Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-01-05 @ 6:20 PM
Study NCT ID:
NCT06642350
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-06
First Post:
2024-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Whole-Body Electromyostimulation Versus Therapeutic Resistance Exercise for the Treatment of Non-Specific Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessors are unaware of participant status (WB-EMS or MTT) and were not allowed to ask participants correspondingly'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2024-10-11', 'studyFirstSubmitQcDate': '2024-10-11', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of non-specific low back pain from baseline to 10 week follow-up assessment as determined by the numeric rating scale 0-10', 'timeFrame': 'From enrollment (baseline assessment) to the end of treatment at 10 weeks"', 'description': 'Numeric rating scale 1-10: Zero is equivalent to no pain and 10 indicates the worst possible pain."'}], 'secondaryOutcomes': [{'measure': 'Changes of disability from baseline to 10 week follow-up assessment as determine by the Roland Morris Disability Questionnaire (RMDQ)', 'timeFrame': 'From enrollment (baseline) to the end of treatment at 10 weeks"', 'description': "RMDQ: 24-item Score that scored physical ability and activities of daily living (yes vs. no). The higher the score, the worse the patient's back-related functional status."}, {'measure': 'Changes of back extension strength from baseline to 10 week follow-up assessment as determined by the Dr. Wolf back-check device', 'timeFrame': '"From enrollment (baseline assessment) to the end of treatment at 10 weeks"', 'description': 'Dr. Wolf back-check: Isometric test device for trunk strength'}, {'measure': 'Changes of trunk flexion strength from baseline to 10 week follow-up assessment as determined by the Dr. Wolf back-check device', 'timeFrame': 'From enrollment (baseline assessment) to the end of treatment at 10 weeks"', 'description': 'Dr. Wolf Back check: Isometric test device for trunk strength'}, {'measure': 'Changes of lean body mass from baseline to 10 week assessment as determined by bio impedance assessment (BIA)', 'timeFrame': 'From enrollment (baseline assessment) to the end of treatment at 10 weeks', 'description': 'BIA: Assessment of lean body mass by direct-segmental multi-frequency bioimpedance analysis using InBody 770 (Seoul, Korea)'}, {'measure': 'Changes of body fat from baseline to 10 week follow-up assessment as determine by bio impedance analysis', 'timeFrame': 'From enrollment (baseline assessment) to the end of treatment at 10 weeks', 'description': 'BIA: Assessment of lean body mass by direct-segmental multi-frequency bio impedance analysis using InBody 770 (Seoul, Korea)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Whole-body electromyostimulation', 'non-specific chronic low-back pain', 'medical training therapy', 'outpatient clinic'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '33927646', 'type': 'BACKGROUND', 'citation': 'Micke F, Weissenfels A, Wirtz N, von Stengel S, Dormann U, Kohl M, Kleinoder H, Donath L, Kemmler W. Similar Pain Intensity Reductions and Trunk Strength Improvements Following Whole-Body Electromyostimulation vs. Whole-Body Vibration vs. Conventional Back-Strengthening Training in Chronic Non-specific Low Back Pain Patients: A Three-Armed Randomized Controlled Trial. Front Physiol. 2021 Apr 13;12:664991. doi: 10.3389/fphys.2021.664991. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'Non-specific chronic low back pain (NSCBP) is considered the leading cause of impairment of normal, symptom-free life (disability-adjusted life years - DALYs). NSCBP force more people out of work than diabetes, heart disease, hypertension, respiratory disease, asthma and cancer together. Strength and stability-oriented training programs in particular can lead to a significant improvement in NSCBP. However, back pain patients often cite time limitations and kinesiophobia (fear of movements) as the main reasons for their physical inactivity . The time-effective, joint-friendly and highly customizable whole-body electromyostimulation technology (WB-EMS) has been shown to be an effective alternative to conventional back training in two recently published clinical studies Following the successful implementation of this concept, dissemination of the positive results and testing of suitable settings for its implementation, the next step is to adapt and implement the concept as part of a knowledge transfer project in outpatient rehabilitation settings. The present project thus aimed to compare the effect of WB-EMS versus medical therapeutic therapy (MTT) using dedicated resistances devices as a recognized safe and effective treatment for low back pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women and men 40-70 years old;\n* chronic pain in the lumbar spine (at least 50 percent of the days of the last 3 months,\n* average basal pain intensity (average 7 days) in the lumbar spine on NRS 0-10: ≥2.5\n\nExclusion Criteria:\n\n* orthopedic diagnosis (i.e. specific type of LBP);\n* frequent intake of analgesics (\\>4 days/week);\n* pharmacological therapy or diseases affecting muscle metabolism (e.g., glucocorticoids);\n* no contraindications for WB-EMS application (e.g., epilepsy, cardiac pacemaker, thrombosis, and total endoprosthesis)'}, 'identificationModule': {'nctId': 'NCT06642350', 'acronym': 'BackDFGET', 'briefTitle': 'Whole-Body Electromyostimulation Versus Therapeutic Resistance Exercise for the Treatment of Non-Specific Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Whole-Body Electromyostimulation Versus Medical Therapeutic Training (MTT) Resistance Exercise for the Treatment of Non-Specific Chronic Low Back Pain in Middle-Aged to Older Cohort with Low-Back Pain.', 'orgStudyIdInfo': {'id': 'WBEMS_Back_Outpatient'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Whole-body electromyostimulation', 'description': 'WB-EMS 1.5x 20 min/week for 10 weeks', 'interventionNames': ['Other: Whole-body electrostimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Medical training therapy (MTT)', 'description': 'MTT 2x 45 min/week for 10 weeks', 'interventionNames': ['Other: Medical Training Therapy']}], 'interventions': [{'name': 'Whole-body electrostimulation', 'type': 'OTHER', 'otherNames': ['WB-EMS'], 'description': '10 weeks of WB-EMS 1.5x 20 min/week', 'armGroupLabels': ['Whole-body electromyostimulation']}, {'name': 'Medical Training Therapy', 'type': 'OTHER', 'otherNames': ['MTT'], 'description': '10 weeks of MTT 2x 45 min/week', 'armGroupLabels': ['Medical training therapy (MTT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91052', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Institute of Radiology, University Hospital Nürnberg', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'overallOfficials': [{'name': 'Wolfgang Kemmler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Radiology, University Hospital Nürnberg, Nürnberg, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rehamed Center Forchheim, Germany', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}