Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-27 @ 10:14 AM
Study NCT ID:
NCT04312035
Status:
COMPLETED
Last Update Posted:
2020-03-17
First Post:
2020-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Combined Interventions on Pressure Pain Threshold
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-13', 'studyFirstSubmitDate': '2020-03-04', 'studyFirstSubmitQcDate': '2020-03-13', 'lastUpdatePostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of peripheral sensitivity', 'timeFrame': 'following 3-week rehabilitation', 'description': 'peripheral sensitivity (pressure pain threshold) assessed at the local knee'}, {'measure': 'change of peripheral sensitivity', 'timeFrame': 'following 3-month', 'description': 'peripheral sensitivity (pressure pain threshold) assessed at the local knee'}], 'secondaryOutcomes': [{'measure': 'change of central sensitivity', 'timeFrame': 'following 3-week rehabilitation', 'description': 'central sensitivity (pressure pain threshold) assessed at the ipsilateral m. extensor carpi radialis longus'}, {'measure': 'change of central sensitivity', 'timeFrame': 'following 3-month', 'description': 'central sensitivity (pressure pain threshold) assessed at the ipsilateral m. extensor carpi radialis longus'}, {'measure': 'change of general pain intensity', 'timeFrame': 'following 3-week rehabilitation', 'description': 'general pain intensity from the previous week using the Visual Analogue Scale'}, {'measure': 'change of general pain intensity', 'timeFrame': 'following 3-month', 'description': 'general pain intensity from the previous week using the Visual Analogue Scale'}, {'measure': 'change of Timed Up and Go test', 'timeFrame': 'following 3-week rehabilitation', 'description': 'short test for measuring physical performance'}, {'measure': 'change of Timed Up and Go test', 'timeFrame': 'following 3-month', 'description': 'short test for measuring physical performance'}, {'measure': 'change of pain intensity during physical performance', 'timeFrame': 'following 3-week rehabilitation', 'description': 'pain intensity measured during the previously mentioned physical performance test using the 0-10 Numerating Pain Rating Scale, where 0 indicate no pain and 10 indicate worst imaginable pain'}, {'measure': 'change of pain during physical performance', 'timeFrame': 'following 3-month', 'description': 'pain intensity measured during the previously mentioned physical performance test using the 0-10 Numerating Pain Rating Scale, where 0 indicate no pain and 10 indicate worst imaginable pain'}, {'measure': 'degree of knee flexion during passive movement at the onset of knee pain', 'timeFrame': 'following 3-week rehabilitation', 'description': 'measurement of degree of knee flexion during passive movement at the onset of knee pain'}, {'measure': 'degree of knee flexion during passive movement at the onset of knee pain', 'timeFrame': 'following 3-month', 'description': 'measurement of degree of knee flexion during passive movement at the onset of knee pain'}, {'measure': 'strength of resistance of passive knee flexion at the onset of knee pain', 'timeFrame': 'following 3-week rehabilitation', 'description': 'measurement of strength of resistance arising from the anterior located tissues around the knee during passive knee flexion at the onset of pain'}, {'measure': 'strength of resistance of passive knee flexion at the onset of knee pain', 'timeFrame': 'following 3-month', 'description': 'measurement of strength of resistance arising from the anterior located tissues around the knee during passive knee flexion at the onset of pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Musculoskeletal Manipulations', 'Osteoarthritis, Knee', 'Pain Threshold', 'Conservative Treatment'], 'conditions': ['Osteo Arthritis Knee']}, 'referencesModule': {'references': [{'pmid': '24462672', 'type': 'BACKGROUND', 'citation': 'McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.'}, {'pmid': '11427321', 'type': 'BACKGROUND', 'citation': 'Bajaj P, Bajaj P, Graven-Nielsen T, Arendt-Nielsen L. Osteoarthritis and its association with muscle hyperalgesia: an experimental controlled study. Pain. 2001 Aug;93(2):107-114. doi: 10.1016/S0304-3959(01)00300-1.'}, {'pmid': '18821657', 'type': 'BACKGROUND', 'citation': 'Imamura M, Imamura ST, Kaziyama HH, Targino RA, Hsing WT, de Souza LP, Cutait MM, Fregni F, Camanho GL. Impact of nervous system hyperalgesia on pain, disability, and quality of life in patients with knee osteoarthritis: a controlled analysis. Arthritis Rheum. 2008 Oct 15;59(10):1424-31. doi: 10.1002/art.24120.'