Skip to main content
Top
Published in: Trials 1/2009

Open Access 01-12-2009 | Study protocol

Exercise therapy, manual therapy, or both, for osteoarthritis of the hip or knee: a factorial randomised controlled trial protocol

Authors: J Haxby Abbott, M Clare Robertson, Joanne E McKenzie, G David Baxter, Jean-Claude Theis, A John Campbell, the MOA Trial team

Published in: Trials | Issue 1/2009

Login to get access

Abstract

Background

Non-pharmacological, non-surgical interventions are recommended as the first line of treatment for osteoarthritis (OA) of the hip and knee. There is evidence that exercise therapy is effective for reducing pain and improving function in patients with knee OA, some evidence that exercise therapy is effective for hip OA, and early indications that manual therapy may be efficacious for hip and knee OA. There is little evidence as to which approach is more effective, if benefits endure, or if providing these therapies is cost-effective for the management of this disorder. The MOA Trial (Management of OsteoArthritis) aims to test the effectiveness of two physiotherapy interventions for improving disability and pain in adults with hip or knee OA in New Zealand. Specifically, our primary objectives are to investigate whether:
1. Exercise therapy versus no exercise therapy improves disability at 12 months;
2. Manual physiotherapy versus no manual therapy improves disability at 12 months;
3. Providing physiotherapy programmes in addition to usual care is more cost-effective than usual care alone in the management of osteoarthritis at 24 months.

Methods

This is a 2 × 2 factorial randomised controlled trial. We plan to recruit 224 participants with hip or knee OA. Eligible participants will be randomly allocated to receive either: (a) a supervised multi-modal exercise therapy programme; (b) an individualised manual therapy programme; (c) both exercise therapy and manual therapy; or, (d) no trial physiotherapy. All participants will continue to receive usual medical care. The outcome assessors, orthopaedic surgeons, general medical practitioners, and statistician will be blind to group allocation until the statistical analysis is completed. The trial is funded by Health Research Council of New Zealand Project Grants (Project numbers 07/199, 07/200).

Discussion

The MOA Trial will be the first to investigate the effectiveness and cost-effectiveness of providing physiotherapy programmes of this kind, for the management of pain and disability in adults with hip or knee OA.

