Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT04956458
Status:
COMPLETED
Last Update Posted:
2022-08-10
First Post:
2021-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Lumbar MSAT on Acute Low 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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-08', 'studyFirstSubmitDate': '2021-06-25', 'studyFirstSubmitQcDate': '2021-07-07', 'lastUpdatePostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Rating Scale(NRS) of Low back pain', 'timeFrame': 'Change from baseline NRS at 4 days', 'description': "The extent of Low back pain and discomfort will be assessed using NRS. NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participant is asked to report their low back pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'."}], 'secondaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS) of Low back pain', 'timeFrame': 'Baseline(day2), day3, day4, day of discharge(up to 14days)', 'description': "VAS is an assessment index in which the patient records their pain on a 100mm line from 'no pain' at one end, and 'the most severe pain imaginable' at the other end."}, {'measure': 'Numeric Rating Scale(NRS) of leg pain', 'timeFrame': 'Baseline(day2), day3, day4, day of discharge(up to 14days), week12', 'description': "NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participant is asked to report their leg pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'."}, {'measure': 'Visual Analogue Scale (VAS) of leg pain', 'timeFrame': 'Baseline(day2), day3, day4, day of discharge(up to 14days)', 'description': "VAS is an assessment index in which the patient records their pain on a 100mm line from 'no pain' at one end, and 'the most severe pain imaginable' at the other end."}, {'measure': 'Physical examination (Lumbar range of motion)', 'timeFrame': 'Baseline(day2), day3, day4, day of discharge(up to 14days)', 'description': 'ROM of flexion, extension, lateral flexion, rotation will be measured.'}, {'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': 'Baseline(day2), day4, day of discharge(up to 14days), week12', 'description': "The Oswestry Disability Index (ODI) is a 10-item questionnaire that measures a patient's self-reported Low back pain related disability."}, {'measure': 'EuroQol 5-Dimension (EQ-5D)', 'timeFrame': 'Baseline(day2), day3, day4, day of discharge(up to 14days), week12', 'description': 'The EQ-5D is a method of indirectly calculating the weights of certain health states for quality of life after a multidimensional investigation of health states, and is the most widely used instrument for this purpose. The EQ-5D consists of 5 questions about current health state (mobility, self-care, usual activities, pain, anxiety/depression), and each question is scored on a 5-point Likert scale (1=no problems, 3=moderate problems, 5=severe problems). In this study, the investigators will use the Korean version of the EQ-5D, which has been demonstrated to be valid.'}, {'measure': 'Patient Global Impression of Change(PGIC)', 'timeFrame': 'day4, day of discharge(up to 14days), week12', 'description': 'The PGIC is an index that assesses improvements in functional limitation caused by whiplash injury. Participants rate the improvement in functional limitations after treatment on a 7-point Likert scale (1=Very much improved, 4=No change, 7=Very much worse). This index was originally developed for use in Psychology, but is currently used in various other medical fields to assess improvements in pain.'}, {'measure': 'Adverse events', 'timeFrame': 'Baseline(day2), day3, day4, day of discharge(up to 14days)', 'description': 'Check adverse events every visit'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '38513746', 'type': 'DERIVED', 'citation': 'Kwon OB, Hwang DW, Kang DH, Yoo SJ, Lee DH, Kwon M, Jang SW, Cho HW, Kim SD, Park KS, Kim ES, Lee YJ, Kim D, Ha IH. Effectiveness of lumbar motion style acupuncture treatment on inpatients with acute low back pain: A pragmatic, randomized controlled trial. Complement Ther Med. 2024 Jun;82:103035. doi: 10.1016/j.ctim.2024.103035. Epub 2024 Mar 20.'}]}, 'descriptionModule': {'briefSummary': 'This study is a single blind, randomized controlled trail. condition/disease: acute low back pain treatment/intervention: motion style acupuncture treatment', 'detailedDescription': '"Motion Style Acupuncture Treatment(MSAT)" is a therapeutic technique using acupuncture needle created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to move the part of their body actively during acupuncture treatment under physicians\' observation. This treatment is known to relieve the pain and increase the range of motion(ROM). However, there has been no specific value for the effect of this treatment.