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Clinical and epidemiological research
Extended report
Effect of assistive technology in hand osteoarthritis: a randomised controlled trial
  1. Ingvild Kjeken1,
  2. Siri Darre2,
  3. Geir Smedslund1,
  4. Kåre Birger Hagen1,
  5. Randi Nossum2
  1. 1National Resource Center for Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway
  2. 2Department of Rheumatology, St Olav's Hospital, Trondheim, Norway
  1. Correspondence to Ingvild Kjeken, National Resource Center for Rehabilitation in Rheumatology, Diakonhjemmet Hospital, PO Box 23, Vinderen, NO-0319 Oslo, Norway; ingvild.kjeken{at}diakonsyk.no

Abstract

Objective Hand osteoarthritis (HOA) is a common joint disorder with an expected rise in prevalence due to the increasing ageing population, but with few available effective treatment options. The main aim of this study was to evaluate the effect of assistive technology (AT) in patients with HOA.

Methods In this observer-blinded, randomised controlled trial, 35 patients with HOA (AT group) received provision of information and AT (assistive devices and splints), while 35 patients received information only (control group). Primary outcomes were activity performance and satisfaction with performance, measured by the Canadian occupational performance measure (COPM) on a 1–10 scale. Secondary outcomes included measures of disease activity, pain, fatigue and function. Outcome assessments were made at 3 months follow-up.

Results Of 70 participants randomised, 66 participants completed all assessments. Provision of AT was associated with improvement in the COPM performance score (mean difference (95% CI) in change scores 1.8 (1.1 to 2.6) and in the satisfaction score (1.7 (0.7 to 2.6)), indicating a moderate to large treatment effect (effect sizes 0.9). There was a significant improvement in the Australian/Canadian hand index function score in the AT group after 3 months (−0.4, p<0.001), and an adjusted mean difference between groups of −0.3 (p=0.06, effect size −0.5). No other differences were found in the secondary outcomes. Self-reported AT usage rate in the AT group was 92%, and participants rated their comfort with AT usage as high.

Conclusions Use of AT is well tolerated and significantly improves activity performance and satisfaction with performance in patients with HOA.

The trial is registered in the ISRCTN register (ISRCTN40357804).

http://dx.doi.org/10.1136/ard.2010.148668

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    Hand osteoarthritis (HOA) is one of the most prevalent joint disorders, affecting the distal and proximal interphalangeal joints, and first carpometacarpal (CMC1) and interphalangeal joints.1 Functional consequences of HOA are pain, reduced hand strength and mobility, and activity limitations and participation restrictions.1,–,3 Change of physical appearance, loss of activities, and a feeling of lack of mastery may again lead to changes in roles and self-identity.3

    Currently, there is no cure for HOA, pharmacological treatment is mostly symptomatic, and surgical treatment is limited to severe CMC1-OA. The European League Against Rheumatism states that optimal management of HOA requires a combination of non-pharmacological and pharmacological treatment modalities, which should be tailored according to the patient's requirements and expectations, as well as to his/her level of pain, disability and restriction of quality of life.4 Use of assistive technology (AT) is a common strategy to improve activity and participation, and a frequent self-management strategy among persons with osteoarthritis, including HOA.3 5,–,9 AT is defined as ‘any item, piece or equipment, or product system whether acquired commercially off the shelf, modified or customised, that is used to increase, maintain, or improve functional capabilities of individuals with disabilities’.10 It includes a wide range of products, from low-tech devices to technologically complex equipment, and also orthoses or splints.10,–,12 While some are designed for the general population, others are developed to meet the needs of people with functional limitations.

    In a systematic review of non-surgical therapies for HOA, the authors conclude that there is some evidence for the efficacy of splints for CMC1-OA.13 Since then, two randomised controlled trials (RCT) of splints for CMC1-OA have been published. The results support that wearing a splint improves pain14 15 and disability.14 Use of AT other than splints have been evaluated in one RCT and one controlled study, both examining the effect of joint protection.5 6 In both studies joint protection showed positive effects. However, the joint protection programmes included hand exercises and the control groups also received AT. Thus, no conclusions concerning the specific effect of AT can be drawn.