Trial registration

Australian New Zealand Clinical Trials Registry ref: ACTRN12608000130369.
Appendix
Available only for authorised users
Literature
1.
go back to reference National Institute for Health and Clinical Excellence: Osteoarthritis: The care and management of osteoarthritis in adults. NICE clinical guideline. 2008, 59: 1-22. National Institute for Health and Clinical Excellence: Osteoarthritis: The care and management of osteoarthritis in adults. NICE clinical guideline. 2008, 59: 1-22.
3.
go back to reference Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M: OARSI recommendations for the management of hip and knee osteoarthritis, part I: critical appraisal of existing treatment guidelines and systematic review of current research evidence. Osteoarthritis Cartilage. 2007, 15 (9): 981-1000. 10.1016/j.joca.2007.06.014.CrossRefPubMed Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M: OARSI recommendations for the management of hip and knee osteoarthritis, part I: critical appraisal of existing treatment guidelines and systematic review of current research evidence. Osteoarthritis Cartilage. 2007, 15 (9): 981-1000. 10.1016/j.joca.2007.06.014.CrossRefPubMed
4.
go back to reference Fransen M, McConnell S, Bell M: Exercise for osteoarthritis of the hip or knee. Cochrane Database of Systematic Reviews. 2003, CD004286-3 Fransen M, McConnell S, Bell M: Exercise for osteoarthritis of the hip or knee. Cochrane Database of Systematic Reviews. 2003, CD004286-3
5.
go back to reference Ottawa Panel: Ottawa panel evidence-based clinical practice guidelines for therapeutic exercises and manual therapy in the management of osteoarthritis. Phys Ther. 2005, 85 (9): 907-971. Ottawa Panel: Ottawa panel evidence-based clinical practice guidelines for therapeutic exercises and manual therapy in the management of osteoarthritis. Phys Ther. 2005, 85 (9): 907-971.
6.
go back to reference Pencharz JN, Grigoriadis E, Jansz GF, Bombardier C: A critical appraisal of clinical practice guidelines for the treatment of lower-limb osteoarthritis. Arthritis Res. 2002, 4 (1): 36-44. 10.1186/ar381.CrossRefPubMed Pencharz JN, Grigoriadis E, Jansz GF, Bombardier C: A critical appraisal of clinical practice guidelines for the treatment of lower-limb osteoarthritis. Arthritis Res. 2002, 4 (1): 36-44. 10.1186/ar381.CrossRefPubMed
7.
go back to reference Jamtvedt G, Dahm KT, Christie A, Moe RH, Haavardsholm E, Holm I, Hagen KB: Physical therapy interventions for patients with osteoarthritis of the knee: an overview of systematic reviews. Phys Ther. 2008, 88 (1): 123-136.CrossRefPubMed Jamtvedt G, Dahm KT, Christie A, Moe RH, Haavardsholm E, Holm I, Hagen KB: Physical therapy interventions for patients with osteoarthritis of the knee: an overview of systematic reviews. Phys Ther. 2008, 88 (1): 123-136.CrossRefPubMed
8.
go back to reference Vignon E, Valat JP, Rossignol M, Avouac B, Rozenberg S, Thoumie P, Avouac J, Nordin M, Hilliquin P: Osteoarthritis of the knee and hip and activity: a systematic international review and synthesis (OASIS). Joint Bone Spine. 2006, 73 (4): 442-455. 10.1016/j.jbspin.2006.03.001.CrossRefPubMed Vignon E, Valat JP, Rossignol M, Avouac B, Rozenberg S, Thoumie P, Avouac J, Nordin M, Hilliquin P: Osteoarthritis of the knee and hip and activity: a systematic international review and synthesis (OASIS). Joint Bone Spine. 2006, 73 (4): 442-455. 10.1016/j.jbspin.2006.03.001.CrossRefPubMed
9.
go back to reference Pisters MF, Veenhof C, van Meeteren NL, Ostelo RW, de Bakker DH, Schellevis FG, Dekker J: Long-Term effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a systematic review. Arthritis Rheum. 2007, 57 (7): 1245-1253. 10.1002/art.23009.CrossRefPubMed Pisters MF, Veenhof C, van Meeteren NL, Ostelo RW, de Bakker DH, Schellevis FG, Dekker J: Long-Term effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a systematic review. Arthritis Rheum. 2007, 57 (7): 1245-1253. 10.1002/art.23009.CrossRefPubMed
10.
go back to reference van Baar ME, Assendelft WJ, Dekker J, Oostendorp RA, Bijlsma JW: Effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a systematic review of randomized clinical trials. Arthritis Rheum. 1999, 42 (7): 1361-1369. 10.1002/1529-0131(199907)42:7<1361::AID-ANR9>3.0.CO;2-9.CrossRefPubMed van Baar ME, Assendelft WJ, Dekker J, Oostendorp RA, Bijlsma JW: Effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a systematic review of randomized clinical trials. Arthritis Rheum. 1999, 42 (7): 1361-1369. 10.1002/1529-0131(199907)42:7<1361::AID-ANR9>3.0.CO;2-9.CrossRefPubMed
