期刊论文详细信息
BMC Musculoskeletal Disorders
Exercise programme with telephone follow-up for people with hand osteoarthritis – protocol for a randomised controlled trial
Ingvild Kjeken2  Eline Aas1  Petter Mowinckel3  Anne-Lene Sand-Svartrud3  Margreth Grotle4  Kåre Birger Hagen2  Nina Østerås3 
[1] Department of Health Management and Health Economics, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway;Department of Health Sciences, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway;National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo, PO Box 23 Vindern, N-0319 Oslo, Norway;FORMI (Communication Unit for Musculoskeletal Disorders), Division for Surgery and Neurology, Oslo University Hospital, Ullevål, Olso, Norway
关键词: Study protocol;    Randomised controlled trial;    Exercises;    Hand;    Osteoarthritis;   
Others  :  1128630
DOI  :  10.1186/1471-2474-15-82
 received in 2013-08-05, accepted in 2014-03-05,  发布年份 2014
PDF
【 摘 要 】

Background

Hand osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases in an adult population and may have a large influence on an individual’s functioning, health-related quality of life and participation in society. Several studies have demonstrated that exercises may reduce pain and improve functioning in people with knee OA, with a similar effect suggested for hip OA. For hand OA, available research is very limited and shows conflicting results, and high-quality randomised controlled trials are warranted.

This paper outlines the protocol for a randomised controlled trial that aims to determine the effect of an exercise intervention on self-reported hand activity performance in people with hand OA.

Methods

Participants with physician-confirmed hand OA according to the ACR clinical criteria are being recruited from two Norwegian OA cohorts: the population-based “Musculoskeletal pain in Ullensaker Study” (MUST) OA cohort, and the hospital-based Oslo Hand OA cohort. Participants are randomised into an intervention- or control group. The control group receives “usual care”, whereas the intervention group receives a 12-week exercise intervention. The intervention group attends four group sessions and is instructed to perform the exercise program three times a week at home. Adherence will be captured using self-report. During the eight weeks with no group sessions, the intervention group receives a weekly telephone call. The assessments and group sessions are being conducted locally in Ullensaker Municipality and at Diakonhjemmet Hospital, Oslo. Outcomes are collected at baseline, and at 3 and 6 months. The primary outcome measure is self-reported hand activity performance at 3 months post-randomisation, as measured by the Functional Index for Hand Osteoarthritis (FIHOA); and a patient-generated measure of disability, the Patient-Specific Functional Scale (PSFS). Secondary outcome measures are self-reported OA symptoms (e.g. pain, stiffness and fatigue), the Patient Global Assessment of disease activity, measured hand function (e.g. grip strength, thumb web space and hand dexterity) and health-related quality of life. Cost-utility and cost-effectiveness analyses will be conducted.

Discussion

This study will contribute to the knowledge on both the effect and resource use of an exercise programme with telephone follow-up on self-reported hand activity performance among people with hand OA.

Trial registration

The trial is registered at ClinicalTrials.gov with registration number: NCT01245842.

【 授权许可】

   
2014 Østerås et al.; licensee BioMed Central Ltd.

【 预 览 】
附件列表
Files Size Format View
20150225021343871.pdf 1334KB PDF download
Figure 1. 93KB Image download
【 图 表 】

Figure 1.

