Effectiveness of sensorimotor training in patients with rheumatoid arthritis: a randomized controlled trial

The objective of this study was to evaluate the effectiveness of a sensorimotor training in patients with rheumatoid arthritis on the improvement of functional skills and quality of life, a double-blinded, prospective, randomized controlled trial. One hundred two participants with rheumatoid arthritis were selected. After the baseline evaluation, the participants were randomized to two different groups: sensorimotor group (2 sessions per week, 30–50 min each session, besides continuing taking the same drugs as the control group) and control group (control group was only submitted to the clinical drug treatment with Methotrexate, Leflunomide and/or Prednisone (5 mg), being then evaluated 4 months later). Functional capacity [Health Assessment Questionnaire (HAQ) and Timed Up & Go Test (TU&GT)], Balance and Gait (Berg Balance Scale (BBS) and Tinetti Test) and Quality of Life (Short Form Health Survey—SF-36). The study had been concluded with ninety-one participants, and a statistically significant improvement was found in all variables assessed: HAQ (P < .01), TU&GT (P < .01), BBS (P < .01), Tinetti Test (P < .01) and improvement in the subscales of SF-36 (P < .01) in the sensorimotor group in comparison with the baseline evaluation and control group. No significant difference was found related to the pre- and post-evaluation in the control group. Therefore, the sensorimotor training is effective in the improvement of the functional capacity and quality of life of patients with rheumatoid arthritis.     

Adalimumab response in patients with early versus established rheumatoid arthritis: DE019 randomized controlled trial subanalysis

In recent years, there has been a shift in the therapeutic approach to rheumatoid arthritis (RA), with emphasis on early therapy. The DE019 trial demonstrated adalimumab efficacy in patients with RA. This subanalysis compares response to adalimumab based on clinical, functional, and radiographic outcomes in patients with early versus established RA. Patients enrolled in the DE019 trial were divided into two groups based on disease duration (≤3 years = early RA; >3 years = established RA). Data from 407 patients with RA were included, with 78 early (41 adalimumab, 37 placebo) and 329 established (166 adalimumab, 163 placebo) patients. Patients with early disease achieved slightly greater American College of Rheumatology 20 (20% or more improvement or ACR20), 50, and 70 responses of 61%, 46.3%, and 24.4%, respectively, at 52 weeks, compared with those with established disease, with ACR20, 50, and 70 responses of 56%, 37.3%, and 19.9%, respectively. The Health Assessment Questionnaire score improvement between adalimumab and placebo in patients with early disease (0.44) was greater than that for those with established disease (0.25). With adalimumab treatment, there was a statistically significant mean reduction in total Sharp score progression relative to placebo (5.32) in early disease compared with established disease (2.06). While adalimumab is effective for RA of all disease durations, there is a trend toward superior clinical, functional, and radiographic outcomes in patients with early disease.     

A randomized controlled trial of homeopathy in rheumatoid arthritis

OBJECTIVE: To test the hypothesis that homeopathy is effective in reducing the symptoms of joint inflammation in rheumatoid arthritis (RA). METHOD: This was a 6-month randomized, cross-over, double-blind, placebo-controlled, single-centre study set in a teaching hospital rheumatology out-patient clinic. The participants of the study were 112 patients who had definite or classical RA, were seropositive for rheumatoid factor and were receiving either stable doses of single non-steroidal anti-inflammatory drugs (NSAIDs) for > or =3 months or single disease-modifying anti-rheumatic drugs (DMARDs) with or without NSAIDs for > or =6 months. Patients who were severely disabled, had taken systemic steroids in the previous 6 months or had withdrawn from DMARD therapy in the previous 12 months were excluded. Two series of medicines were used. One comprised 42 homeopathic medicines used for treating RA in 6cH (10(-12)) and/or 30cH (10(-30)) dilutions (a total of 59 preparations) manufactured to French National Pharmacopoeia standards, the other comprised identical matching placebos. The main outcome measures were visual analogue scale pain scores, Ritchie articular index, duration of morning stiffness and erythrocyte sedimentation rate (ESR). RESULTS: Fifty-eight patients completed the trial. Over 6 months there were significant decreases (P<0.01 by Wilcoxon rank sum tests) in their mean pain scores (fell 18%), articular indices (fell 24%) and ESRs (fell 11%). Fifty-four patients withdrew before completing the trial. Thirty-one changed conventional medication, 10 had serious intercurrent illness or surgery, 12 failed to attend and three withdrew consent. Placebo and active homeopathy had different effects on pain scores; mean pain scores were significantly lower after 3 months' placebo therapy than 3 months' active therapy (P=0.032 by Wilcoxon rank sum test). Articular index, ESR and morning stiffness were similar with active and placebo homeopathy. CONCLUSIONS: We found no evidence that active homeopathy improves the symptoms of RA, over 3 months, in patients attending a routine clinic who are stabilized on NSAIDs or DMARDs.     