11.
go back to reference Pelland L, Brosseau L, Wells G, MacLeay L, Lambert J, Lamothe C, Robinson V, Tugwell P: Efficacy of strengthening exercises for osteoarthritis (part I): a meta-analysis. Physical Therapy Reviews. 2004, 9: 77-108. 10.1179/108331904225005052.CrossRef Pelland L, Brosseau L, Wells G, MacLeay L, Lambert J, Lamothe C, Robinson V, Tugwell P: Efficacy of strengthening exercises for osteoarthritis (part I): a meta-analysis. Physical Therapy Reviews. 2004, 9: 77-108. 10.1179/108331904225005052.CrossRef
12.
go back to reference Roddy E, Zhang W, Doherty M, Arden NK, Barlow J, Birrell F, Carr A, Chakravarty K, Dickson J, Hay E: Evidence-based recommendations for the role of exercise in the management of osteoarthritis of the hip or knee – the MOVE consensus. Rheumatology (Oxford). 2005, 44 (1): 67-73. 10.1093/rheumatology/keh399.CrossRef Roddy E, Zhang W, Doherty M, Arden NK, Barlow J, Birrell F, Carr A, Chakravarty K, Dickson J, Hay E: Evidence-based recommendations for the role of exercise in the management of osteoarthritis of the hip or knee – the MOVE consensus. Rheumatology (Oxford). 2005, 44 (1): 67-73. 10.1093/rheumatology/keh399.CrossRef
13.
go back to reference Brosseau L, Pelland L, Wells G, MacLeay L, Lamothe C, Michaud G, Lambert J, Robinson V, Tugwell P: Efficacy of aerobic exercises for osteoarthritis (part II): a meta-analysis. Physical Therapy Reviews. 2004, 9: 125-145. 10.1179/108331904225005061.CrossRef Brosseau L, Pelland L, Wells G, MacLeay L, Lamothe C, Michaud G, Lambert J, Robinson V, Tugwell P: Efficacy of aerobic exercises for osteoarthritis (part II): a meta-analysis. Physical Therapy Reviews. 2004, 9: 125-145. 10.1179/108331904225005061.CrossRef
14.
go back to reference Tak E, Staats P, Van Hespen A, Hopman-Rock M: The effects of an exercise program for older adults with osteoarthritis of the hip. J Rheumatol. 2005, 32 (6): 1106-1113.PubMed Tak E, Staats P, Van Hespen A, Hopman-Rock M: The effects of an exercise program for older adults with osteoarthritis of the hip. J Rheumatol. 2005, 32 (6): 1106-1113.PubMed
15.
go back to reference Zhang W, Doherty M, Arden N, Bannwarth B, Bijlsma J, Gunther KP, Hauselmann HJ, Herrero-Beaumont G, Jordan K, Kaklamanis P: EULAR evidence based recommendations for the management of hip osteoarthritis: report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis. 2005, 64 (5): 669-681. 10.1136/ard.2004.028886.CrossRefPubMed Zhang W, Doherty M, Arden N, Bannwarth B, Bijlsma J, Gunther KP, Hauselmann HJ, Herrero-Beaumont G, Jordan K, Kaklamanis P: EULAR evidence based recommendations for the management of hip osteoarthritis: report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis. 2005, 64 (5): 669-681. 10.1136/ard.2004.028886.CrossRefPubMed
16.
go back to reference Hoeksma HL, Dekker J, Ronday HK, Heering A, Lubbe van der N, Vel C, Breedveld FC, Ende van den CH: Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial. Arthritis Rheum. 2004, 51 (5): 722-729. 10.1002/art.20685.CrossRefPubMed Hoeksma HL, Dekker J, Ronday HK, Heering A, Lubbe van der N, Vel C, Breedveld FC, Ende van den CH: Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial. Arthritis Rheum. 2004, 51 (5): 722-729. 10.1002/art.20685.CrossRefPubMed
17.
go back to reference 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, 85 (12): 1301-1317.PubMed 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, 85 (12): 1301-1317.PubMed
18.
go back to reference Deyle GD, Henderson NE, Matekel RL, Ryder MG, Garber MB, Allison SC: Effectiveness of manual physical therapy and exercise in osteoarthritis of the knee. A randomized, controlled trial. Ann Intern Med. 2000, 132 (3): 173-181.CrossRefPubMed Deyle GD, Henderson NE, Matekel RL, Ryder MG, Garber MB, Allison SC: Effectiveness of manual physical therapy and exercise in osteoarthritis of the knee. A randomized, controlled trial. Ann Intern Med. 2000, 132 (3): 173-181.CrossRefPubMed
19.