【 参考文献 】
  • [1]Kjeken I, Dagfinrud H, Slatkowsky-Christensen B, Mowinckel P, Uhlig T, Kvien TK, Finset A: Activity limitations and participation restrictions in women with hand osteoarthritis: patients’ descriptions and associations between dimensions of functioning. Ann Rheum Dis 2005, 64:1633-1638.
  • [2]Haugen IK, Englund M, Aliabadi P, Niu J, Clancy M, Kvien TK, Felson DT: Prevalence, incidence and progression of hand osteoarthritis in the general population: the Framingham Osteoarthritis Study. Ann Rheum Dis 2011, 70:1581-1586.
  • [3]Kwok WY, Vliet Vlieland TP, Rosendaal FR, Huizinga TW, Kloppenburg M: Limitations in daily activities are the major determinant of reduced health-related quality of life in patients with hand osteoarthritis. Ann Rheum Dis 2011, 70:334-336.
  • [4]Bijsterbosch J, Visser W, Kroon HM, Stamm T, Meulenbelt I, Huizinga TW, Kloppenburg M: Thumb base involvement in symptomatic hand osteoarthritis is associated with more pain and functional disability. Ann Rheum Dis 2010, 69:585-587.
  • [5]Haara MM, Heliovaara M, Kroger H, Arokoski JP, Manninen P, Karkkainen A, Knekt P, Impivaara O, Aromaa A: Osteoarthritis in the carpometacarpal joint of the thumb. Prevalence and associations with disability and mortality. J Bone Joint Surg Am 2004, 86-A:1452-1457.
  • [6]Zhang W, Doherty M, Leeb BF, Alekseeva L, Arden NK, Bijlsma JW, Dincer F, Dziedzic K, Hauselmann HJ, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Maheu E, Martin-Mola E, Pavelka K, Punzi L, Reiter S, Sautner J, Smolen J, Verbruggen G, Zimmermann-Gorska I: EULAR evidence based recommendations for the management of hand osteoarthritis: report of a Task Force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis 2007, 66:377-388.
  • [7]Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, Towheed T, Welch V, Wells G, Tugwell P: American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken ) 2012, 64:455-474.
  • [8]National Collaborating Centre for Chronic Conditions: Osteoarthritis: national clinical guidelines for care and management in adults. London: Royal College of Physicians; 2008.
  • [9]Fransen M, McConnell S: Exercise for osteoarthritis of the knee. Cochrane Database Syst Rev 2008, (Issue 4):Art. No. CD004376.
  • [10]Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, 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 III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage 2010, 18:476-499.
  • [11]Fransen M, McConnell S, Hernandez-Molina G, Reichenbach S: Exercise for osteoarthritis of the hip. Cochrane Database Syst Rev 2009, (Issue 3):Art. No.CD007912.
  • [12]Kjeken I, Smedslund G, Moe RH, Slatkowsky-Christensen B, Uhlig T, Hagen KB: Systematic review of design and effects of splints and exercise programs in hand osteoarthritis. Arthritis Care Res (Hoboken) 2011, 834-848.
  • [13]Boustedt C, Nordenskiold U, Lundgren NA: Effects of a hand-joint protection programme with an addition of splinting and exercise: one year follow-up. Clin Rheumatol 2009, 28:793-799.
  • [14]Wajon A, Ada L: No difference between two splint and exercise regimens for people with osteoarthritis of the thumb: a randomised controlled trial. Aust J Physiother 2005, 51:245-249.
  • [15]Stamm TA, Machold KP, Smolen JS, Fischer S, Redlich K, Graninger W, Ebner W, Erlacher L: Joint protection and home hand exercises improve hand function in patients with hand osteoarthritis: a randomized controlled trial. Arthritis Rheum 2002, 47:44-49.
  • [16]Rogers MW, Wilder FV: The effects of strength training among persons with hand osteoarthritis: a two-year follow-up study. J Hand Ther 2007, 20:244-249.
  • [17]Rogers MW, Wilder FV: Exercise and hand osteoarthritis symptomatology: a controlled crossover trial. J Hand Ther 2009, 22:10-17.
  • [18]Garfinkel MS, Schumacher HR Jr, Husain A, Levy M, Reshetar RA: Evaluation of a yoga based regimen for treatment of osteoarthritis of the hands. J Rheumatol 1994, 21:2341-2343.
  • [19]Lefler C, Armstrong J: Exercise in the treatment of osteoarthritis in the hands of the elderly. Clin Kinesiol 2004, 58:13-17.
  • [20]Moe RH, Kjeken I, Uhlig T, Hagen KB: There is inadequate evidence to determine the effectiveness of nonpharmacological and nonsurgical interventions for hand osteoarthritis: an overview of high-quality systematic reviews. Phys Ther 2009, 89:1363-1370.
  • [21]Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D: SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials. Ann Intern Med 2013, 2013(158):200-207.
  • [22]Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T: The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001, 134:663-694.
  • [23]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, 148:295-309.
  • [24]Østerås N, Risberg MA, Kvien TK, Engebretsen L, Nordsletten L, Schjervheim UB, Haugen I, Hammer HB, Provan S, Øiestad BE, Semb AG, Rollefstad S, Hagen KB, Uhlig T, Slatkowsky-Christensen B, Kjeken I, Flugsrud GB, Grotle M, Sesseng S, Edvardsen H, Natvig B: Hand, hip and knee osteoarthritis in a Norwegian population-based study - The MUST protocol. BMC Musculoskeletal Disorders 2013, 14:201. BioMed Central Full Text
  • [25]Slatkowsky-Christensen B, Kvien TK, Bellamy N: Performance of the Norwegian version of AUSCAN–a disease-specific measure of hand osteoarthritis. Osteoarthritis Cartilage 2005, 13:561-567.
  • [26]Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt K, Brown C, Cooke TD, Daniel W, Gray R: The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hand. Arthritis Rheum 1990, 33:1601-1610.
