Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT02304120
Status:
COMPLETED
Last Update Posted:
2016-04-06
First Post:
2014-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sensorimotor Training in Low-back Pain Rehabilitation
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': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-05', 'studyFirstSubmitDate': '2014-11-17', 'studyFirstSubmitQcDate': '2014-11-25', 'lastUpdatePostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of self-reported pain on 100mm Visual Analogue Scale (VAS)', 'timeFrame': 'Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)'}, {'measure': 'Change of functional status recorded with the Oswestry Disability Index (ODI)', 'timeFrame': 'Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)'}], 'secondaryOutcomes': [{'measure': 'Centre of Pressure', 'timeFrame': 'Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)', 'description': 'Area of surface a the 95% confidence ellipse of centre of pressure displacement during postural task'}, {'measure': 'Joint Repositioning Error (segmental)', 'timeFrame': 'Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)', 'description': 'Repositioning acuity after surface perturbation.'}, {'measure': 'Uncontrolled Manifold Index (UCM)', 'timeFrame': 'Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)', 'description': 'Segmental joint configuration.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['proprioception', 'postural control', 'sensorimotor training', 'uncontrolled manifold'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '10382616', 'type': 'BACKGROUND', 'citation': 'Scholz JP, Schoner G. The uncontrolled manifold concept: identifying control variables for a functional task. Exp Brain Res. 1999 Jun;126(3):289-306. doi: 10.1007/s002210050738.'}, {'pmid': '29522571', 'type': 'DERIVED', 'citation': 'McCaskey MA, Wirth B, Schuster-Amft C, de Bruin ED. Postural sensorimotor training versus sham exercise in physiotherapy of patients with chronic non-specific low back pain: An exploratory randomised controlled trial. PLoS One. 2018 Mar 9;13(3):e0193358. doi: 10.1371/journal.pone.0193358. eCollection 2018.'}, {'pmid': '26666457', 'type': 'DERIVED', 'citation': 'McCaskey MA, Schuster-Amft C, Wirth B, de Bruin ED. Effects of postural specific sensorimotor training in patients with chronic low back pain: study protocol for randomised controlled trial. Trials. 2015 Dec 15;16:571. doi: 10.1186/s13063-015-1104-4.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effects of additional sensorimotor training (proprioceptive postural training, PPT) to conventional therapy in the treatment of chronic low-back pain. Half of the participants will receive instructed treadmill training as an active comparator against PPT. All participants receive conventional physiotherapy as prescribed by their treating medical doctors. It is expected that the PPT group will improve in postural control, proprioceptive, as well as pain and function outcomes to a significantly greater extent than the active control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with musculoskeletal low back pain (non-specific low back pain)\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Known or suspected neurological diseases or lesions\n* Traumatic injury of musculoskeletal system (fractures, tumours)\n* Spinal pathologies (e.g., tumour, infection, fracture, and inflammatory disease)\n* Previous spinal surgery\n* Presence of any contraindication to exercise (fracture or cardiovascular limitations)'}, 'identificationModule': {'nctId': 'NCT02304120', 'acronym': 'SeMoPoP', 'briefTitle': 'Sensorimotor Training in Low-back Pain Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Reha Rheinfelden'}, 'officialTitle': 'Effects of a Sensorimotor Training on Postural Control and Pain: A Parallel, Single-blinded Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '2014-0873'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sensorimotor', 'description': 'The experimental group will receive added PPT to the conventional physiotherapy. PPT will be applied by means of a neuro-orthopaedic medical device ("Posturomed®", see section 3.2). The "Posturomed" allows adaptive oscillation in the horizontal plane. Therapy instructions advise seven stages of difficulty. In all stages the patient is asked to provoke oscillation by stepping on site. After three steps, the patient must stand still on one leg for 2 seconds before he or she repeats the steps. Difficulty is increased by a) decreasing the damping through release of the breaks and b) through added juggling of a ball during the motor task (dual-task and divided attention). The next stage is reached once stabilisation in the previous stage is secured.', 'interventionNames': ['Other: Proprioceptive postural training', 'Other: Conventional physiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low-intensity activity', 'description': 'Added to conventional therapy, as administered to all participants, the control group will do added treadmill walking. The control intervention will consist of 10 minutes of walking at comfortable pace. The patient will be instructed in treadmill functions and asked to set the speed between 2 and 4 km/h. The speed should be adjusted to the level where the patient would still be able to talk comfortably.', 'interventionNames': ['Other: Treadmill training', 'Other: Conventional physiotherapy']}], 'interventions': [{'name': 'Proprioceptive postural training', 'type': 'OTHER', 'otherNames': ['Sensorimotor training'], 'armGroupLabels': ['Sensorimotor']}, {'name': 'Treadmill training', 'type': 'OTHER', 'armGroupLabels': ['Low-intensity activity']}, {'name': 'Conventional physiotherapy', 'type': 'OTHER', 'description': 'All participating patients will attend usual care according to their treatment plan (taking part in the study does not affect the treatment plan). A physiotherapy referral requests 9 treatments, each of which takes 30 minutes. These will take place twice a week for 4.5 weeks. The study protocol does not dictate the content of the physiotherapy sessions themselves, but detailed documentation of provided treatments is required (therapy documentation sheet). Additionally, the aim of the physiotherapy sessions should always include reduction of muscular imbalances and optimisation of posture.', 'armGroupLabels': ['Low-intensity activity', 'Sensorimotor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4310', 'city': 'Rheinfelden', 'state': 'Canton of Aargau', 'country': 'Switzerland', 'facility': 'Reha Rheinfelden', 'geoPoint': {'lat': 47.55437, 'lon': 7.79403}}], 'overallOfficials': [{'name': 'Michael A McCaskey, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reha Rheinfelden'}, {'name': 'Eling D. de Bruin, PD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'ETH Zurich'}, {'name': 'Corina Schuster-Amft, PT PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Reha Rheinfelden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michael A. McCaskey', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Zurich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Master of Science in Human Movement Science', 'investigatorFullName': 'Michael A. McCaskey', 'investigatorAffiliation': 'Reha Rheinfelden'}}}}