Optimization of flare management in patients with rheumatoid arthritis: results of a randomized controlled trial

Clinical Rheumatology - To evaluate the effect of a flare management intervention guided by non-physician providers versus usual care between rheumatology visits on flare occurrence and rheumatoid...     

A randomized and controlled trial of hydrotherapy in rheumatoid arthritis

Objective . The aim of this study was to evaluate the therapeutic effects of hydrotherapy which combines elements of warm water immersion and exercise. It was predicted that hydrotherapy would result in a greater therapeutic benefit than either of these components separately. Method . One hundred thirty-nine patients with chronic rheumatoid arthritis were randomly assigned to hydrotherapy, seated immersion, land exercise, or progressive relaxation. Patients attended 30-minute sessions twice weekly for 4 weeks. Physical and psychological measures were completed before and after intervention, and at a 3-month followup. Results . All patients improved physically and emotionally, as assessed by the Arthritis Impact Measurement Scales 2 questionnaire. Belief that pain was controlled by chance happenings decreased, signifying improvement. In addition, hydrotherapy patients showed significantly greater improvement in joint tenderness and in knee range of movement (women only). At followup, hydrotherapy patients maintained the improvement in emotional and psychological state. Conclusions . Although all patients experienced some benefit, hydrotherapy produced the greatest improvements. This study, therefore, provides some justification for the continued use of hydrotherapy.     

Patient-controlled outpatient follow-up on demand for patients with rheumatoid arthritis: a 2-year randomized controlled trial

Clinical Rheumatology - Scheduled routine visits in patients with rheumatoid arthritis (RA) may be in a stable period without active disease. Consequently, there is a demand for developing...     

A randomized controlled trial of foot orthoses in rheumatoid arthritis

OBJECTIVE: To investigate the clinical effectiveness of early foot orthosis intervention for painful correctable valgus deformity of the rearfoot in rheumatoid arthritis (RA). METHODS: Patients with RA were randomized to receive custom manufactured rigid foot orthoses under podiatry supervision (n = 50) or enter a control group (n = 48). The control group received foot orthoses only when prescribed under normal medical care. Foot pain and disability, using the Foot Function Index (FFI), along with disease activity, tolerance, and adverse reactions, were serially measured over 30 mo continuous treatment. RESULTS: The group assigned foot orthoses demonstrated an immediate clinical improvement, the effect peaking at 12 mo. At 30 mo the FFI total score was reduced by 23.1% from baseline in the intervention group. Area under the curve analysis showed a statistically significant reduction in FFI scores for total score (p = 0.026), foot pain (p = 0.014), and foot disability (p = 0.016) when intervention was compared to control scores. There were no confounding effects from differences between groups for disease activity or pharmacological or other management strategies. Most patients (96%) used their orthoses and most found them comfortable (97%), although minor adverse reactions, such as tender spots, blisters, and callus, were reported in 30% of patients in the early stages of treatment and persisted in 12% for 30 mo. CONCLUSION: Custom designed foot orthoses used continuously over a 30 mo treatment period resulted in a reduction in foot pain by 19.1%, foot disability by 30.8%, and functional limitation by 13.5%. Clinical effectiveness might be enhanced by their use in the early stages of rearfoot pain and deformity.     

