Feasibility and potential effectiveness of a non-pharmacological multidisciplinary care programme for persons with generalised osteoarthritis: a randomised, multiple-baseline single-case study

Objectives To evaluate the feasibility and potential effectiveness of a 12-week, non-pharmacological multidisciplinary intervention in patients with generalised osteoarthritis (GOA). Design A randomised, concurrent, multiple-baseline single-case design. During the baseline period, the intervention period and the postintervention period, all participants completed several health outcomes twice a week on Visual Analogue Scales. Setting Rheumatology outpatient department of a specialised hospital in the Netherlands. Participants 1 man and four women (aged 51–76 years) diagnosed with GOA. Primary outcome measures To assess feasibility, the authors assessed the number of dropouts and adverse events, adherence rates and patients' satisfaction. Secondary outcome measures To assess the potential effectiveness, the authors assessed pain and self-efficacy using visual data inspection and randomisation tests. Results The intervention was feasible in terms of adverse events (none) and adherence rate but not in terms of participants' satisfaction with the intervention. Visual inspection of the data and randomisation testing demonstrated no effects on pain (p=0.93) or self-efficacy (p=0.85). Conclusions The results of the present study indicate that the proposed intervention for patients with GOA was insufficiently feasible and effective. The data obtained through this multiple-baseline study have highlighted several areas in which the therapy programme can be optimised.

[1]  T. Huizinga,et al.  Illness perceptions in patients with osteoarthritis: change over time and association with disability. , 2009, Arthritis and rheumatism.

[2]  K. Ottenbacher,et al.  The statistical analysis of single-subject data: a comparative examination. , 1994, Physical therapy.

[3]  Celeratlon Line b,et al.  The Statistical Analysis of Single-Subject Data : A Comparative Examination , 2006 .

[4]  Theodore J. Christ.  Experimental control and threats to internal validity of concurrent and nonconcurrent multiple baseline designs , 2007 .

[5]  E. Taal,et al.  Arthritis patients show long-term benefits from 3 weeks intensive exercise training directly following hospital discharge. , 2007, Rheumatology.

[6]  I. Kant,et al.  Fatigue among working people: validity of a questionnaire measure , 2000, Occupational and environmental medicine.

[7]  C. Bombardier,et al.  Measuring the whole or the parts? Validity, reliability, and responsiveness of the Disabilities of the Arm, Shoulder and Hand outcome measure in different regions of the upper extremity. , 2001, Journal of hand therapy : official journal of the American Society of Hand Therapists.

[8]  J. Jacobs,et al.  Beyond unfavorable thinking: the illness cognition questionnaire for chronic diseases. , 2001, Journal of consulting and clinical psychology.

[9]  Patrick Onghena,et al.  Randomization tests for multiple-baseline designs: An extension of the SCRT-R package , 2009, Behavior research methods.

[10]  S. Harris,et al.  Single-subject research in rehabilitation: a review of studies using AB, withdrawal, multiple baseline, and alternating treatments designs. , 1997, Archives of physical medicine and rehabilitation.

[11]  T. Stürmer,et al.  Prevalence of generalised osteoarthritis in patients with advanced hip and knee osteoarthritis: The Ulm Osteoarthritis Study , 1998, Annals of the rheumatic diseases.

[12]  L. Houtkooper,et al.  Exercise motivation, eating, and body image variables as predictors of weight control. , 2006, Medicine and science in sports and exercise.

[13]  R. D. de Bie,et al.  The Dutch Lower Extremity Functional Scale was highly reliable, valid and responsive in individuals with hip/knee osteoarthritis: a validation study , 2012, BMC Musculoskeletal Disorders.

[14]  J E Janosky,et al.  Use of the single subject design for practice based primary care research , 2005, Postgraduate Medical Journal.

[15]  Dean Schillinger,et al.  Goal setting in diabetes self-management: taking the baby steps to success. , 2009, Patient education and counseling.

[16]  H. D. de Vet,et al.  A patient-specific approach for measuring functional status in low back pain. , 1999, Journal of manipulative and physiological therapeutics.

[17]  J. E. Carr.  Recommendations for reporting multiple‐baseline designs across participants , 2005 .