    The main aim of this study, therefore, was to evaluate the effect of AT in patients with HOA.

    Methods

    Study design

    In this RCT, participants were assessed at baseline (before group allocation) and after 3 months by an occupational therapist (OT). Two patient research partners participated in planning of the study, including suggesting additional research questions, discussing outcomes and time interval between baseline and control, formulating the patient information sheet and ensuring a patient-friendly design. The study was approved by the Regional Committee for Medical Research Ethics and the Data Inspectorate, and all patients consented to participate.

    Study participants

    From March 2008 to January 2010, a total of 70 participants with HOA diagnosed by a rheumatologist or an orthopaedic surgeon according to the criteria of the American College of Rheumatology16 were consecutively included at outpatient clinics at St Olav's Hospital in Trondheim, Norway, by two OTs (SD and RN) working at the department of rheumatology. Other inclusion criteria were minimum two self-reported activity limitations caused by HOA, age less than 80 years and ability to communicate in Norwegian. Exclusion criteria were hand surgery within the past 6 months or changes in medication within the past month, impaired hand function due to trauma or diseases other than HOA, or cognitive or mental impairment. Participants who underwent hand surgery during the trial period or who had changed medication within the past month were excluded at the control at 3 months.

    Randomisation and procedures

    Patients were randomly assigned to the intervention (provision of AT and information) or control group (information only). A statistician not involved in the study made a computer-generated randomisation list, with a block size of 10. Concealed, opaque envelopes prepared by a secretary were used to allocate the patients to either the intervention or the control group. The envelopes were stored in a locked closet and were opened by the OT (SD) after baseline assessments and information of HOA were completed. In this trial, patients and the therapist delivering the intervention (SD) were aware of the treatment assigned. However, to achieve observer blinding, patients were asked not to inform the assessor (RN) about their group allocation in the posted appointment for 3 months assessments.

    Intervention

    As part of baseline assessments, the patient-specific measure Canadian occupational performance measure (COPM) was used to identify activity limitations.17 After assessments, both groups received information about HOA, and a leaflet containing three hand exercises and five suggestions for alternative working methods to improve hand function and performance of daily activities (see supplementary file, available online only). The intervention group additionally received provision or recommendation of AT (assistive devices and/or splints). The activity limitations identified in the COPM interview gave directions for the choice of AT, and provision of AT was based on the human activity assistive technology model, taking both the person, the activity, the AT and the context into consideration.18 Depending on the problems described by the patient, the intervention could also include teaching of energy conservation and alternative working methods, in which use of AT was part of the working method.19 Both groups received medical treatment as usual, including use of medication due to their HOA. In Norway, expenses for splints and a selection of assistive devices for people with functional limitations caused by a chronic condition are covered by the state. Thus, participants in the AT group were offered help to apply for economic support for some of the recommended AT, to which all consented. The control group received AT after completion of the study.

    Assessments

    The primary outcome in the trial was activity and participation, assessed with the COPM. The rationale for this is that AT is designed to improve function in one or a few activities. Therefore, the effect is to a large degree activity-specific, with little influence on other activities or on disease activity and function in general. As the COPM was used to ensure congruence between patients' activity limitations, therapy priorities, provision of AT and evaluation, we expected the COPM to be more responsive than the standardised measures to capture changes in activity performance caused by AT.17 Our main hypothesis was that there would be significant differences between the two groups after 3 months with regards to the COPM scores, and little or no differences in the other measures of symptoms and function.