go back to reference MacDonald CW, Whitman JM, Cleland JA, Smith M, Hoeksma HL: Clinical outcomes following manual physical therapy and exercise for hip osteoarthritis: A case series. J Orthop Sports Phys Ther. 2006, 36 (8): 588-599.CrossRefPubMed MacDonald CW, Whitman JM, Cleland JA, Smith M, Hoeksma HL: Clinical outcomes following manual physical therapy and exercise for hip osteoarthritis: A case series. J Orthop Sports Phys Ther. 2006, 36 (8): 588-599.CrossRefPubMed
20.
go back to reference McAlister FA, Straus SE, Sackett DL, Altman DG: Analysis and reporting of factorial trials: a systematic review. JAMA. 2003, 289 (19): 2545-2553. 10.1001/jama.289.19.2545.CrossRefPubMed McAlister FA, Straus SE, Sackett DL, Altman DG: Analysis and reporting of factorial trials: a systematic review. JAMA. 2003, 289 (19): 2545-2553. 10.1001/jama.289.19.2545.CrossRefPubMed
21.
go back to reference Montgomery A, Peters T, Little P: Design, analysis and presentation of factorial randomised controlled trials. BMC Med Res Methodol. 2003, 3: 26-10.1186/1471-2288-3-26.CrossRefPubMedPubMedCentral Montgomery A, Peters T, Little P: Design, analysis and presentation of factorial randomised controlled trials. BMC Med Res Methodol. 2003, 3: 26-10.1186/1471-2288-3-26.CrossRefPubMedPubMedCentral
22.
go back to reference Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt K, Brown C, Cooke TD, Daniel W, Feldman D: The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip. Arthritis Rheum. 1991, 34 (5): 505-514. 10.1002/art.1780340502.CrossRefPubMed Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt K, Brown C, Cooke TD, Daniel W, Feldman D: The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip. Arthritis Rheum. 1991, 34 (5): 505-514. 10.1002/art.1780340502.CrossRefPubMed
23.
go back to reference Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M: 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, 29 (8): 1039-1049. 10.1002/art.1780290816.CrossRefPubMed Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M: 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, 29 (8): 1039-1049. 10.1002/art.1780290816.CrossRefPubMed
24.
go back to reference Altman RD: Criteria for classification of clinical osteoarthritis. J Rheumatol Suppl. 1991, 27: 10-12.PubMed Altman RD: Criteria for classification of clinical osteoarthritis. J Rheumatol Suppl. 1991, 27: 10-12.PubMed
25.
go back to reference Balady GJ, Chaitman B, Driscoll D, Foster C, Froelicher E, Gordon N, Pate R, Rippe J, Bazzarre T: Recommendations for cardiovascular screening, staffing, and emergency policies at health/fitness facilities. Circulation. 1998, 97 (22): 2283-2293.CrossRefPubMed Balady GJ, Chaitman B, Driscoll D, Foster C, Froelicher E, Gordon N, Pate R, Rippe J, Bazzarre T: Recommendations for cardiovascular screening, staffing, and emergency policies at health/fitness facilities. Circulation. 1998, 97 (22): 2283-2293.CrossRefPubMed
26.
go back to reference Veenhof C, Dekker J, Bijlsma JW, Ende van den CH: Influence of various recruitment strategies on the study population and outcome of a randomized controlled trial involving patients with osteoarthritis of the hip or knee. Arthritis Rheum. 2005, 53 (3): 375-382. 10.1002/art.21171.CrossRefPubMed Veenhof C, Dekker J, Bijlsma JW, Ende van den CH: Influence of various recruitment strategies on the study population and outcome of a randomized controlled trial involving patients with osteoarthritis of the hip or knee. Arthritis Rheum. 2005, 53 (3): 375-382. 10.1002/art.21171.CrossRefPubMed
27.
go back to reference Flanagan T, Coburn P, Harcourt P, Zylinski M, Jull G: Justifying the on-going physiotherapy management of long-term patients. Man Ther. 2003, 8 (4): 254-256. 10.1016/S1356-689X(03)00055-9.CrossRefPubMed Flanagan T, Coburn P, Harcourt P, Zylinski M, Jull G: Justifying the on-going physiotherapy management of long-term patients. Man Ther. 2003, 8 (4): 254-256. 10.1016/S1356-689X(03)00055-9.CrossRefPubMed
28.
go back to reference Flanagan T, Green S: The concept of maintenance physiotherapy. Aust J Physiother. 2000, 46 (4): 271-278.CrossRefPubMed Flanagan T, Green S: The concept of maintenance physiotherapy. Aust J Physiother. 2000, 46 (4): 271-278.CrossRefPubMed
29.
