Manual Therapy Versus Exercise on Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Effects of Manual Therapy Versus Therapeutic Exercise on Knee Osteoarthritis: A Randomized Control Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00988468
• Other study ID #: L10-004
• Status: Terminated
• Phase: Phase 2
• First received: September 30, 2009
• Last updated: November 15, 2010
• Start date: October 2009
• Est. completion date: August 2010

Study information

• Verified date: November 2010
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Manual Therapy
Grade 1 and 2 oscillatory manual mobilization of the tibiofemoral joint at various ranges of motion.

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).
• Video Observation
Subjects will watch a 15 minute video on a health topic unrelated to knee osteoarthritis.

Locations

Country	Name	City	State
United States	Texas Tech University Health Sciences Center	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center

Country where clinical trial is conducted

United States, 

References & Publications (20)

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. — View 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. — View 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. Epub 2005 May 5. — View Citation

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. — View Citation

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

Duncan GH, Bushnell MC, 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. — View 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. — View 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. — View 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. — View Citation

Hunter DJ, Felson DT. Osteoarthritis. BMJ. 2006 Mar 18;332(7542):639-42. Review. — View 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. — View 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. — View 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. — View 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. Erratum in: Osteoarthritis Cartilage. 2003 Jul;11(7):548. — View 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. Epub 2006 Jun 13. — View 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. Review. — View 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. — View Citation

Wright A. Hypoalgesia post-manipulative therapy: a review of a potential neurophysiological mechanism. Man Ther. 1995 Nov;1(1):11-6. — View 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. Review. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suprapatellar effusion measured via diagnostic ultrasound		Outcome measure will be measured 1 minute prior to intervention and 1 minute after intervention.	No
Secondary	Pain Visual Analog Scale		Outcome measure will be measured 3 minutes prior to intervention and 3 minutes after intervention.	No
Secondary	Goniometric knee arc range of motion		Outcome measure will be measured 5 minutes prior to intervention and 5 minutes after intervention.	No
Secondary	Western Ontario and McMaster Universities Index of osteoarthritis of the knee		Outcome measure will be measured 12 minutes prior to intervention and 7 minutes after intervention.	No