    The COPM assessment started by an interview, addressing patient-specific HOA-related activity limitations within nine areas: personal care; functional mobility; community management; (self-care); paid/unpaid work; household management; play/school; (productivity); and quiet recreation, active recreation and socialisation (leisure).17 Each activity in which the patient reported a limitation was written down under one of the activity categories in the COPM test form. The patient thereafter rated the importance of each activity on a 1–10-point scale, before the five most important activities were rated for performance and satisfaction with performance, again on 1–10-point scales (higher scores reflect better performance or higher satisfaction). The Norwegian version of the COPM has been tested for validity, reliability and responsiveness and has demonstrated good ability to detect functional changes in HOA.20 21

    Secondary outcomes were pain, fatigue and disease activity, measured on visual analogue scales (VAS), self-reported hand function assessed with the three dimensions pain (five items), stiffness (one item) and physical functioning (nine items) of the Australian/Canadian hand index (AUSCAN) on five-point Likert scales,22 and overall disability measured by the modified health assessment questionnaire, comprising eight items addressing activity and participation with a score ranging from 0 to 3.23

    To assess disease severity, the CMC1, metacarpophalangeal, distal and proximal interphalangeal joints in both hands were examined by the same trained OT (SD) for the presence of bony enlargement (1: present, 0: absent) at baseline. Joint counts were computed as a summary of manifestations for both hands (range 0–30). As studies indicate that levels of pain and disability are significantly higher among patients with CMC1 involvement, the presence of radiological CMC1-OA was also recorded.24 25

    Possession, use of and comfort with AT at baseline and after 3 months were reported by participants in a questionnaire with 38 specified devices and splints, and with possibilities for adding AT not listed. Comfort with AT use was self-reported on a 100-mm VAS scale.26 For all descriptive and secondary outcome measures, higher scores reflect worse health status or less comfort.

    Sample size

    The smallest detectable difference in COPM performance scores has been reported as 1.47,21 and in the COPM manual, a change of 2.0 points is suggested as a clinically relevant change.17 Based on results from a previous study,20 we calculated that a sample size of 35 patients for each group was required to detect a difference of 2 points, with a significance level of 0.05 and a power of 80%, assuming that the SD of the COPM performance score was of 1.59 in both groups, and an expected 20% loss to follow-up after 3 months.

    Statistical analyses

    Analysis was performed on an intention-to-treat basis. Differences at baseline between participants in the two treatment groups were examined by independent samples t test for means and χ2 for proportions. Within-group differences were examined by paired samples t test. Analysis of covariance was used to estimate between-group differences at 3 months follow-up, with scores at 3 months as dependent variable, taking baseline values as covariates.27 Furthermore, treatment effect sizes (Cohen's d) were computed as the adjusted between-group difference in scores divided by the pooled SD of the baseline scores for this outcome.28

    Results

    Study participants

    A total of 162 consecutive patients were invited to participate in the study, of which 29 refused to participate (figure 1).

    Figure 1
    Figure 1

    Flow of participants through the trial.

    Of the 133 persons that were assessed for eligibility, 63 were excluded, while the remaining 70 were randomly assigned into receiving information and AT (AT group) (n=35), or to receiving information only (control group) (n=35). The 92 non-participants were significantly older than the participants (mean age 62.1 and 60.5 years, p=0.02), and the proportion of men was higher (13/92 vs 2/70, p=0.07). Three participants in the AT group and one in the control group were excluded before follow-up assessments due to surgery in the CMC1 joint.

    The baseline characteristics of participants were well matched between the two groups, except for a trend towards a lower (poorer) mean COPM performance score (5.2 vs 6.2, p=0.07) in the AT group (table 1).

    View this table:
    Table 1

    Baseline characteristics in 70 hand osteoarthritis patients randomly assigned to both information and AT (AT group) or information only (control group), reported as number and proportions, or mean values and SD

    Use of medication at baseline and in the trial period was similar and stable in both groups (table 2).