  • [27]American College of Sports Medicine Position Stand: The recommended quantity and quality of exercise for developing and maintaining cardiorespiratory and muscular fitness, and flexibility in healthy adults. Med Sci Sports Exerc 1998, 30:975-991.
  • [28]Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M: Developing and evaluating complex interventions: the new medical research council guidance. BMJ 2008, 337:a1655.
  • [29]Hendry M, Williams NH, Markland D, Wilkinson C, Maddison P: Why should we exercise when our knees hurt? A qualitative study of primary care patients with osteoarthritis of the knee. Fam Pract 2006, 23:558-567.
  • [30]Thorstensson CA, Roos EM, Petersson IF, Arvidsson B: How do middle-aged patients conceive exercise as a form of treatment for knee osteoarthritis? Disabil Rehabil 2006, 28:51-59.
  • [31]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, 16:137-162.
  • [32]Miller WR, Rollnick S: Motivational interviewing: preparing people to change addictive behavior. New York: Guilford Press; 1991.
  • [33]Miller WR, Rollnick S: Ten things that motivational interviewing is not. Behav Cogn Psychother 2009, 37:129-140.
  • [34]Maheu E, Altman RD, Bloch DA, Doherty M, Hochberg M, Mannoni A, Punzi L, Spector T, Verbruggen G, Carr A, Cicuttini F, Dreiser RL, Haraoui BP, Hart D, Pelletier JP, Ramonda R, Rovati L: Design and conduct of clinical trials in patients with osteoarthritis of the hand: recommendations from a task force of the Osteoarthritis Research Society International. Osteoarthritis Cartilage 2006, 14:303-322.
  • [35]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, 24:799-802.
  • [36]Dreiser RL, Maheu E, Guillou GB, Caspard H, Grouin JM: Validation of an algofunctional index for osteoarthritis of the hand. Rev Rhum Engl Ed 1995, 62:43S-53S.
  • [37]Stratford P, Gill C, Westaway M, Binkley J: Assessing disability and change on individual patients: a report of a patient specific measure. Physiotherapy Canada 1995, 47:258-263.
  • [38]Stamm TA, Ploner A, Machold KP, Smolen J: Moberg picking-up test in patients with inflammatory joint diseases: a survey of suitability in comparison with button test and measures of disease activity. Arthritis Rheum 2003, 49:626-632.
  • [39]Sintonen H: The 15D instrument of health-related quality of life: properties and applications. Ann Med 2001, 33:328-336.
  • [40]Goldberg D, Williams P: A user’s guide to the general health questionnaire. Berkshire: NFER-Nelson; 1988.
  • [41]Reiso H, Nygard JF, Brage S, Gulbrandsen P, Tellnes G: Work ability assessed by patients and their GPs in new episodes of sickness certification. Fam Pract 2000, 17:139-144.
  • [42]Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P: International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc 2003, 35:1381-1395.
  • [43]Fuchs R, Schwarzer R: Selbstwirksamkeit zur sportlichen Aktivität: Reliabilität und Validität eines neuen Meßinstruments. Zeitschrift für Differentielle und Diagnostische Psychologie 1994, 15:141-154.
  • [44]Moe RH, Garratt A, Slatkowsky-Christensen B, Maheu E, Mowinckel P, Kvien TK, Kjeken I, Hagen KB, Uhlig T: Concurrent evaluation of data quality, reliability and validity of the Australian/Canadian Osteoarthritis Hand Index and the Functional Index for Hand Osteoarthritis. Rheumatology (Oxford) 2010, 49:2327-2336.
  • [45]Wittoek R, Cruyssen BV, Maheu E, Verbruggen G: Cross-cultural adaptation of the Dutch version of the Functional Index for Hand Osteoarthritis (FIHOA) and a study on its construct validity. Osteoarthritis Cartilage 2009, 17:607-612.
  • [46]Dreiser RL, Maheu E, Guillou GB: Sensitivity to change of the functional index for hand osteoarthritis. Osteoarthritis Cartilage 2000, 8(Suppl A):S25-S28.
  • [47]Horn KK, Jennings S, Richardson G, Vliet DV, Hefford C, Abbott JH: The patient-specific functional scale: psychometrics, clinimetrics, and application as a clinical outcome measure. J Orthop Sports Phys Ther 2012, 42:30-42.
  • [48]Moseng T, Tveter ATH I, Dagfinrud H: Patient-Specific Function Scale: a useful tool for physiotheratpists working in primary care (In Norwegian). Fysioterapeuten 2013, 2:20-26.
  • [49]McDowell I: Measuring Health. A Guide to Rating Scales and Questionnaires., Third edition edn. Oxford: University Press; 2006.
  • [50]Abbott JH, Robertson MC, McKenzie JE, Baxter GD, Theis JC, Campbell AJ: Exercise therapy, manual therapy, or both, for osteoarthritis of the hip or knee: a factorial randomised controlled trial protocol. Trials 2009, 10:11. BioMed Central Full Text
  • [51]Hurley MV, Walsh NE, Mitchell HL, Pimm TJ, Patel A, Williamson E, Ones RH, Dieppe PA, Reeves BC: Clinical effectiveness of a rehabilitation program integrating exercise, self-management, and active coping strategies for chronic knee pain: a cluster randomized trial. Arthritis Rheum 2007, 57:1211-1219.
  • [52]Goossens ME, Rutten-van Molken MP, Vlaeyen JW, van der Linden SM: The cost diary: a method to measure direct and indirect costs in cost-effectiveness research. J Clin Epidemiol 2000, 53:688-695.
  • [53]Grotle M, Hagen KB, Uhlig T, Aas E: Cost of illness for patients with arthritis receiving multidisciplinary rehabilitation care. Rehabil Res Pract 2011, 2011:487025.
  • [54]Pham T, van der Heijde D, Altman RD, Anderson JJ, Bellamy N, Hochberg M, Simon L, Strand V, Woodworth T, Dougados M: OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis Cartilage 2004, 12:389-399.
  文献评价指标  
  下载次数:16次 浏览次数:18次