Benefits of exercise in patients with rheumatoid arthritis: a randomized controlled trial of a patient-specific exercise programme

Clinical Rheumatology - Patients with rheumatoid arthritis (RA) tend to be more overweight, take less physical exercise, exhibit decreased cardiorespiratory fitness and demonstrate reduced muscle...     

Debridement of plantar callosities in rheumatoid arthritis: a randomized controlled trial

OBJECTIVE: To compare forefoot pain, pressure and function before and after normal and sham callus treatment in rheumatoid arthritis (RA). Patients and METHODS: Thirty-eight RA patients were randomly assigned to normal (NCT group) or sham (SCT) scalpel debridement. The sham procedure comprised blunt-edged scalpel paring of the callus which delivered a physical stimulus but left the hyperkeratotic tissue intact, the procedure being partially obscured from the patient. Forefoot pain was assessed using a 100 mm visual analogue scale (VAS), pressure using a high-resolution foot pressure scanner and function using the spatial-temporal gait parameters measured on an instrumented walkway. Radiographic scores of joint erosion were obtained for metatarsophalangeal (MTP) joints with and without overlying callosities. The trial consisted of a randomized sham-controlled phase evaluating the immediate same-day treatment effect and an unblinded 4-week follow-up phase. RESULTS: During the sham-controlled phase, forefoot pain improved in both groups by only 3 points on a VAS and no statistically significant between-group difference was found (P = 0.48). When data were pooled during the unblinded phase, the improvement in forefoot pain reached a peak after 2 days and gradually lessened over the next 28 days. Following debridement, peak pressures at the callus sites decreased in the NCT group and increased in the SCT group, but there was no statistically significant between-group difference (P = 0.16). The area of and duration of contact of the callus site on the ground remained unchanged following treatment in both groups. Following debridement, walking speed was increased, the stride-length was longer and the double-support time shorter in both groups; however, between-group differences did not reach levels of statistical significance. MTP joints with overlying callus were significantly more eroded than those without (P = 0.02). CONCLUSIONS: Treatment of painful plantar callosities in RA using scalpel debridement lessened forefoot pain but the effect was no greater than sham treatment. Localized pressure or gait function was not significantly improved following treatment.     

Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial

BACKGROUND: In a phase II study, etanercept (recombinant human tumor necrosis factor receptor [p75]:Fc fusion protein) safely produced rapid, dose-dependent improvement in rheumatoid arthritis over 3 months. OBJECTIVE: To confirm the benefit of etanercept therapy of longer duration and simplified dosing in patients with rheumatoid arthritis. DESIGN: Randomized, double-blind, placebo-controlled trial with blinded joint assessors. SETTING: 13 North American centers. PATIENTS: 234 patients with active rheumatoid arthritis who had an inadequate response to disease-modifying antirheumatic drugs. INTERVENTION: Twice-weekly subcutaneous injections of etanercept, 10 or 25 mg, or placebo for 6 months. MEASUREMENTS: The primary end points were 20% and 50% improvement in disease activity according to American College of Rheumatology (ACR) responses at 3 and 6 months. Other end points were 70% ACR responses at 3 and 6 months and other measures of disease activity at 3 and 6 months. RESULTS: Etanercept significantly reduced disease activity in a dose-related fashion. At 3 months, 62% of the patients receiving 25 mg of etanercept and 23% of the placebo recipients achieved 20% ACR response (P < 0.001). At 6 months, 59% of the 25-mg group and 11% of the placebo group achieved a 20% ACR response (P < 0.001); 40% and 5%, respectively, achieved a 50% ACR response (P < 0.01). The respective mean percentage reduction in the number of tender and swollen joints at 6 months was 56% and 47% in the 25-mg group and 6% and -7% in the placebo group (P < 0.05). Significantly more etanercept recipients achieved a 70% ACR response, minimal disease status (0 to 5 affected joints), and improved quality of life. Etanercept was well tolerated, with no dose-limiting toxic effects. CONCLUSIONS: Etanercept can safely provide rapid, significant, and sustained benefit in patients with active rheumatoid arthritis.     