    View this table:
    Table 2

    Medication at baseline and after 3 months in 70 hand osteoarthritis patients randomly assigned to information and AT (AT group) or information only (control group)

    At baseline, 15 participants in the AT group reported having a total of 30 devices and four splints, compared with 19 participants in the control group reporting a total number of 47 devices and two splints (p=0.38). In the AT group, 88% of the AT were used regularly or when having pain, compared with 96% in the control group. Median VAS scores for comfort with AT use were 4.2 in the AT group and 4.5 in the control group (p=0.92).

    In the COPM interviews, the participants reported a total of 646 activity limitations and prioritised 345 out of these. The problems represented a wide variety of activities, most often related to dressing, food making, opening of packaging, cleaning, gripping and holding, and writing by hand (figure 2).

    Figure 2
    Figure 2

     Number of self reported (black staples) and prioritised (grey staples) activity limitations in 70 participants with hand osteoarthritis as assessed with the Canadian occupational performance measure (COPM). Activities described by 10 or more participants are listed under each activity category along with described and prioritised frequency.

    Interventions

    Of the 35 participants in the AT group, all but one received technical devices, and 26 received splints. The AT provided were mainly smaller devices for personal care, house work and leisure, such as knives and scissors with ergonomic handles, openers for packaging, ergonomic pens and semirigid prefabricated splints supporting the CMC joint. The total number of devices provided was 347, with a median number of 11 (range 1–17), while eight participants received a splint for their right hand, five for their left hand and 13 for both hands (total 39). Median time use per participant for completion of baseline assessments were approximately 60 min, plus 35 min for information about HOA. Median time for provision of AT was 30 min (AT group only), while median time for paperwork was 15 min in the AT group and 10 in the control group. The AT intervention was completed in one session in all but three participants, who came back for a second session. Self-reported possession of the 12 most frequent AT at 3 months is displayed in figure 3, together with numbers in use after 3 months in the AT group.

    Figure 3
    Figure 3

     Possession and use of assistive technology (AT) after 3 months in 32 patients randomly assigned to provision of assistive technology and information. Numbers of possessed AT in the control group (information only, n=34) are given at the bottom of each staple.

    The total number of self-reported AT after 3 months were 330 in the AT group and 26 in the control group, while reported numbers of AT in use were 303 (91.8%) and 25 (96.2%), respectively. The most frequent reported reason for non-use was that the device or splint was not functional. Median score for comfort with AT use was 5.7 in the AT group and 3.1 in the control group (p=0.19).

    Primary outcomes

    There were significant positive changes in the COPM performance and satisfaction scores (mean changes 1.4, p=0.003 and 2.5, p<0.001, respectively) in the AT group after 3 months, and a significant negative change in the COPM performance scores in the control group (mean change −1.0, p=0.005) (table 3).

    View this table:
    Table 3

    Effect of AT in 70 patients randomly assigned to AT and information (AT group) or information only (control group)

    The initial hypotheses regarding the effect of AT in HOA were confirmed, as provision of AT predicted improvement in the COPM performance and satisfaction scores (mean adjusted differences in change between groups 1.8, p<0.001 and 1.7, p=0.001, and effect sizes 0.9 and 0.9, respectively) (table 3).

    Secondary outcomes

    There was a significant positive improvement in the AUSCAN function scores (mean change −0.4, p<0.001) in the AT group after 3 months, and the mean adjusted difference in change between groups was close to statistical significance (mean difference −0.3, p=0.06) with an effect size of −0.5. Changes in all other secondary outcome variables were small and non-significant.

    Discussion

    To our knowledge, this study is one of very few RCT assessing the effect of AT,29 and the first assessing AT in HOA.13 The results demonstrate that the use of AT significantly improves activity performance and satisfaction with performance in patients with HOA.

    In a recent study, limitations in daily activities were the major determinant of reduced health-related quality of life in patients with HOA,30 and currently, few other interventions substitute for well designed and efficient AT. More studies are, however, needed to conclude if standard management of HOA should include information and/or provision of AT, and to examine the cost-effectiveness of this intervention.

