Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT03858556
Status:
WITHDRAWN
Last Update Posted:
2019-03-29
First Post:
2018-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Chuna Manipulation Therapy on Gait in Patients With Lumbar Disc Herniation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008517', 'term': 'Phytotherapy'}, {'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D015671', 'term': 'Electroacupuncture'}, {'id': 'D000079742', 'term': 'Cupping Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000758', 'term': 'Anesthesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'targetDuration': '2 Weeks', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Study plan was changed, this project would not be in progress', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-27', 'studyFirstSubmitDate': '2018-12-17', 'studyFirstSubmitQcDate': '2019-02-26', 'lastUpdatePostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gait parameter change', 'timeFrame': 'baseline, 2 weeks after baseline', 'description': '\\- Time parameters(step time)'}], 'secondaryOutcomes': [{'measure': 'ODI', 'timeFrame': 'baseline, 2 weeks after baseline', 'description': 'Oswestry Disability Index(ODI)'}, {'measure': 'EQ-5D', 'timeFrame': 'baseline, 2 weeks after baseline', 'description': 'EuroQol-5 Dimension(EQ-5D)'}, {'measure': 'Lumbar ROM', 'timeFrame': 'baseline, 2 weeks after baseline', 'description': 'Lumbar Range of Motion(ROM) (Flexion/Extension/Lateral flexion/Rotation)'}, {'measure': 'SLR', 'timeFrame': 'baseline, 2 weeks after baseline', 'description': 'Straight Leg Raise test(SLR)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gait', 'effectiveness', 'treatment', 'Lumbar intervertebral disc herniation', 'Chuna'], 'conditions': ['Lumbar Disc Herniation', 'Gait Analysis', 'Manual Therapy']}, 'descriptionModule': {'briefSummary': 'Prospective Observation Study of the Effect of Chuna Manipulation Therapy on Gait in Patients With Lumbar Disc Herniation', 'detailedDescription': 'To investigate the effect of Chuna manual therapy on gate, 20 patients with lumbar disc herniation were studied. The gait analysis was performed before the first treatment, after the seventh treatment, after the 14th treatment, and compared with the data of 20 normal subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are admitted to Jaseng Hospital of Korean Medicine', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lumbar intervertebral disc herniation as confirmed by a doctor of medicine or a doctor of Korean medicine through an MRI\n* Patients with radiculopathy\n* Patients aged 19 to 60\n* Patients with an Oswestry Disability Index (ODI) of ≥10\n* Patients who have agreed to participate in the clinical study and given written informed consent\n\nExclusion Criteria:\n\n* Patients who were unable to walk for more than 5 minutes due to pain\n* Patients with a serious disease that may limit gait(such as spinal metastasis of the tumor, acute fracture and spinal dislocation)\n* Patients with chronic conditions that may interfere with the interpretation of the therapeutic effect or outcome(such as chronic kidney failure)\n* Patients with progressive neurological deficit or severe neurological symptoms such as spinal cord injury\n* Patients with severe mental illness\n* Patients who are currently on on steroids, immunosuppressants, psychiatric medications, or other medications that can affect outcome\n* Patients who are pregnant or planning a pregnancy\n* Patients who are participating in other clinical studies or if it is difficult for you to participate in clinical research as determined by the researcher'}, 'identificationModule': {'nctId': 'NCT03858556', 'briefTitle': 'Effect of Chuna Manipulation Therapy on Gait in Patients With Lumbar Disc Herniation', 'organization': {'class': 'OTHER', 'fullName': 'Jaseng Medical Foundation'}, 'officialTitle': 'Prospective Observation Study of the Effect of Chuna Manipulation Therapy on Gait in Patients With Lumbar Disc Herniation', 'orgStudyIdInfo': {'id': 'JS-CT-2018-08 Gait analysis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with lumbar disc herniation', 'description': '3times(baseline, 1weeks, 2weeks) of Observation of gait, Oswestry disability index, EQ5D-5L, Lumbar Range of motion in inpatients with lumbar intervertebral disc herniation hospitalized at Korean medicine hospital.\n\n-Integrative Korean medicine treatment Procedure/Surgery: Chuna manipulation Drug: Herbal medicine Procedure/Surgery: Bee venom pharmacopuncture Procedure/Surgery: Pharmacopuncture Procedure/Surgery: Acupuncture Procedure/Surgery: Electroacupuncture Procedure/Surgery: Cupping Other intervention(s) Other: Other intervention(s)', 'interventionNames': ['Procedure: Chuna manipulation', 'Drug: Herbal medicine', 'Procedure: Bee venom pharmacopuncture', 'Procedure: Pharmacopuncture', 'Procedure: Acupuncture', 'Procedure: Electroacupuncture', 'Procedure: Cupping', 'Other: Other intervention(s)']}, {'label': 'Normal', 'description': 'baseline Observation of gait, Oswestry disability index, EQ5D-5L, Lumbar Range of motion.\n\n-No treatment'}], 'interventions': [{'name': 'Chuna manipulation', 'type': 'PROCEDURE', 'otherNames': ['Chuna spinal manipulation'], 'description': "Chuna is a Korean spinal manipulation that incorporates spinal manipulation techniques for joint mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement. Chuna manipulation will be administered to pelvic, lumbar, thoracic, and cervical vertebrae at the physician's discretion.", 'armGroupLabels': ['Patients with lumbar disc herniation']}, {'name': 'Herbal medicine', 'type': 'DRUG', 'otherNames': ['Traditional herbal medicine'], 'description': 'Herbal medicine will be administered in water-based decoction (120ml) and dried powder (2g) form (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica).', 'armGroupLabels': ['Patients with lumbar disc herniation']}, {'name': 'Bee venom pharmacopuncture', 'type': 'PROCEDURE', 'otherNames': ['Bee venom acupuncture'], 'description': "Bee venom pharmacopuncture will be administered only after confirming a negative response to hypersensitivity skin test. Diluted bee venom (saline:bee venom ratio, 10,000:1) filtered for allergens will be injected at 4-5 acupoints proximal to the dysfunctional site at the physician's discretion. Each acupuncture point will be injected to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).", 'armGroupLabels': ['Patients with lumbar disc herniation']}, {'name': 'Pharmacopuncture', 'type': 'PROCEDURE', 'description': 'Pharmacopuncture consisting of select herbal ingredients will be administered at Hyeopcheok (Huatuo Jiaji, EX B2), Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).', 'armGroupLabels': ['Patients with lumbar disc herniation']}, {'name': 'Acupuncture', 'type': 'PROCEDURE', 'description': 'Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.', 'armGroupLabels': ['Patients with lumbar disc herniation']}, {'name': 'Electroacupuncture', 'type': 'PROCEDURE', 'description': 'Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.', 'armGroupLabels': ['Patients with lumbar disc herniation']}, {'name': 'Cupping', 'type': 'PROCEDURE', 'description': 'Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.', 'armGroupLabels': ['Patients with lumbar disc herniation']}, {'name': 'Other intervention(s)', 'type': 'OTHER', 'description': 'Patients will be allowed any other additional intervention(s) as deemed necessary by the attending physician regardless of type or dose, and patterns of use will be investigated and recorded as an pragmatic clinical study.', 'armGroupLabels': ['Patients with lumbar disc herniation']}]}, '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'}}}}