Low-level laser therapy on hands of patients with rheumatoid arthritis

Clinical Rheumatology -     

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.     

Additive effects of low-level laser therapy with exercise on subacromial syndrome: a randomised,double-blind,controlled trial

The subacromial syndrome is the most common source of shoulder pain. The mainstays of conservative treatment are non-steroidal anti-inflammatory drugs and exercise therapy. Recently, low-level laser therapy (LLLT) has been popularized in the treatment of various musculoskeletal disorders. The aim of this study is to evaluate the additive effects of LLLT with exercise in comparison with exercise therapy alone in treatment of the subacromial syndrome. We conducted a randomised clinical study of 80 patients who presented to clinic with subacromial syndrome (rotator cuff and biceps tendinitis). Patients were randomly allocated into two groups. In group I (n = 40), patients were given laser treatment (pulsed infrared laser) and exercise therapy for ten sessions during a period of 2 weeks. In group II (n = 40), placebo laser and the same exercise therapy were given for the same period. Patients were evaluated for the pain with visual analogue scale (VAS) and shoulder range of motion (ROM) in an active and passive movement of flexion, abduction and external rotation before and after treatment. In both groups, significant post-treatment improvements were achieved in all parameters (P = 0.00). In comparison between the two groups, a significant improvement was noted in all movements in group I (P = 0.00). Also, there was a substantial difference between the groups in VAS scores (P = 0.00) which showed significant pain reduction in group I. This study indicates that LLLT combined exercise is more effective than exercise therapy alone in relieving pain and in improving the shoulder ROM in patients with subacromial syndrome.     

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.     

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.     

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...     

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...     

The effects of intravenous doxycycline therapy for rheumatoid arthritis: a randomized, double-blind, placebo-controlled trial

OBJECTIVE: To determine the feasibility, safety, and potential clinical efficacy of intravenous (IV) doxycycline therapy for rheumatoid arthritis (RA), as well as its possible effects on serum and urinary markers of collagen breakdown. METHODS: The exploratory trial was designed as a 16-week, single-center, randomized, double-blind, placebo-controlled trial. Eligible subjects with active seropositive or erosive RA were randomly allocated into 3 treatment groups: doxycycline 200 mg IV, azithromycin 250 mg orally, or placebo. The blinded IV study drug was administered once daily for the first 3 weeks by home self-infusion and then weekly for the next 8 weeks, concurrent with the blinded oral study drug at the prescribed doses. The primary end points were the change between baseline and week 4 in the tender joint count, erythrocyte sedimentation rate, and urinary excretion of pyridinoline. RESULTS: The trial was stopped prematurely after enrollment of 31 patients. Three subjects were withdrawn because of worsening arthritis, and 1 patient was withdrawn when newly diagnosed with breast cancer. Infusion-related events occurred in 13 (42%) of 31 patients, but none were serious. There were 4 serious adverse events unrelated to the study drug, including a new diagnosis of breast cancer in 3 cases and hospitalization for abdominal pain in 1 case. No significant differences were observed across treatment groups in any of the 3 primary clinical end points. CONCLUSION: Although IV doxycycline therapy was generally well-tolerated by patients in this trial, it did not show any evidence of reducing disease activity or collagen crosslink production.     

Low-dose D-penicillamine therapy in rheumatoid arthritis. A controlled, double-blind clinical trial

Two hundred twenty-five patients with active severe rheumatoid arthritis were admitted to a multiclinic, controlled, double-blind trial comparing the use of 500 mg D-penicillamine per day, 125 mg D-penicillamine per day, and placebo. One hundred seventy-one patients completed at least 30 weeks of therapy. The 500 mg D-penicillamine group demonstrated statistically significant improvement over the placebo group in grip strength, average circumference of swollen proximal interphalangeal joints, and patient assessment. While the trend was for greater improvement with the larger dose of D-penicillamine, there was no statistically significant difference among the 3 groups in duration of morning stiffness, walking time, physician's assessment, number of swollen joints, or scores for tender and swollen joints. The slight increase in efficacy of higher dose D-penicillamine was associated with increased toxicity.     