go back to reference van Baar ME, Dekker J, Oostendorp RA, Bijl D, Voorn TB, Bijlsma JW: Effectiveness of exercise in patients with osteoarthritis of hip or knee: nine months' follow up. Ann Rheum Dis. 2001, 60 (12): 1123-1130. 10.1136/ard.60.12.1123.CrossRefPubMedPubMedCentral van Baar ME, Dekker J, Oostendorp RA, Bijl D, Voorn TB, Bijlsma JW: Effectiveness of exercise in patients with osteoarthritis of hip or knee: nine months' follow up. Ann Rheum Dis. 2001, 60 (12): 1123-1130. 10.1136/ard.60.12.1123.CrossRefPubMedPubMedCentral
30.
go back to reference Angst F, Ewert T, Lehmann S, Aeschlimann A, Stucki G: The factor subdimensions of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) help to specify hip and knee osteoarthritis. a prospective evaluation and validation study. J Rheumatol. 2005, 32 (7): 1324-1330.PubMed Angst F, Ewert T, Lehmann S, Aeschlimann A, Stucki G: The factor subdimensions of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) help to specify hip and knee osteoarthritis. a prospective evaluation and validation study. J Rheumatol. 2005, 32 (7): 1324-1330.PubMed
31.
go back to reference Angst F, Aeschlimann A, Steiner W, Stucki G: Responsiveness of the WOMAC osteoarthritis index as compared with the SF-36 in patients with osteoarthritis of the legs undergoing a comprehensive rehabilitation intervention. Ann Rheum Dis. 2001, 60 (9): 834-840.PubMedPubMedCentral Angst F, Aeschlimann A, Steiner W, Stucki G: Responsiveness of the WOMAC osteoarthritis index as compared with the SF-36 in patients with osteoarthritis of the legs undergoing a comprehensive rehabilitation intervention. Ann Rheum Dis. 2001, 60 (9): 834-840.PubMedPubMedCentral
32.
go back to reference Angst F, Aeschlimann A, Stucki G: Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis Rheum. 2001, 45 (4): 384-391. 10.1002/1529-0131(200108)45:4<384::AID-ART352>3.0.CO;2-0.CrossRefPubMed Angst F, Aeschlimann A, Stucki G: Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis Rheum. 2001, 45 (4): 384-391. 10.1002/1529-0131(200108)45:4<384::AID-ART352>3.0.CO;2-0.CrossRefPubMed
33.
go back to reference Bellamy N, Kirwan J, Boers M, Brooks P, Strand V, Tugwell P, Altman R, Brandt K, Dougados M, Lequesne M: 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 Rheumatol. 1997, 24 (4): 799-802.PubMed Bellamy N, Kirwan J, Boers M, Brooks P, Strand V, Tugwell P, Altman R, Brandt K, Dougados M, Lequesne M: 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 Rheumatol. 1997, 24 (4): 799-802.PubMed
34.
go back to reference Pham T, Heijde Van Der D, Lassere M, Altman RD, Anderson JJ, Bellamy N, Hochberg M, Simon L, Strand V, Woodworth T: Outcome variables for osteoarthritis clinical trials: The OMERACT-OARSI set of responder criteria. J Rheumatol. 2003, 30 (7): 1648-1654.PubMed Pham T, Heijde Van Der D, Lassere M, Altman RD, Anderson JJ, Bellamy N, Hochberg M, Simon L, Strand V, Woodworth T: Outcome variables for osteoarthritis clinical trials: The OMERACT-OARSI set of responder criteria. J Rheumatol. 2003, 30 (7): 1648-1654.PubMed
35.
go back to reference Childs JD, Piva SR, Fritz JM: Responsiveness of the numeric pain rating scale in patients with low back pain. Spine. 2005, 30 (11): 1331-1334. 10.1097/01.brs.0000164099.92112.29.CrossRefPubMed Childs JD, Piva SR, Fritz JM: Responsiveness of the numeric pain rating scale in patients with low back pain. Spine. 2005, 30 (11): 1331-1334. 10.1097/01.brs.0000164099.92112.29.CrossRefPubMed
36.
go back to reference Jaeschke R, Singer J, Guyatt GH: Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989, 10 (4): 407-415. 10.1016/0197-2456(89)90005-6.CrossRefPubMed Jaeschke R, Singer J, Guyatt GH: Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989, 10 (4): 407-415. 10.1016/0197-2456(89)90005-6.CrossRefPubMed
37.
go back to reference McCarthy EK, Horvat MA, Holtsberg PA, Wisenbaker JM: Repeated chair stands as a measure of lower limb strength in sexagenarian women. J Gerontol A Biol Sci Med Sci. 2004, 59 (11): 1207-1212.CrossRefPubMed McCarthy EK, Horvat MA, Holtsberg PA, Wisenbaker JM: Repeated chair stands as a measure of lower limb strength in sexagenarian women. J Gerontol A Biol Sci Med Sci. 2004, 59 (11): 1207-1212.CrossRefPubMed
38.
go back to reference Piva SR, Fitzgerald GK, Irrgang JJ, Bouzubar F, Starz TW: Get up and go test in patients with knee osteoarthritis. Arch Phys Med Rehabil. 2004, 85 (2): 284-289. 10.1016/j.apmr.2003.05.001.CrossRefPubMed Piva SR, Fitzgerald GK, Irrgang JJ, Bouzubar F, Starz TW: Get up and go test in patients with knee osteoarthritis. Arch Phys Med Rehabil. 2004, 85 (2): 284-289. 10.1016/j.apmr.2003.05.001.CrossRefPubMed
