Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-02-24 @ 12:13 AM
Study NCT ID:
NCT00988468
Status:
TERMINATED
Last Update Posted:
2010-11-16
First Post:
2009-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Manual Therapy Versus Exercise on Knee Osteoarthritis
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D005081', 'term': 'Exercise Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Study failed to recruit a sufficient number of subjects in the time anticipated.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-15', 'studyFirstSubmitDate': '2009-09-30', 'studyFirstSubmitQcDate': '2009-10-01', 'lastUpdatePostDateStruct': {'date': '2010-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Suprapatellar effusion measured via diagnostic ultrasound', 'timeFrame': 'Outcome measure will be measured 1 minute prior to intervention and 1 minute after intervention.'}], 'secondaryOutcomes': [{'measure': 'Pain Visual Analog Scale', 'timeFrame': 'Outcome measure will be measured 3 minutes prior to intervention and 3 minutes after intervention.'}, {'measure': 'Goniometric knee arc range of motion', 'timeFrame': 'Outcome measure will be measured 5 minutes prior to intervention and 5 minutes after intervention.'}, {'measure': 'Western Ontario and McMaster Universities Index of osteoarthritis of the knee', 'timeFrame': 'Outcome measure will be measured 12 minutes prior to intervention and 7 minutes after intervention.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Knee Osteoarthritis', 'Manual Therapy', 'Therapeutic Exercise', 'Ultrasound', 'Effusion'], 'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '18163497', 'type': 'BACKGROUND', 'citation': 'Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.'}, {'pmid': '18279766', 'type': 'BACKGROUND', 'citation': 'Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013.'}, {'pmid': '16543327', 'type': 'BACKGROUND', 'citation': 'Hunter DJ, Felson DT. Osteoarthritis. BMJ. 2006 Mar 18;332(7542):639-42. doi: 10.1136/bmj.332.7542.639. No abstract available.'}, {'pmid': '16117601', 'type': 'BACKGROUND', 'citation': 'Ottawa panel evidence-based clinical practice guidelines for therapeutic exercises and manual therapy in the management of osteoarthritis. Phys Ther. 2005 Sep;85(9):907-71.'}, {'pmid': '15478147', 'type': 'BACKGROUND', 'citation': 'Hoeksma HL, Dekker J, Ronday HK, Heering A, van der Lubbe N, Vel C, Breedveld FC, van den Ende CH. Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial. Arthritis Rheum. 2004 Oct 15;51(5):722-9. doi: 10.1002/art.20685.'}, {'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.'}, {'pmid': '11327789', 'type': 'BACKGROUND', 'citation': 'Wright A. Hypoalgesia post-manipulative therapy: a review of a potential neurophysiological mechanism. Man Ther. 1995 Nov;1(1):11-6. doi: 10.1054/math.1995.0244.'}, {'pmid': '12796883', 'type': 'BACKGROUND', 'citation': 'Sambajon VV, Cillo JE Jr, Gassner RJ, Buckley MJ. The effects of mechanical strain on synovial fibroblasts. J Oral Maxillofac Surg. 2003 Jun;61(6):707-12. doi: 10.1053/joms.2003.50141.'}, {'pmid': '16314677', 'type': 'BACKGROUND', 'citation': 'Knott EM, Tune JD, Stoll ST, Downey HF. Increased lymphatic flow in the thoracic duct during manipulative intervention. J Am Osteopath Assoc. 2005 Oct;105(10):447-56.'}, {'pmid': '8226462', 'type': 'BACKGROUND', 'citation': "Coates G, O'Brodovich H, Goeree G. Hindlimb and lung lymph flows during prolonged exercise. J Appl Physiol (1985). 1993 Aug;75(2):633-8. doi: 10.1152/jappl.1993.75.2.633."}, {'pmid': '11187981', 'type': 'BACKGROUND', 'citation': 'Havas E, Lehtonen M, Vuorela J, Parviainen T, Vihko V. Albumin clearance from human skeletal muscle during prolonged steady-state running. Exp Physiol. 2000 Nov;85(6):863-8.'}, {'pmid': '16735196', 'type': 'BACKGROUND', 'citation': 'de Miguel Mendieta E, Cobo Ibanez T, Uson Jaeger J, Bonilla Hernan G, Martin Mola E. Clinical and ultrasonographic findings related to knee pain in osteoarthritis. Osteoarthritis Cartilage. 2006 Jun;14(6):540-4. doi: 10.1016/j.joca.2005.12.012.'}, {'pmid': '15878902', 'type': 'BACKGROUND', 'citation': "Conaghan P, D'Agostino MA, Ravaud P, Baron G, Le Bars M, Grassi W, Martin-Mola E, Wakefield R, Brasseur JL, So A, Backhaus M, Malaise M, Burmester G, Schmidely N, Emery P, Dougados M. EULAR report on the use of ultrasonography in painful knee osteoarthritis. Part 2: exploring decision rules for clinical utility. Ann Rheum Dis. 2005 Dec;64(12):1710-4. doi: 10.1136/ard.2005.038026. Epub 2005 May 5."}, {'pmid': '3741515', 'type': 'BACKGROUND', 'citation': 'Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.'}, {'pmid': '7717561', 'type': 'BACKGROUND', 'citation': 'Dexter F, Chestnut DH. Analysis of statistical tests to compare visual analog scale measurements among groups. Anesthesiology. 1995 Apr;82(4):896-902. doi: 10.1097/00000542-199504000-00012.'}, {'pmid': '1381119', 'type': 'BACKGROUND', 'citation': 'Duncan GH, Bushnell MC, Talbot JD, Evans AC, Meyer E, Marrett S. Pain and activation in the thalamus. Trends Neurosci. 1992 Jul;15(7):252-3. doi: 10.1016/0166-2236(92)90062-d. No abstract available.'