 'timeFrame': 'At Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days', 'description': 'Patients were asked if they were going back to work.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physiotherapy intervention', 'Oswestry Disability Index (ODI)', 'nonspecific lower back pain'], 'conditions': ['Lower Back Pain']}, 'descriptionModule': {'briefSummary': 'Physiotherapy is a long established therapy in lower back pain. It is unknown if physiotherapeutic interventions in patients presenting to the Emergency Department (ED) with nonspecific lower back pain are beneficial. The aim of this study is to assess whether patients presenting to the emergency department with non-specific low risk low back pain would benefit from a physiotherapy intervention, as compared to patients without physiotherapy intervention at time of ED presentation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Experiencing nonspecific lower back pain\n* Presentation to the Emergency Department (ED) of the University Hospital Basel\n\nExclusion Criteria:\n\n* Inpatient disposition after ED work-up\n* "Red Flags" at time of ED-presentation:\n\n 1. Major trauma in all patients\n 2. Fractures leading to immobilization\n 3. Severe or progressive sensory alteration or weakness\n 4. Bladder or bowel dysfunction\n 5. Evidence of neurological deficit on physical examination\n 6. Severe chronic disease, such as metastasized cancer, palliative care\n* Epidural steroid injections in the last 3 months\n* Inability or contraindications to undergo the investigated intervention or to follow the study procedures, e.g. due to certain neurological disorders, language problems, psychological disorders, cognitive impairment, physical inability etc.\n* Prior enrolment in this trial'}, 'identificationModule': {'nctId': 'NCT05156957', 'acronym': 'EPAC-II', 'briefTitle': 'Effect of Physiotherapy in Patients Presenting to the Emergency Department With Nonspecific Lower Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Effect of Physiotherapy in Patients Presenting to the Emergency Department With Nonspecific Lower Back Pain. A Brief Intervention Focusing on Patient Reported Outcomes', 'orgStudyIdInfo': {'id': '2021-02166; am21Bingisser'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'The study intervention is a brief physiotherapeutic assessment, a brief information on the expected course of the condition, and a brief instruction on self-management, including three exercises for daily self-guided therapy.', 'interventionNames': ['Other: physiotherapeutic intervention']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'The control group will receive written information on the expected course of the condition, written instructions on self-management and written instructions on exercises for daily self-guided therapy.'}], 'interventions': [{'name': 'physiotherapeutic intervention', 'type': 'OTHER', 'description': 'The intervention consists of a brief physiotherapeutic assessment by a short physical performance battery, a brief information on the expected course of the condition and instructions on self-management regarding back friendly behaviour (eg. respecting the pain, staying active and back friendly movement strategies). Additionally, three exercises for daily self-guided therapy are included to the intervention: Turning in bed and coming to a sitting position, sit to stand and squats standing in front of a wall.', 'armGroupLabels': ['intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Emergency Department University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Roland Bingisser, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emergency Department University Hospital Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}