39.
go back to reference Stratford P, Kennedy DM, Woodhouse LJ: Performance measures provide assessments of pain and function in people with advanced osteoarthritis of the hip or knee. Phys Ther. 2006, 86 (11): 1489-1496. 10.2522/ptj.20060002.CrossRefPubMed Stratford P, Kennedy DM, Woodhouse LJ: Performance measures provide assessments of pain and function in people with advanced osteoarthritis of the hip or knee. Phys Ther. 2006, 86 (11): 1489-1496. 10.2522/ptj.20060002.CrossRefPubMed
40.
go back to reference Sandborgh M, Lindberg P, Denison E: The Pain Belief Screening Instrument (PBSI): Predictive validity for disability status in persistent musculoskeletal pain. Disabil Rehabil. 2007, 1-8. Sandborgh M, Lindberg P, Denison E: The Pain Belief Screening Instrument (PBSI): Predictive validity for disability status in persistent musculoskeletal pain. Disabil Rehabil. 2007, 1-8.
41.
go back to reference Sandborgh M, Lindberg P, Denison E: Pain belief screening instrument: Development and preliminary validation of a screening instrument for disabling persistent pain. J Rehabil Med. 2007, 39 (6): 461-466. 10.2340/16501977-0072.CrossRefPubMed Sandborgh M, Lindberg P, Denison E: Pain belief screening instrument: Development and preliminary validation of a screening instrument for disabling persistent pain. J Rehabil Med. 2007, 39 (6): 461-466. 10.2340/16501977-0072.CrossRefPubMed
42.
go back to reference Whooley MA, Avins AL, Miranda J, Browner WS: Case-finding instruments for depression. Two questions are as good as many. J Gen Intern Med. 1997, 12 (7): 439-445. 10.1046/j.1525-1497.1997.00076.x.CrossRefPubMedPubMedCentral Whooley MA, Avins AL, Miranda J, Browner WS: Case-finding instruments for depression. Two questions are as good as many. J Gen Intern Med. 1997, 12 (7): 439-445. 10.1046/j.1525-1497.1997.00076.x.CrossRefPubMedPubMedCentral
43.
go back to reference Ware J, Kosinski M, Keller SD: A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996, 34 (3): 220-233. 10.1097/00005650-199603000-00003.CrossRefPubMed Ware J, Kosinski M, Keller SD: A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996, 34 (3): 220-233. 10.1097/00005650-199603000-00003.CrossRefPubMed
44.
go back to reference Altman RD, Abadie E, Avouac B, Bouvenot G, Branco J, Bruyere O, Calvo G, Devogelaer JP, Dreiser RL, Herrero-Beaumont G: Total joint replacement of hip or knee as an outcome measure for structure modifying trials in osteoarthritis. Osteoarthritis Cartilage. 2005, 13 (1): 13-19. 10.1016/j.joca.2004.10.012.CrossRefPubMed Altman RD, Abadie E, Avouac B, Bouvenot G, Branco J, Bruyere O, Calvo G, Devogelaer JP, Dreiser RL, Herrero-Beaumont G: Total joint replacement of hip or knee as an outcome measure for structure modifying trials in osteoarthritis. Osteoarthritis Cartilage. 2005, 13 (1): 13-19. 10.1016/j.joca.2004.10.012.CrossRefPubMed
45.
go back to reference Peat G, Croft P, Hay E: Clinical assessment of the osteoarthritis patient. Best Pract Res Clin Rheumatol. 2001, 15 (4): 527-544. 10.1053/berh.2001.0171.CrossRefPubMed Peat G, Croft P, Hay E: Clinical assessment of the osteoarthritis patient. Best Pract Res Clin Rheumatol. 2001, 15 (4): 527-544. 10.1053/berh.2001.0171.CrossRefPubMed
46.
go back to reference Reijman M, Hazes JM, Koes BW, Verhagen AP, Bierma-Zeinstra SM: Validity, reliability, and applicability of seven definitions of hip osteoarthritis used in epidemiological studies: a systematic appraisal. Ann Rheum Dis. 2004, 63 (3): 226-232. 10.1136/ard.2003.010348.CrossRefPubMedPubMedCentral Reijman M, Hazes JM, Koes BW, Verhagen AP, Bierma-Zeinstra SM: Validity, reliability, and applicability of seven definitions of hip osteoarthritis used in epidemiological studies: a systematic appraisal. Ann Rheum Dis. 2004, 63 (3): 226-232. 10.1136/ard.2003.010348.CrossRefPubMedPubMedCentral
47.
go back to reference New Zealand Orthopaedic Association: Introduction to the National Clinical Priority System (CPS) for Access to Publicly funded Hip or Knee Joint Replacement Surgery. 2007, Wellington, NZ: New Zealand Orthopaedic Association New Zealand Orthopaedic Association: Introduction to the National Clinical Priority System (CPS) for Access to Publicly funded Hip or Knee Joint Replacement Surgery. 2007, Wellington, NZ: New Zealand Orthopaedic Association