}, {'pmid': '2755711', 'type': 'BACKGROUND', 'citation': 'Duncan GH, Bushnell CM, Lavigne GJ. Comparison of verbal and visual analogue scales for measuring the intensity and unpleasantness of experimental pain. Pain. 1989 Jun;37(3):295-303. doi: 10.1016/0304-3959(89)90194-2.'}, {'pmid': '16445337', 'type': 'BACKGROUND', 'citation': 'Jan MH, Chai HM, Wang CL, Lin YF, Tsai LY. Effects of repetitive shortwave diathermy for reducing synovitis in patients with knee osteoarthritis: an ultrasonographic study. Phys Ther. 2006 Feb;86(2):236-44.'}, {'pmid': '16305269', 'type': 'BACKGROUND', 'citation': 'Deyle GD, Allison SC, Matekel RL, Ryder MG, Stang JM, Gohdes DD, Hutton JP, Henderson NE, Garber MB. Physical therapy treatment effectiveness for osteoarthritis of the knee: a randomized comparison of supervised clinical exercise and manual therapy procedures versus a home exercise program. Phys Ther. 2005 Dec;85(12):1301-17.'}, {'pmid': '12681951', 'type': 'BACKGROUND', 'citation': 'Miyaguchi M, Kobayashi A, Kadoya Y, Ohashi H, Yamano Y, Takaoka K. Biochemical change in joint fluid after isometric quadriceps exercise for patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2003 Apr;11(4):252-9. doi: 10.1016/s1063-4584(02)00372-2.'}]}, 'descriptionModule': {'briefSummary': "Earlier research has shown that exercising while receiving manual therapy improves function and reduces pain in people with knee osteoarthritis. However, very little is known about the mechanisms by which manual therapy and exercise reduce pain and improve function. This study will ask subjects with knee osteoarthritis to receive one of the following interventions: (1) no treatment, (2) exercise only, or (3) manual therapy only. Measures will be taken of the patient's knee range of motion, knee swelling and pain before and after receiving the intervention. These measures will be analyzed to determine what effect exercise and manual therapy applied to the knee have on improving knee range of motion and reducing knee pain and swelling. Swelling will be measured using an ultrasound device which is used to take pictures inside the knee. This type of ultrasound measurement is painless and harmless."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of knee osteoarthritis.\n\nExclusion Criteria:\n\n* Inability to ambulate at least 100 feet, ride a stationary bicycle for at least 10 minutes, or lie in the prone position for at least 10 minutes,\n* Intra-articular knee injection within one month of study inception,\n* A history of exercise induced or uncontrolled angina within three months of the study entry,\n* Severe dyspnea at rest,\n* Previous bilateral total knee arthroplasty,\n* Pregnancy, OR\n* The absence of knee pain at the time of recruitment for the study.'}, 'identificationModule': {'nctId': 'NCT00988468', 'briefTitle': 'Manual Therapy Versus Exercise on Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Texas Tech University Health Sciences Center'}, 'officialTitle': 'Effects of Manual Therapy Versus Therapeutic Exercise on Knee Osteoarthritis: A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'L10-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Manual Therapy', 'description': 'Subjects will receive oscillatory (grade 1 \\& 2) manual knee mobilization for 15 minutes at various knee range of motion positions.', 'interventionNames': ['Procedure: Manual Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Therapeutic Exercise', 'description': 'Subjects will perform 15 minutes of combined resistance exercise and aerobic exercise.', 'interventionNames': ['Behavioral: Therapeutic Exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Subjects will watch a 15 minute instructional video on a health topic.', 'interventionNames': ['Behavioral: Video Observation']}], 'interventions': [{'name': 'Manual Therapy', 'type': 'PROCEDURE', 'description': 'Grade 1 and 2 oscillatory manual mobilization of the tibiofemoral joint at various ranges of motion.', 'armGroupLabels': ['Manual Therapy']}, {'name': 'Therapeutic Exercise', 'type': 'BEHAVIORAL', 'description': 'Subjects will perform 5 minutes of lower extremity cycle ergometer with minimal resistance followed by 10 minutes of resistance exercise to the quadriceps at 3 tibiofemoral positions (0 degrees, 30 degrees and 60 degrees of knee flexion).', 'armGroupLabels': ['Therapeutic Exercise']}, {'name': 'Video Observation', 'type': 'BEHAVIORAL', 'description': 'Subjects will watch a 15 minute video on a health topic unrelated to knee osteoarthritis.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79430', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech University Health Sciences Center', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}], 'overallOfficials': [{'name': 'Dan Poulsen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas Tech University Health Sciences Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Tech University Health Sciences Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Daniel R. Poulsen, II/Assistant Professor', 'oldOrganization': 'Texas Tech University Health Sciences Center'}}}}