Manual Therapy Versus Exercise on Knee Osteoarthritis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Knee Osteoarthritis	Procedure: Manual Therapy Behavioral: Therapeutic Exercise Behavioral: Video Observation	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effects of Manual Therapy Versus Therapeutic Exercise on Knee Osteoarthritis: A Randomized Control Trial

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Osteoarthritis

U.S. FDA Resources

Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:

Suprapatellar effusion measured via diagnostic ultrasound [ Time Frame: Outcome measure will be measured 1 minute prior to intervention and 1 minute after intervention. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain Visual Analog Scale [ Time Frame: Outcome measure will be measured 3 minutes prior to intervention and 3 minutes after intervention. ] [ Designated as safety issue: No ]
Goniometric knee arc range of motion [ Time Frame: Outcome measure will be measured 5 minutes prior to intervention and 5 minutes after intervention. ] [ Designated as safety issue: No ]
Western Ontario and McMaster Universities Index of osteoarthritis of the knee [ Time Frame: Outcome measure will be measured 12 minutes prior to intervention and 7 minutes after intervention. ] [ Designated as safety issue: No ]

Enrollment:	1
Study Start Date:	October 2009
Study Completion Date:	August 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Manual Therapy Subjects will receive oscillatory (grade 1 & 2) manual knee mobilization for 15 minutes at various knee range of motion positions.	Procedure: Manual Therapy Grade 1 and 2 oscillatory manual mobilization of the tibiofemoral joint at various ranges of motion.
Experimental: Therapeutic Exercise Subjects will perform 15 minutes of combined resistance exercise and aerobic exercise.	Behavioral: Therapeutic Exercise 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).
Placebo Comparator: Control Subjects will watch a 15 minute instructional video on a health topic.	Behavioral: Video Observation Subjects will watch a 15 minute video on a health topic unrelated to knee osteoarthritis.

Eligibility

Ages Eligible for Study:	18 Years to 89 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Diagnosis of knee osteoarthritis.

Exclusion Criteria:

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,
Intra-articular knee injection within one month of study inception,
A history of exercise induced or uncontrolled angina within three months of the study entry,
Severe dyspnea at rest,
Previous bilateral total knee arthroplasty,
Pregnancy, OR
The absence of knee pain at the time of recruitment for the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988468

Locations

United States, Texas
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430

Sponsors and Collaborators

Texas Tech University Health Sciences Center

Investigators

Principal Investigator:

Dan Poulsen, PhD

Texas Tech University Health Sciences Center

More Information

Publications:

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[No authors listed] 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. Review.

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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.

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de Miguel Mendieta E, Cobo Ibáñez T, Usón Jaeger J, Bonilla Hernán G, Martín Mola E. Clinical and ultrasonographic findings related to knee pain in osteoarthritis. Osteoarthritis Cartilage. 2006 Jun;14(6):540-4.

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. Epub 2005 May 5.

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.

Dexter F, Chestnut DH. Analysis of statistical tests to compare visual analog scale measurements among groups. Anesthesiology. 1995 Apr;82(4):896-902.

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. No abstract available.

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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.

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.

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. Erratum in: Osteoarthritis Cartilage. 2003 Jul;11(7):548.

Responsible Party:	Daniel R. Poulsen, II/Assistant Professor, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:	NCT00988468 History of Changes
Other Study ID Numbers:	L10-004
Study First Received:	September 30, 2009
Last Updated:	November 15, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Texas Tech University Health Sciences Center:

Knee Osteoarthritis
Manual Therapy
Therapeutic Exercise
Ultrasound
Effusion

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis

Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013