Long-term efficacy of a cognitive behavioural treatment from a randomized controlled trial for patients recently diagnosed with rheumatoid arthritis

OBJECTIVES: This study examined the long-term efficacy of a cognitive behavioural intervention for patients with recent-onset, seropositive rheumatoid arthritis (RA). METHODS: Fifty-three consecutive patients with less than a 2-yr history of classic or definite RA were recruited into the trial. All participants received routine medical management during the study, and half were randomly allocated to receive an 8-week adjunctive psychological intervention. All assessments were conducted blind to the allocation. This paper reports intention-to-treat analyses of the 18-month follow-up. RESULTS: Consistent with short-term results, significant differences were found between the groups in depressive symptoms. The intervention group maintained improvements in joint function, although those in routine care made similar improvements over the ensuing 18 months. At follow-up, group differences emerged for disability and anxiety. CONCLUSIONS: These results indicate that cognitive behavioural intervention offered as an adjunct to standard clinical management early in the course of RA is efficacious in producing improvements in both psychological and physical indices. Furthermore, improvements appear to increase 18 months after a brief, time-limited psychological treatment.     

The methotrexate therapeutic response in rheumatoid arthritis

OBJECTIVE: Methotrexate (MTX) is used frequently as a disease modifying antirheumatic drug (DMARD) for rheumatoid arthritis (RA), and patients tend to continue taking this drug for longer periods than alternative single agents. The shape of the therapeutic response beyond one or 2 years, however, has not been fully studied. We examined the properties of the pure MTX "therapeutic segment," that period that begins with start of MTX and terminates when MTX is discontinued or another DMARD is added, by observational study. METHODS: We studied new MTX starts for the period 1988 through 1996 for 437 patients from a parent cohort of 4253 patients. Patients were drawn from 8 Arthritis, Rheumatism, and Aging Medical Information System (ARAMIS) data centers: 2 community based populations; 2 private rheumatological practices; 2 university referral practices; and 2 university clinics for underserved minority urban populations. Health Assessment Questionnaire (HAQ) Disability Index scores (0-3) were obtained prospectively each 6 months. RESULTS: At MTX start, patients had relatively long average disease duration of 16.7 years, and had moderately severe disability, with an initial HAQ mean disability score of 1.48. Over the 10 year period examined in the parent cohort of 4253 patients (and thus irrespective of therapy), the prevalence of MTX use rose from 19% to 45%, while mean HAQ disability declined from 1.34 to 1.11. This correspondence is consistent with an accrual of benefits from more frequent use of MTX and other DMARD over this period. The MTX therapeutic segment revealed a distinct shape. HAQ-Disability Index values began at 1.48 at baseline and declined to a maximal improvement of 1.23 at 30 months. This long period to maximum benefit may have been partly driven by a slow titration upward to an optimal dosage. After 42 months, disability for this population began to re-progress and reached 1.39 at 84 months, still below the pretreatment baseline. Re-progression to baseline was about 8 or more years. Cumulative disability averted with MTX treatment for this population was roughly 1.30 disability-unit-years. CONCLUSION: MTX treatment of RA in practice differs substantially from common perception and appears suboptimal by being too little, too late, and too long to treatment change. A modification of the "sawtooth strategy" in which the disease is "ratcheted down" by change of MTX therapy at 3 years or when re-progression has proceeded halfway to baseline, rather than waiting for return to baseline, is suggested by these data. Also suggested is the need for more rapid upward dosage titration and longer maintenance of an optimal or highest tolerated dosage. "Therapeutic segment" data provide insights into strategic approaches to management of RA since they allow estimation of population aggregate properties such as time to maximum benefit and the time to return to baseline.     

