Lateral wedge insoles for medial knee osteoarthritis: 12 Month randomised controlled trial

BMJ

Volumn 342, Issue 7808, 2011, Pages

  Bennell, Kim L ^a   Bowles, Kelly Ann ^a   Payne, Craig ^b   Cicuttini, Flavia ^c   Williamson, Elizabeth ^a,c   Forbes, Andrew ^c   Hanna, Fahad ^c,d   Davies Tuck, Miranda ^c   Harris, Anthony ^e   Hinman, Rana S ^a  

^a UNIVERSITY OF MELBOURNE   (Australia)

^b LA TROBE UNIVERSITY   (Australia)

^c MONASH UNIVERSITY   (Australia)

^d BAKER IDI HEART AND DIABETES INSTITUTE   (Australia)

^e MONASH UNIVERSITY   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ARTICLE; AUSTRALIA; CONTROLLED STUDY; DISEASE COURSE; FEMALE; FLAT CONTROL INSOLE; HUMAN; KNEE OSTEOARTHRITIS; KNEE PAIN; LATERAL WEDGE INSOLE; MAJOR CLINICAL STUDY; MALE; NUCLEAR MAGNETIC RESONANCE IMAGING; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SHOE; SYMPTOMATOLOGY; AGED; ARTHRALGIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DOUBLE BLIND PROCEDURE; MIDDLE AGED; ORTHOTICS; PATIENT COMPLIANCE; PATIENT SATISFACTION; TREATMENT OUTCOME;

AGED; ARTHRALGIA; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MAGNETIC RESONANCE IMAGING; MALE; MIDDLE AGED; ORTHOTIC DEVICES; OSTEOARTHRITIS, KNEE; PATIENT COMPLIANCE; PATIENT SATISFACTION; SHOES; TREATMENT OUTCOME;

EID: 79957623389     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.d2912     Document Type: Article

References (55)

1. Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arth Rheum 2008;58:26-35.
2. Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, et al. OARSI recommendations for the management of hip and knee osteoarthritis, part II: OARSI evidence-based, expert consensus guidelines. Osteo & Cart 2008;16:137.
3. Lachance L, Sowers MF, Jamadar D, Hochberg M. The natural history of emergent osteoarthritis of the knee in women. Osteo & Cart 2002;10:849-54. (Pubitemid 35378770)
4. Miyazaki T, Wada M, Kawahara H, Sato M, Baba H, Shimada S. Dynamic load at baseline can predict radiographic disease progression in medial compartment knee osteoarthritis. Ann Rheum Dis 2002;61:617-22. (Pubitemid 34717773)
5. Hinman RS, Payne C, Metcalf BR, Wrigley TV, Bennell KL. Lateral wedges in knee osteoarthritis: what are their immediate clinical and biomechanical effects and can these predict a three-month clinical outcome? Arth Rheum 2008;59:408-15.
6. Kerrigan DC, Lelas JL, Goggins J, Merriman GJ, Kaplan RJ, Felson DT. Effectiveness of a lateral-wedge insole on knee varus torque in patients with knee osteoarthritis. Arch Phys Med Rehabil 2002;83:889-93. (Pubitemid 34747568)
7. Barrios JA, Crenshaw JR, Royer TD, Davis IS. Walking shoes and laterally wedged orthoses in the clinical management of medial tibiofemoral osteoarthritis: a one-year prospective controlled trial. Knee 2009;16:136-42.
8. Baker K, Goggins J, Xie H, Szumowski K, LaValley M, Hunter DJ, et al. A randomized crossover trial of a wedged insole for treatment of knee osteoarthritis. Arth Rheum 2007;56:1198-203. (Pubitemid 46608644)
9. Pham T, Maillefert JF, Hudry C, Kieffert P, Bourgeois P, Lechevalier D, et al. Laterally elevated wedged insoles in the treatment of medial knee osteoarthritis. A two-year prospective randomized controlled study. Osteo & Cart 2004;12:46-55.
10. Maillefert JF, Hudry C, Baron G, Kieffert P, Bourgeois P, Lechevalier D, et al. Laterally elevated wedged insoles in the treatment of medial knee osteoarthritis: a prospective randomized controlled study. Osteo & Cart 2001;9:738-45. (Pubitemid 33076765)
11. Reichmann WM, Maillefert JF, Hunter DJ, Katz JN, Conaghan PG, Losina E. Responsiveness to change and reliability of measurement of radiographic joint space width in osteoarthritis of the knee: a systematic review. Osteo & Cart 2011: published online 23 March.
12. Hunter DJ, Zhang W, Conaghan PG, Hirko K, Menashe L, Reichmann WM, et al. Responsiveness and reliability of MRI in knee osteoarthritis: a meta-analysis of published evidence. Osteo & Cart 2011: published online 9 March.
13. Hinman RS, Bowles KA, Payne C, Bennell KL. Effect of length on laterally-wedged insoles in knee osteoarthritis. Arth Rheum 2008;59:144-7. (Pubitemid 351171890)
14. Altman RD, Hochberg M, Murphy WA Jr, Wolfe F, Lequesne M. Atlas of individual radiographic features in osteoarthritis. Osteo & Cart 1995;3(suppl A):3-70.
15. Kraus VB, Vail TP, Worrell T, McDaniel G. A comparative assessment of alignment angle of the knee by radiographic and physical examination methods. Arth Rheum 2005;52:1730-5. (Pubitemid 40852881)
16. Kellgren JH, Lawrence JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis 1957;16:494-502.
17. Hunter DJ, Harvey W, Gross KD, Felson D, McCree P, Li L, et al. A randomized trial of patellofemoral bracing for treatment of patellofemoral osteoarthritis. Osteo & Cart 2011: published online 11 January.
18. Bennell K, Bowles KA, Payne C, Cicuttini F, Osborne R, Harris A, et al. Effects of laterally wedged insoles on symptoms and disease progression in medial knee osteoarthritis: a protocol for a randomised, double-blind, placebo controlled trial. BMC Musc Dis 2007;8:96.
19. Bellamy N. Osteoarthritis clinical trials: candidate variables and clinimetric properties. J Rheum 1997;24:768-78. (Pubitemid 27146099)
20. Wandel S, Juni P, Tendal B, Nuesch E, Villiger PM, Welton NJ, et al. Effects of glucosamine, chondroitin, or placebo in patients with osteoarthritis of hip or knee: network meta-analysis. BMJ 2010;341:c4675.
21. Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain 2004;8:283-91. (Pubitemid 38859657)
22. Bellamy N, Kirwan J, Boers M, Brooks P, Strand V, Tugwell P, et al. Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III. J Rheum 1997;24:799-802. (Pubitemid 27146105)
23. Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheum 1988;15:1833-40. (Pubitemid 19037656)
24. Hawthorne G, Richardson J, Osborne R. The Assessment of Quality of Life (AQoL) instrument: a psychometric measure of health-related quality of life. Qual Life Res 1999;8:209-24. (Pubitemid 29367290)
25. Washburn RA, Ficker JL. Physical Activity Scale for the Elderly (PASE): the relationship with activity measured by a portable accelerometer. J Sports Med Phys Fitness 1999;39:336-40. (Pubitemid 30096938)
26. Wluka AE, Davis SR, Bailey M, Stuckey SL, Cicuttini FM. Users of oestrogen replacement therapy have more knee cartilage than non-users. Ann Rheum Dis 2001;60:332-6. (Pubitemid 32242744)
27. Wluka AE, Stuckey S, Snaddon J, Cicuttini FM. The determinants of change in tibial cartilage volume in osteoarthritic knees. Arth Rheum 2002;46:2065-72.
28. Cicuttini FM, Wluka AE, Forbes A, Wolfe R. Comparison of tibial cartilage volume and radiologic grade of the tibiofemoral joint. Arth Rheum 2003;48:682-8.
29. Cicuttini F, Ding C, Wluka A, Davis S, Ebeling PR, Jones G. Association of cartilage defects with loss of knee cartilage in healthy,middle-age adults: a prospective study. Arth Rheum 2005;52:2033-9. (Pubitemid 40994326)