\n\nSo, the investigators will conduct a randomized controlled trials to verify the efficacy and safety of Lumbar MSAT. From March 2021 to December 2021, the investigators will collect 96 inpatients who are suffered from Low back pain with the numeric rating scale(NRS) over 5 after injury by acute traffic accident(TA). For experimental group(n=48), the investigators will conduct MSAT three times(on 2nd, 3rd and 4th day of hospitalization) and other Korean medical treatment. For control group(n=48), just Korean medical treatment except MSAT will be conducted. For these two groups, the investigators will compare NRS, Visual Analogue Scale(VAS), Range Of Motion(ROM), Oswestry Disability Index (ODI) and EuroQol 5-Dimension (EQ-5D), Patient Global Impression of Change (PGIC)."'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Criteria: Inclusion Criteria:\n\n* Patients who needs hospitalization due to acute low back pain that occurred within 7 days after traffic accident\n* Patients with NRS ≥ 5 for low back pain\n* Patients aged 19-70 years on the date they sign the consent form\n* Patients who provide consent to participate in the trial and return the informed consent form\n\nExclusion Criteria:\n\n* Patients with a specific serious disease that may cause spinal pain: malignancy, spondylitis, inflammatory spondylitis, etc.\n* Patients with progressive neurological deficits or with severe neurological symptoms- Patients who have had surgery or procedures within the last three weeks\n* The cause of pain is due to soft tissue disease, not the spine: tumors, fibromyalgia, rheumatoid arthritis, gout, etc.\n* Patients with other chronic conditions that may interfere with the interpretation of the therapeutic effects or results: cardiovascular disease, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.\n* Patients who are taking steroids, immunosuppressants, mental illness drugs, or other drugs that may affect the results of the study\n* If acupuncture is inadequate or unsafe: patients with hemorrhagic, receiving anticoagulants, severe diabetes and cardiovascular disease\n* Patients who are pregnant or planning to become pregnant\n* Patients with a serious mental illness\n* Patients who are participated in clinical trials other than observational studies without therapeutic intervention.\n* Patients who are difficult to complete the research participation agreement\n* Other patients whose participation in the trial is judged by a researcher to be problematic'}, 'identificationModule': {'nctId': 'NCT04956458', 'briefTitle': 'The Efficacy and Safety of Lumbar MSAT on Acute Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Jaseng Medical Foundation'}, 'officialTitle': 'The Efficacy and Safety of Lumbar MSAT on Inpatients With Acute Low Back Pain Caused by Traffic Accidents: A Randomized Controlled Trials', 'orgStudyIdInfo': {'id': 'JS-CT-2021-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lumbar motion style acupuncture treatment', 'description': 'The MSAT group will recieve 3 sessions of MSAT; on second, third, fourth day after hospitalization.\n\nA trained doctor of Korean medicine with at least 3 years of clinical experience will conduct the MSAT.\n\nThe MSAT group will be also treated with other Korean medical treatment everyday: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.', 'interventionNames': ['Procedure: Lumbar motion style acupuncture treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Korean medical treatment', 'description': 'The control group will be received Korean medical treatment everyday after hospitalization: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine', 'interventionNames': ['Procedure: Korean medical treatment']}], 'interventions': [{'name': 'Lumbar motion style acupuncture treatment', 'type': 'PROCEDURE', 'description': "Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to move the part of their body actively during acupuncture treatment under physicians' observation", 'armGroupLabels': ['Lumbar motion style acupuncture treatment']}, {'name': 'Korean medical treatment', 'type': 'PROCEDURE', 'description': 'acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine', 'armGroupLabels': ['Korean medical treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-896', 'city': 'Seoul', 'state': 'Gangnam-Gu', 'country': 'South Korea', 'facility': 'Jaseng Hospital of Korean Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'In-Hyuk Ha, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jaseng Medical Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jaseng Medical Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'In-Hyuk Ha, KMD', 'investigatorAffiliation': 'Jaseng Medical Foundation'}}}}