Effect of a collective educational program for patients with rheumatoid arthritis: a prospective 12-month randomized controlled trial

OBJECTIVE: To evaluate the effect on health and functional status of an 8-week group-education program for rheumatoid arthritis (RA) in addition to usual medical care. METHODS: All consecutive inpatients and outpatients with RA (ACR criteria) were asked to participate in this randomized, prospective, controlled trial. The educational intervention consisted of 8 weekly ambulatory sessions, each lasting 6 hours. Followup was undertaken after 1 year. The primary criterion for judging effectiveness was the Health Assessment Questionnaire (HAQ) score; secondary criteria consisted of coping, medical knowledge, patient global satisfaction, and quality of life scores before the intervention and after 1 year. RESULTS: We asked 1242 inpatients and outpatients to participate in the study: 208 (16.75%) agreed (104 in each group). At baseline, there was no statistically significant difference between the 2 groups. After 1 year, no statistically significant difference was observed between the 2 groups in change in HAQ score: -0.04 +/- 0.46 (education group) vs -0.06 +/- 0.47 (control group) (p = 0.79). Statistically significant differences were found in 3 domains: patient coping (-1.22 +/- 5.55 vs -0.22 +/- 3.81; p = 0.03), knowledge (3.42 +/- 4.73 vs 0.73 +/- 3.78; p < 0.0001), and satisfaction (10.07 +/- 11.70 vs 5.72 +/- 13.77; p = 0.02), all of which were better for the group attending the education sessions. CONCLUSION: Despite improvements in patient coping, knowledge, and satisfaction, the education program was not found to be effective at 1 year. There may have been methodological problems relating to the sensitivity of questionnaires and patient selection, and tailored educational interventions should be considered.     

A randomized controlled trial to evaluate the effectiveness of homeopathy in rheumatoid arthritis

Forty-four patients with active Rheumatoid Arthritis were entered into a 6-month double-blind trial comparing homeopathy and placebo. The treatments were generally equally effective in most assessments. Statistically significant improvements were produced, however, in 3 of 5 and 2 of 5 results respectively assessed in homeopathic and placebo treated groups. There was no statistically significant difference between groups. Adverse effects were scarcely and comparably reported in both groups and did not require a change in therapy.     

Assessment of the effectiveness of low-level laser therapy on the hands of patients with rheumatoid arthritis: a randomized double-blind controlled trial

Assess the effectiveness of low-level laser therapy on pain reduction and improvement in function in the hands of patients with rheumatoid arthritis. A randomized double-blind controlled trial was carried out on 82 patients with rheumatoid arthritis. The experimental group was submitted to the application of laser therapy, whereas the control group received a placebo laser. Aluminum gallium arsenide laser was used, at a wavelength of 785 nm, dose of 3 J/cm² and mean power of 70 mW. The groups were homogenous at the beginning of the study with regard to the main variables (p > 0.05). There were no statistically significant differences between groups in most of the measurements taken at the end of the intervention including the primary variables; the following variables were the exceptions: favoring the experimental group—inflammation of the interphalangeal joint of the right thumb (p = 0.012) and perimetry of the interphalangeal joint of the left thumb (p = 0.013); and favoring the control group—flexion of the proximal interphalangeal joint of the right fifth finger (p = 0.021), perimetry of the third proximal interphalangeal joint of the right hand (p = 0.044), grip strength in the left hand (p = 0.010), and the work domain of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire (p = 0.010). We conclude that low-level aluminum gallium arsenide laser therapy is not effective at the wavelength, dosage, and power studied for the treatment of hands among patients with rheumatoid arthritis.     

A theory-based intervention to promote medication adherence in patients with rheumatoid arthritis: A randomized controlled trial

Clinical Rheumatology - Adherence to prescribed medication regimens is fundamental to the improvement and maintenance of the health of patients with rheumatoid arthritis. It is therefore important...     

Correction to: Patient-controlled outpatient follow-up on demand for patients with rheumatoid arthritis: a 2-year randomized controlled trial

Clinical Rheumatology -