    It is often claimed that AT usage rates are low, and the reported regular usage of AT in persons with arthritis varies considerably.8 26 31 In this study, usage rates mostly exceeded 90%, and participants rated their comfort with AT usage as high. The results thereby support the use of AT as an effective and accepted strategy to improve activity performance among persons with HOA. Involving participants in selecting AT that matched their activity limitations probably contributed to the high usage rate.32 33 However, future studies should also investigate possible harmful effects of AT use.

    The most frequent activity limitations described by study participants were related to personal care, household management and leisure. The same problems are reported in earlier HOA studies,3 20 34 and by people with other rheumatic35 36 and neurological diseases.37 38 These results underline the need for the development of products that are accessible and beneficial for people of all ages and abilities. The principles of universal design and consumer involvement should be used to guide such development to ensure a user-friendly design.39

    In a call for new strategies within research in HOA, Kloppenburg and colleagues40 argue that researchers need to broaden the concept of function also to include participation in daily life as a key concept relevant to patients. They further state that ‘the ability to perform a given task in a daily life situation may be more important to a patient than their ability to perform a specified task item in a test situation or on a questionnaire, which may not be at all important to that particular patient’. In this study, we used a patient-specific measure to ensure congruence between patients' needs, therapy priorities, interventions and evaluation. Thus, our research hypothesis was that there would be significant differences between the two groups after 3 months with regard to the COPM scores, but little or no differences in the other measures of symptoms and function. The results confirm the hypothesis, and demonstrate that the use of patient-specific measures may promote patient-centred interventions and increase the possibility of detecting clinically relevant outcomes.

    In our study, there was a trend towards poorer baseline COPM scores in the AT group. We therefore used analysis of covariance to compare changes at 3 months. This procedure adjusts each patient's follow-up score for his/her baseline score, and has the advantage of being unaffected by baseline differences, thereby avoiding under or overestimating any treatment effect.27 However, these analyses are conservative, as secondary unadjusted analysis in general resulted in larger effect estimates, and with a significant (p=0.005) difference between groups in the AUSCAN function scores after 3 months.

    A limitation with our study design is that, as with most non-pharmacological treatments, it was impossible to carry out a double-blind study because both participants and therapist knew which therapy they received or delivered. We tried to maintain masked conditions for assessment by asking patients not to reveal group allocation to the assessor at the 3 months follow-up. It would, however, have strengthened the study to register the success rate of this strategy by asking the assessor whether or not she had guessed the group allocation of each participant after the assessments were completed. Furthermore, the envelopes revealing group allocation should ideally have been opened by a person not involved in the trial. However, all outcomes were self-reported using validated measures, thereby reducing the chance of results being greatly affected by observer bias.

    Also, the sample might not be representative of all patients with HOA, as there were few male participants, and all participants were recruited from the outpatient clinics of a university hospital and thus probably had more aggravated symptoms and functional limitations. This strategy was, however, necessary to achieve uniformity in terms of screening and diagnosis to facilitate comparison with other studies. The possibility of economic support may also have contributed to more acquisition and use of AT. The size of the effects combined with the modest time used for delivering the intervention is, however, promising. Furthermore, AT is increasingly accessible for purchase by the public both on the high street and over the internet. Acquisition and use of AT is therefore an easily available self-management strategy for people with HOA.

    In conclusion, the use of AT is well tolerated and significantly improves activity performance and satisfaction with performance in patients with HOA.

    Acknowledgments

    The authors would like to thank the patient research partners Anne Frigstad and Hilde Seip for their valuable input when planning the study, and the trial participants for their time and effort.

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    Supplementary materials

    Footnotes

    • Funding Financial support for the study was provided by the Norwegian Occupational Therapy Association and by Oslo Revmatikerforening.

    • Competing interests None.

    • Patient consent Obtained.

    • Ethics approval The study was conducted with the approval of the Norwegian Regional Committee for Medical Research Ethics and the Data Inspectorate.

    • Provenance and peer review Not commissioned; externally peer reviewed.