48.
go back to reference Angst F, Aeschlimann A, Michel BA, Stucki G: Minimal clinically important rehabilitation effects in patients with osteoarthritis of the lower extremities. J Rheumatol. 2002, 29 (1): 131-138.PubMed Angst F, Aeschlimann A, Michel BA, Stucki G: Minimal clinically important rehabilitation effects in patients with osteoarthritis of the lower extremities. J Rheumatol. 2002, 29 (1): 131-138.PubMed
49.
go back to reference Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, Heijde van der D: Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005, 64 (1): 29-33. 10.1136/ard.2004.022905.CrossRefPubMed Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, Heijde van der D: Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005, 64 (1): 29-33. 10.1136/ard.2004.022905.CrossRefPubMed
50.
go back to reference Tubach F, Wells GA, Ravaud P, Dougados M: Minimal clinically important difference, low disease activity state, and patient acceptable symptom state: methodological issues. J Rheumatol. 2005, 32 (10): 2025-2029.PubMed Tubach F, Wells GA, Ravaud P, Dougados M: Minimal clinically important difference, low disease activity state, and patient acceptable symptom state: methodological issues. J Rheumatol. 2005, 32 (10): 2025-2029.PubMed
51.
go back to reference Goodman SN, Berlin JA: The use of predicted confidence intervals when planning experiments and the misuse of power when interpreting results. Ann Intern Med. 1994, 121 (3): 200-206.CrossRefPubMed Goodman SN, Berlin JA: The use of predicted confidence intervals when planning experiments and the misuse of power when interpreting results. Ann Intern Med. 1994, 121 (3): 200-206.CrossRefPubMed
52.
go back to reference Barnard J, Meng XL: Applications of multiple imputation in medical studies: from AIDS to NHANES. Stat Methods Med Res. 1999, 8 (1): 17-36. 10.1191/096228099666230705.CrossRefPubMed Barnard J, Meng XL: Applications of multiple imputation in medical studies: from AIDS to NHANES. Stat Methods Med Res. 1999, 8 (1): 17-36. 10.1191/096228099666230705.CrossRefPubMed
53.
go back to reference Baron G, Ravaud P, Samson A, Giraudeau B: Missing data in randomized controlled trials of rheumatoid arthritis with radiographic outcomes: a simulation study. Arthritis Rheum. 2008, 59 (1): 25-31. 10.1002/art.23253.CrossRefPubMed Baron G, Ravaud P, Samson A, Giraudeau B: Missing data in randomized controlled trials of rheumatoid arthritis with radiographic outcomes: a simulation study. Arthritis Rheum. 2008, 59 (1): 25-31. 10.1002/art.23253.CrossRefPubMed
54.
go back to reference Schafer JL: Multiple imputation: a primer. Stat Methods Med Res. 1999, 8 (1): 3-15. 10.1191/096228099671525676.CrossRefPubMed Schafer JL: Multiple imputation: a primer. Stat Methods Med Res. 1999, 8 (1): 3-15. 10.1191/096228099671525676.CrossRefPubMed
55.
go back to reference Vickers AJ, Altman DG: Statistics notes: Analysing controlled trials with baseline and follow up measurements. BMJ. 2001, 323 (7321): 1123-1124. 10.1136/bmj.323.7321.1123.CrossRefPubMedPubMedCentral Vickers AJ, Altman DG: Statistics notes: Analysing controlled trials with baseline and follow up measurements. BMJ. 2001, 323 (7321): 1123-1124. 10.1136/bmj.323.7321.1123.CrossRefPubMedPubMedCentral
56.
go back to reference van Dijk GM, Dekker J, Veenhof C, Ende van den CH: Course of functional status and pain in osteoarthritis of the hip or knee: a systematic review of the literature. Arthritis Rheum. 2006, 55 (5): 779-785. 10.1002/art.22244.CrossRefPubMed van Dijk GM, Dekker J, Veenhof C, Ende van den CH: Course of functional status and pain in osteoarthritis of the hip or knee: a systematic review of the literature. Arthritis Rheum. 2006, 55 (5): 779-785. 10.1002/art.22244.CrossRefPubMed
57.
go back to reference Senn SJ: Covariate imbalance and random allocation in clinical trials. Stat Med. 1989, 8 (4): 467-475. 10.1002/sim.4780080410.CrossRefPubMed Senn SJ: Covariate imbalance and random allocation in clinical trials. Stat Med. 1989, 8 (4): 467-475. 10.1002/sim.4780080410.CrossRefPubMed
58.
go back to reference Pocock SJ, Assmann SE, Enos LE, Kasten LE: Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems. Stat Med. 2002, 21 (19): 2917-2930. 10.1002/sim.1296.CrossRefPubMed Pocock SJ, Assmann SE, Enos LE, Kasten LE: Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems. Stat Med. 2002, 21 (19): 2917-2930. 10.1002/sim.1296.CrossRefPubMed
