Clinical trial NCT00988468: Manual Therapy Versus Exercise on Knee Osteoarthritis
Official title: Effects of Manual Therapy Versus Therapeutic Exercise on Knee Osteoarthritis: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Knee Osteoarthritis
Keywords: Knee Osteoarthritis
Manual Therapy
Therapeutic Exercise
Ultrasound
Effusion
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2009-10-02
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Suprapatellar effusion measured via diagnostic ultrasound
timeFrame: Outcome measure will be measured 1 minute prior to intervention and 1 minute after intervention.
Secondary outcomes:
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.
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: Dan Poulsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Hunter DJ, Felson DT. Osteoarthritis. BMJ. 2006 Mar 18;332(7542):639-42. doi: 10.1136/bmj.332.7542.639. No abstract available.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.