}, {'pmid': '16777467', 'type': 'BACKGROUND', 'citation': 'Moss P, Sluka K, Wright A. The initial effects of knee joint mobilization on osteoarthritic hyperalgesia. Man Ther. 2007 May;12(2):109-18. doi: 10.1016/j.math.2006.02.009. Epub 2006 Jun 13.'}]}, 'descriptionModule': {'briefSummary': 'The effect of mobilizations on decrease of peripheral and central sensitivity has been proven in KOA. Furthermore, the effect of conservative therapy has also been proven in the increase of pain threshold in KOA. However, no study has investigated the effect of these interventions combined till date in KOA.\n\nThe aim of the present study is to investigate the short-term and long-term effect of end-range mobilization in addition to conservative therapy on decrease of pressure pain threshold in KOA.', 'detailedDescription': 'The positive effect of different manual mobilizations have been proven in the management of knee osteoarthritis (KOA). Pressure pain threshold, as a measure of somatosensory function, is a well-applied measurement technique for the pain perception in KOA. The effect of mobilizations on decrease of peripheral and central sensitivity has been proven in KOA. Furthermore, few studies has revealed the effect of conservative therapy as an effective intervention in the increase of pain threshold. However, no study has investigated the effect of these interventions combined till date in KOA, which could give a long-lasting effect in the decrease of sensitization in KOA.\n\nTherefore, the aim of the present study is to investigate the short-term and long-term effect of end-range mobilization in addition to conservative therapy on decrease of pressure pain threshold in KOA.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical classification criteria of knee osteoarthritis according to the American College of Rheumatology\n* categorization as End of Range Problem based on Maitland manual therapy\n* unilateral/bilateral moderate-to-severe symptomatic tibiofemoral KOA with radiographic evidence of Kellgren-Lawrence scale 2 or 3\n* pain during weight-bearing activities at least within 6 months\n* at least 90° knee flexion\n* sufficient mental status\n\nExclusion Criteria:\n\n* acute inflammation of the knee\n* total knee replacement in the opposite side\n* class II. obesity (body mass index\\>35kg/m2)\n* severe degenerative lumbar spine disease (e.g. spondylolisthesis)\n* systemic inflammatory arthritic or neurological condition\n* physiotherapy/balneotherapy attendance or manual therapy within 3 months\n* intraarticular injections in the prior 12 months\n* use of walking aid\n* contraindication for manual therapy\n* complex regional pain syndrome\n* cognitive impairment'}, 'identificationModule': {'nctId': 'NCT04312035', 'briefTitle': 'Effect of Combined Interventions on Pressure Pain Threshold', 'organization': {'class': 'OTHER', 'fullName': 'University of Pecs'}, 'officialTitle': 'Effect of End-range Mobilization in Addition to Conservative Therapy on Decrease of Pressure Pain Threshold', 'orgStudyIdInfo': {'id': 'ML_PPT_PhysTher'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'End-range mobilization', 'description': 'End-range mobilization performed in end-position of the knee joint', 'interventionNames': ['Procedure: end-range mobilization']}, {'type': 'EXPERIMENTAL', 'label': 'Non end-range mobilization', 'description': 'Non end-range mobilization performed in loose-packed position of the knee joint', 'interventionNames': ['Procedure: Non end-range mobilization']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Sham technique performed in loose-packed position of the knee joint', 'interventionNames': ['Procedure: Control']}], 'interventions': [{'name': 'end-range mobilization', 'type': 'PROCEDURE', 'description': 'accessory technique applied on the tibiofemoral joint with the aim of increasing extensibility of the periarticular tissues', 'armGroupLabels': ['End-range mobilization']}, {'name': 'Non end-range mobilization', 'type': 'PROCEDURE', 'description': 'accessory technique applied on the tibiofemoral joint with the aim of alleviating pain', 'armGroupLabels': ['Non end-range mobilization']}, {'name': 'Control', 'type': 'PROCEDURE', 'description': 'hands-on cutaneous technique', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7815', 'city': 'Harkány', 'state': 'Please Select', 'country': 'Hungary', 'facility': 'Miklós Pozsgai', 'geoPoint': {'lat': 45.85002, 'lon': 18.23668}}], 'overallOfficials': [{'name': 'Miklós Pozsgai, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zsigmondy Vilmos Spa and Balneological Hospital of Harkány'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pecs', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}