59.
go back to reference Permutt T: Testing for imbalance of covariates in controlled experiments. Stat Med. 1990, 9 (12): 1455-1462. 10.1002/sim.4780091209.CrossRefPubMed Permutt T: Testing for imbalance of covariates in controlled experiments. Stat Med. 1990, 9 (12): 1455-1462. 10.1002/sim.4780091209.CrossRefPubMed
60.
go back to reference Altman DG: Covariate imbalance: adjustment for. Encyclopedia of biostatistics. Edited by: Armitage P, Colton T. 1998, New York: Wiley, 1000-1005. Altman DG: Covariate imbalance: adjustment for. Encyclopedia of biostatistics. Edited by: Armitage P, Colton T. 1998, New York: Wiley, 1000-1005.
61.
go back to reference Drummond MF, Sculpher MJ, Torrance GW, O'Brien BJ, Stoddart GL: Methods for the economic evaluation of health care programmes. 2005, New York, USA: Oxford University Press, Third Drummond MF, Sculpher MJ, Torrance GW, O'Brien BJ, Stoddart GL: Methods for the economic evaluation of health care programmes. 2005, New York, USA: Oxford University Press, Third
62.
go back to reference Cochrane T, Davey RC, Matthes Edwards SM: Randomised controlled trial of the cost-effectiveness of water-based therapy for lower limb osteoarthritis. Health Technol Assess. 2005, 9 (31): iii-iv. ix–xi, 1–114CrossRefPubMed Cochrane T, Davey RC, Matthes Edwards SM: Randomised controlled trial of the cost-effectiveness of water-based therapy for lower limb osteoarthritis. Health Technol Assess. 2005, 9 (31): iii-iv. ix–xi, 1–114CrossRefPubMed
63.
go back to reference Joish VN, Oderda GM: Cost-utility analysis and quality adjusted life years. J Pain Palliat Care Pharmacother. 2005, 19 (1): 57-61. 10.1300/J354v19n01_10.CrossRefPubMed Joish VN, Oderda GM: Cost-utility analysis and quality adjusted life years. J Pain Palliat Care Pharmacother. 2005, 19 (1): 57-61. 10.1300/J354v19n01_10.CrossRefPubMed
64.
go back to reference Brazier JE, Roberts J: The estimation of a preference-based measure of health from the SF-12. Med Care. 2004, 42 (9): 851-859. 10.1097/01.mlr.0000135827.18610.0d.CrossRefPubMed Brazier JE, Roberts J: The estimation of a preference-based measure of health from the SF-12. Med Care. 2004, 42 (9): 851-859. 10.1097/01.mlr.0000135827.18610.0d.CrossRefPubMed
65.
go back to reference Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P: Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008, 148 (4): 295-309.CrossRefPubMed Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P: Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008, 148 (4): 295-309.CrossRefPubMed
66.
go back to reference Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF: CONSORT for reporting randomised trials in journal and conference abstracts. Lancet. 2008, 371 (9609): 281-283. 10.1016/S0140-6736(07)61835-2.CrossRefPubMed Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF: CONSORT for reporting randomised trials in journal and conference abstracts. Lancet. 2008, 371 (9609): 281-283. 10.1016/S0140-6736(07)61835-2.CrossRefPubMed
67.
go back to reference Moher D, Schulz KF, Altman DG: The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001, 357 (9263): 1191-1194. 10.1016/S0140-6736(00)04337-3.CrossRefPubMed Moher D, Schulz KF, Altman DG: The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001, 357 (9263): 1191-1194. 10.1016/S0140-6736(00)04337-3.CrossRefPubMed
68.
go back to reference International Committee of Medical Journal Editors: Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication. 2007, Philadelphia, PA: International Committee of Medical Journal Editors International Committee of Medical Journal Editors: Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication. 2007, Philadelphia, PA: International Committee of Medical Journal Editors
Metadata
Title
Exercise therapy, manual therapy, or both, for osteoarthritis of the hip or knee: a factorial randomised controlled trial protocol
Authors
J Haxby Abbott
M Clare Robertson
Joanne E McKenzie
G David Baxter
Jean-Claude Theis
A John Campbell
the MOA Trial team
Publication date
01-12-2009
Publisher
BioMed Central
Published in
Trials / Issue 1/2009
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-10-11

Other articles of this Issue 1/2009

Trials 1/2009 Go to the issue