[18]  J. Bott.  Single Subject Experimental Design , 1994 .

[19]  I. Stiell,et al.  Clinically important change in the visual analog scale after adequate pain control. , 2003, Academic emergency medicine : official journal of the Society for Academic Emergency Medicine.

[20]  John Ferron,et al.  Statistical Power of Randomization Tests Used with Multiple-Baseline Designs , 2002 .

[21]  R. D. de Bie,et al.  Non-pharmacological care for patients with generalized osteoarthritis: design of a randomized clinical trial , 2010, BMC musculoskeletal disorders.

[22]  Matthew K Nock,et al.  Single-case experimental designs for the evaluation of treatments for self-injurious and suicidal behaviors. , 2008, Suicide & life-threatening behavior.

[23]  K. Lorig,et al.  Arthritis Self-Efficacy Scales measure self-efficacy. , 1998, Arthritis care and research : the official journal of the Arthritis Health Professions Association.

[24]  S. van der Linden,et al.  A review of instruments to assess illness representations in patients with rheumatic diseases , 2009, Annals of the rheumatic diseases.

[25]  P Tugwell,et al.  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. , 2010, Osteoarthritis and cartilage.

[26]  A. Ismaila,et al.  A tutorial on pilot studies: the what, why and how , 2010, BMC Medical Research Methodology.

[27]  R. Glasgow,et al.  Assessing delivery of the five 'As' for patient-centered counseling. , 2006, Health promotion international.

[28]  G H Guyatt,et al.  The n-of-1 randomized controlled trial: clinical usefulness. Our three-year experience. , 1990, Annals of internal medicine.

[29]  P. Richette,et al.  Prevalence of generalized osteoarthritis in a population with knee osteoarthritis. , 2011, Joint, bone, spine : revue du rhumatisme.

[30]  Martin Underwood,et al.  Osteoarthritis: national clinical guideline for care and management in adults , 2008 .

[31]  Nell K. Duke,et al.  Literacy research methodologies , 2005 .

[32]  J. Dekker,et al.  A multidisciplinary and multidimensional intervention for patients with hand osteoarthritis , 2012, Clinical rehabilitation.

[33]  P Tugwell,et al.  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. , 2007, Osteoarthritis and cartilage.

[34]  M. Petticrew,et al.  Developing and evaluating complex interventions: the new Medical Research Council guidance , 2008, BMJ : British Medical Journal.

[35]  R. Schwarzer,et al.  The General Self-Efficacy Scale: Multicultural Validation Studies , 2005, The Journal of psychology.

[36]  P Tugwell,et al.  OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. , 2008, Osteoarthritis and cartilage.

[37]  J. Vlaeyen,et al.  Pain-related fear, perceived harmfulness of activities, and functional limitations in complex regional pain syndrome type I. , 2011, The journal of pain : official journal of the American Pain Society.

[38]  C Kent Kwoh,et al.  Low back pain and other musculoskeletal pain comorbidities in individuals with symptomatic osteoarthritis of the knee: Data from the osteoarthritis initiative , 2010, Arthritis care & research.

[39]  R. D. de Bie,et al.  Joint‐pain comorbidity, health status, and medication use in hip and knee osteoarthritis: A cross‐sectional study , 2012, Arthritis care & research.

[40]  F. Aizpuru,et al.  Patient acceptable symptom state and OMERACT-OARSI set of responder criteria in joint replacement. Identification of cut-off values. , 2012, Osteoarthritis and cartilage.

[41]  Deborah Ashby,et al.  Lessons for cluster randomized trials in the twenty-first century: a systematic review of trials in primary care , 2004, Clinical trials.

[42]  H. Holman,et al.  Measurement of patient outcome in arthritis. , 1980, Arthritis and rheumatism.

[43]  Changes associated with a quota-based approach on a walking program for individuals with fibromyalgia. , 2007, The Journal of orthopaedic and sports physical therapy.

[44]  D. Rhon,et al.  Re: Zhang W, Moskowitz RW, Nuki G, et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage 2008;16:137-62. , 2008, Osteoarthritis and cartilage.