The goal of occupational therapy (OT) is to provide disease information, facilitate a positive attitude and teach strategies for self-management. Patients with rheumatoid arthritis (RA) show a reduction in physical capacities. Long-term OT has shown evidence of joint protection1 and is effective in all stages of RA disease.2 However, OT programmes associated with splints have rarely been evaluated in early RA. Few randomised controlled trials have demonstrated OT efficacy,3^–5 and only one study included splinting.1 Only a few studies have focused on static resting splints, and were not performed in early RA.6 7 However, recent reviews8 9 have concluded that there is no evidence to support the use of splints in early RA.

As for every assessment, function can be assessed in numerous ways. Among those, grip strength of hands is an essential objective assessment of hand function, because many daily activities require considerable hand strength, (eg, opening doors, opening jar lids, lifting and carrying heavy items, etc.).10 Hand grip strength is almost 75% lower in patients with RA than in healthy controls.11 In addition, the Health Assessment Questionnaire (HAQ) score represents a subjective assessment of function. Accordingly, these two markers were used here to evaluate the efficiency of an OT programme on hand function in early RA using a randomised, blind, controlled study.

PATIENTS AND METHODS

Patients

A total of 60 patients with early RA were recruited from our unit from April 2002 to June 2005 and randomised into 2 groups. Patients had RA according to the American College of Rheumatology (ACR) criteria and early disease (duration less than 2 years). Patients were excluded if they had an RA duration over 2 years, depression, were unable to contribute, or had been exposed to a previous OT programme.

Trial design

This study was a 3-month monocentric, randomised, blind, controlled trial of a full OT programme. After screening and baseline assessment, patients were randomised into 2 groups: group 1 (n = 30) received the full OT programme at baseline and group 2 (n = 30) was not exposed to the OT programme during the first 3 months. The primary and secondary outcomes were assessed at 3 months. Then, group 2 received the full OT programme in a 3-month open-label extension phase and was evaluated at 6 months (fig 1). The multidisciplinary team consisted of a senior rheumatologist, a nurse, a kinesitherapist, an occupational therapist, a dietician and a social worker, all trained in delivering this programme. During a half-day session at the hospital, education and practice regarding joint protection with hand and wrist exercises were provided. Modalities consisted of watching a video cassette, comprehensive OT, training in motor function, training in skills, instruction on joint protection, counselling, advice, and instruction in the use of assistive devices, provision of splints, and education and psychosocial support. The kinesitherapist met each patient, insisting on practice regarding joint protection, hand and wrist exercises with provision of a booklet. Patients were encouraged to repeat OT exercises at least twice a day. The occupational therapist gave advice on technical help if needed and manufactured splints (in low temperature thermoplastic and positioned with the forearm in prone position) for the prevention of joint deformation. Patients were advised to wear their splints during rest periods, including at night.

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Figure 1 Trial profile of an occupational therapy programme in early rheumatoid arthritis.

Outcome measures

The primary outcome was dominant hand grip strength (Martin Vigorimeter, an air dynamometer providing pressure values in kPa; Gebrüder Martin, Tuttlingen, Germany)12 at 3 months. Secondary outcomes were non-dominant hand grip strength, HAQ score and satisfaction with care and compliance rates. Evaluations were performed without wearing splints. The same person conducted all of the assessments. The satisfaction of care used a verbal scale: no satisfaction, indifference, satisfied, very satisfied (data were separated with the threshold between satisfied and very satisfied). Compliance for use of hand splints and performance of daily OT exercises (using dichotomised variables: yes or no) were also recorded.

Statistical analysis

The effect of the OT programme was compared separately at 3 months and 6 months. Changes from baseline to 3 months for group 1 and from 3 months to 6 months for group 2 were analysed using analysis of covariance (ANCOVA), with an effect for treatment on grip strength or HAQ score as dependent variable, and their respective baseline values and treatment group as covariates. All analyses were performed using SPSS V.12.0.1 software (SPSS, Chicago, Illinois, USA). An intention to treat analysis was conducted. Results are expressed as the mean (SD). The sample size per group was determined according to a difference of at least 15 kPa in dominant grip strength between both groups at 3 months with an SD at 30 kPa, a type I risk of 0.05 and a power of 90%. Using this hypothesis, 30 patients were needed per group. Accordingly, 30 patients were recruited in each group.

RESULTS

Characteristics of patients at baseline and comparison at 3 months

A total of 60 patients with early RA were enrolled (table 1); 23 patients in group 1 attended the full OT programme. Almost all patients (28/30) were very satisfied with the given information, but only 57% of patients carried their hand splints. No patients from group 2 received the OT programme, as according to the protocol. Because they requested them, two patients in group 2 received splints during the first 3 months. They were kept in group 2 for the analysis. At 3 months (table 2), patients in group 1 had a higher increase of grip strength for the dominant hand and non-dominant hand (p = 0.021 and 0.047 respectively), and had a higher decrease of HAQ score than patients in group 2 (p<0.001).

Comparison between the two groups after 3-month extension phase (table 2)

In the open phase, at 3 months group 2 followed the same full OT programme as group 1 at baseline. Data from group 2 between 3 to 6 months were compared to data from group 1 between baseline to 3 months. In group 2, 87% of patients attended the full programme compared to 76% of patients in group 1 (p = 0.31). After they had been informed, 97% of patients in group 2 were very satisfied at the same level as patients in group 1 (97% vs 93%; p = 0.55). In group 2, 85% of patients used their hand splints; more often than patients in group 1 (57%; p<0.001). However, only 40% of the patients in group 2 were practicing self-rehabilitation exercises compared to 90% in group 1 (p<0.001).

Interestingly, patients in group 2 improved their dominant hand grip strength after 3 months of OT at 6 months as did patients in group 1 during the 3 first months of the study (p = 0.072). Similarly for the non-dominant hand, the increase of grip strength was the same during the 3 months following the OT programme (p = 0.776). In the same way, the HAQ score in group 2 also significantly diminished at 6 months as it had diminished in group 1 at 3 months (p = 0.674).

DISCUSSION

In this study, we observed that an OT programme associated with provision of splints is effective on grip strength and also on HAQ score. Few studies have simultaneously evaluated an OT programme and provision of wrist splints. In early RA, this is the first trial that has observed a positive effect on grip strength induced by an OT programme at 3 months. However, two other randomised studies performed at an early stage of RA failed to observe an effect on objective assessment such as grip strength.13 14 However, in these studies the grip strength was assessed at 6 and/or 12 months. Another way to explain this difference is the benefits of the drugs used at an early stage. In our study, to avoid such confounding effects, the study was a monocentric study and all patients received the same disease-modifying antirheumatic drug (DMARD) (methotrexate), in combination with anti-tumour necrosis factor (TNF)α in only 10% (with similar repartition in both groups) according to local guidelines. The final difference was the nature of the intervention. Here, the OT programme included splints and did not focus on provision of wrist splints vs no information, whereas the other studies focused on two levels of information13 or splinting.14 In line with the objective improvement, we also observed an effect on subjective assessment using the HAQ score. However, in a previous study, more information was not able to improve HAQ score over 2 years in early RA.13 In early RA, longitudinal studies showed that functional ability does not significantly decrease in the first 5 years.15 This could explain why patients in group 2 reached the same grip strength despite receiving the information 3 months later.

Despite new, effective drugs, early OT programmes may have their own importance in improving early RA. This study concluded that an OT programme improved the function of both hands. Accordingly, rheumatology departments should provide early OT programmes to everyone with early RA. Long-term follow-up studies (5–10 years) are essential to evaluate whether these interventions can truly be preventive, in conjunction with the effects of drug treatment.