30. Ding C, Garnero P, Cicuttini F, Scott F, Cooley H, Jones G. Knee cartilage defects: association with early radiographic osteoarthritis, decreased cartilage volume, increased joint surface area and type II collagen breakdown. Osteo & Cart 2005;13:198-205. (Pubitemid 40277277)
31. Davies-Tuck ML, Wluka AE, Wang Y, Teichtahl AJ, Jones G, Ding C, et al. The natural history of cartilage defects in people with knee osteoarthritis. Osteo & Cart 2008;16:337-42. (Pubitemid 351309183)
32. Wluka AE, Hanna F, Davies-Tuck M, Wang Y, Bell RJ, Davis SR, et al. Bone marrow lesions predict increase in knee cartilage defects and loss of cartilage volume in middle-aged women without knee pain over 2 years. Ann Rheum Dis 2009;68:850-5.
33. Tanamas SK, Wluka AE, Pelletier JP, Pelletier JM, Abram F, Berry PA, et al. Bonemarrow lesions in people with knee osteoarthritis predict progression of disease and joint replacement: a longitudinal study. Rheumatology (Oxford) 2010;49:2413-9.
34. Bellamy N, Carette S, Ford PM, Kean WF, le Riche NG, Lussier A, et al. Osteoarthritis antirheumatic drug trials. III. Setting the delta for clinical trials - results of a consensus development (Delphi) exercise. J Rheum1992;19:451-7.
35. Bennell KL, Hinman RS, Metcalf BR, Buchbinder R, McConnell J, McColl G, et al. Efficacy of physiotherapy management of knee joint osteoarthritis: a randomised, double blind, placebo controlled trial. Ann Rheum Dis 2005;64:906-12. (Pubitemid 40733917)
36. Hinman RS, Crossley KM, McConnell J, Bennell KL. Efficacy of knee tape in the management of osteoarthritis of the knee: blinded randomised controlled trial. BMJ 2003;327:135.
37. Cicuttini FM, Jones G, Forbes A, Wluka AE. Rate of cartilage loss at two years predicts subsequent total knee arthroplasty: a prospective study. Ann Rheum Dis 2004;63:1124-7.
38. White IR, Thompson SG. Adjusting for partially missing baseline measurements in randomized trials. Stat Med 2005;24:993-1007. (Pubitemid 40426000)
39. Little RJA, Rubin DB. Statistical analysis with missing data. John Wiley, 1987.
40. Stuart EA, Perry DF, Le HN, Ialongo NS. Estimating intervention effects of prevention programs: accounting for noncompliance. Prev Sci 2008;9:288-98.
41. Cicuttini F, Wluka A, Hankin J, Wang Y. Longitudinal study of the relationship between knee angle and tibiofemoral cartilage volume in subjects with knee osteoarthritis. Rheumatology (Oxford) 2004;43:321-4. (Pubitemid 38313181)
42. Eckstein F, Cicuttini F, Raynauld JP, Waterton JC, Peterfy C. Magnetic resonance imaging (MRI) of articular cartilage in knee osteoarthritis (OA): morphological assessment. Osteo & Cart 2006;14(suppl A):A46-75.
43. Toda Y, Tsukimura N. Influence of concomitant heeled footwear when wearing a lateral wedged insole for medial compartment osteoarthritis of the knee. Osteo & Cart 2008;16:244-53. (Pubitemid 351218187)
44. Keating EM, Faris PM, Ritter MA, Kane J. Use of lateral heel and sole wedges in the treatment of medial osteoarthritis of the knee. Orthop Rev 1993;22:921-4. (Pubitemid 23249948)
45. Eckstein F, Nevitt M, Gimona A, Picha K, Lee JH, Davies RY, et al. Rates of change and sensitivity to change in cartilage morphology in healthy knees and in knees with mild, moderate, and end stage radiographic osteoarthritis. Arthritis Care Res (Hoboken) 2010: published online 18 October.
46. Kito N, Shinkoda K, Yamasaki T, Kanemura N, Anan M, Okanishi N, et al. Contribution of knee adduction moment impulse to pain and disability in Japanese women with medial knee osteoarthritis. Clin Biomech (Bristol, Avon) 2010;25:914-9.
47. Thorp LE, Sumner DR, Wimmer MA, Block JA. Relationship between pain and medial knee joint loading in mild radiographic knee osteoarthritis. Arth Rheum 2007;57:1254-60. (Pubitemid 47585472)
48. Maly MR, Costigan PA, Olney SJ. Mechanical factors relate to pain in knee osteoarthritis. Clin Biomech (Bristol, Avon) 2008;23:796-805.
49. Hurwitz DE, Ryals AB, Case JP, Block JA, Andriacchi TP. The knee adductionmoment during gait in subjects with knee osteoarthritis is more closely correlated with static alignment than radiographic disease severity, toe out angle and pain. J Orthop Res 2002;20:101-7. (Pubitemid 34071427)
50. Briem K, Axe MJ, Snyder-Mackler L. Medial knee joint loading increases in those who respond to hyaluronan injection for medial knee osteoarthritis. J Orthop Res 2009;27:1420-5.
51. Hurwitz DE, Ryals AR, Block JA, Sharma L, Schnitzer TJ, Andriacchi TP. Knee pain and joint loading in subjects with osteoarthritis of the knee. J Orthop Res 2000;18:572-9.
52. Somers TJ, Keefe FJ, Godiwala N, Hoyler GH. Psychosocial factors and the pain experience of osteoarthritis patients: new findings and new directions. Curr Opin Rheumatol 2009;21:501-6.
53. Toda Y, Tsukimura N, Segal N. An optimal duration of daily wear for an insole with subtalar strapping in patients with varus deformity osteoarthritis of the knee. Osteo & Cart 2005;13:353-60. (Pubitemid 40361579)
54. Toda Y, Tsukimura N. A 2-year follow-up of a study to compare the efficacy of lateral wedged insoles with subtalar strapping and inshoe lateral wedged insoles in patients with varus deformity osteoarthritis of the knee. Osteo & Cart 2006;14:231-7. (Pubitemid 43329532)
55. Toda Y, Tsukimura N. A six-month followup of a randomized trial comparing the efficacy of a lateral-wedge insole with subtalar strapping and an in-shoe lateral-wedge insole in patients with varus deformity osteoarthritis of the knee. Arth Rheum 2004;50:3129-36. (Pubitemid 39371988)