Efficacy of methotrexate treatment in patients with probable rheumatoid arthritis: a double-blind, randomized, placebo-controlled trial

OBJECTIVE: To determine whether patients with undifferentiated arthritis (UA; inflammatory, nontraumatic arthritis that cannot be diagnosed using current classification criteria) benefit from treatment with methotrexate (MTX). METHODS: The PRObable rheumatoid arthritis: Methotrexate versus Placebo Treatment (PROMPT) study was a double-blind, placebo-controlled, randomized, multicenter trial involving 110 patients with UA who fulfilled the American College of Rheumatology (ACR) 1958 criteria for probable RA. Treatment started with MTX (15 mg/week) or placebo tablets, and every 3 months the dosage was increased if the Disease Activity Score was >2.4. After 12 months, the study medication was tapered and discontinued. Patients were followed up for 30 months. When a patient fulfilled the ACR criteria for RA (primary end point), the study medication was changed to MTX. Joint damage was scored on radiographs of the hands and feet. RESULTS: In 22 of the 55 patients (40%) in the MTX group, UA progressed to RA compared with 29 of 55 patients (53%) in the placebo group. However, in the MTX group, patients fulfilled the ACR criteria for RA at a later time point than in the placebo group (P = 0.04), and fewer patients showed radiographic progression over 18 months (P = 0.046). CONCLUSION: This study provides evidence for the efficacy of MTX treatment in postponing the diagnosis of RA, as defined by the ACR 1987 criteria, and retarding radiographic joint damage in UA patients.     

Concomitant iguratimod therapy in patients with active rheumatoid arthritis despite stable doses of methotrexate: a randomized, double-blind, placebo-controlled trial

Objectives

To investigate the efficacy and safety of iguratimod (T-614) in Japanese patients with active rheumatoid arthritis who had inadequate response to stable background methotrexate (MTX) alone.

Methods

In this multicenter, double-blind, controlled trial, a total of 253 patients were randomized at 2:1 ratio to either the iguratimod group or the placebo group. Iguratimod was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for the subsequent 20 weeks (25 mg twice daily). MTX at dosage of 6 or 8 mg/week was administered to patients in both groups.

Results

The rate of 20 % improvement in American College of Rheumatology criteria (ACR20) at week 24 was 69.5 % in the iguratimod group compared with 30.7 % in the placebo group (P < 0.001). Significant improvements in the ACR50, ACR70, Health Assessment Questionnaire Disability Index, Disease Activity Score 28 <3.2, and rheumatoid factor were also observed. The most commonly reported adverse events (AEs) were blood iron decrease, nasopharyngitis, and lymphocyte decrease. These AEs were mild or moderate in severity. No deaths occurred.

Conclusion

The study results suggest that iguratimod in combination with MTX was efficacious and had a manageable safety profile.     

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.     

Treatment of rheumatoid arthritis with L-histidine: a randomized, placebo-controlled, double-blind trial.

A randomized cooperative double-blind trial of oral L-histidine for the treatment of rheumatoid arthritis was carried out. Patients were treated with either L-histidine 4.5 g daily, or placebo, for 30 weeks. None of the clinical measurements showed an advantage of histidine over placebo. A small decrease in rheumatoid factor titer and a small increase in hematocrit were found only in the histidine group. There was suggestive evidence of a beneficial effect of histidine in patients with more active and prolonged disease, based upon subjective doubld-blind evaluations by physicians and patients. No adverse effects of histidine therapy were noted. Histidine cannot be advocated as a therapeutic agent in rheumatoid arthritis, but further studies in certain groups of patients seem justified.     

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...     

Assessment of radiologic progression in rheumatoid arthritis. A randomized, controlled trial

Radiologic assessment of progressive joint destruction in rheumatoid arthritis is generally considered to be the ultimate standard for evaluation of treatment. We compared alternative radiologic techniques by performing a randomized, controlled trial in which hand films of rheumatoid arthritis patients were read by several skilled observes. The number of joints evaluated (34 versus 18) was found to make relatively little difference, but the number of readers and their experience level was critical. Films should be read in pairs. Joint space narrowing and erosion scores were shown to contribute independent information. Use of recommended techniques can reduce the number of patients required and, thus, can reduce the cost of a clinical trial by more than half and can substantially increase the sensitivity and efficiency of a trial. Therefore, critical selection of the method of assessing study endpoint is of great importance.     

Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial

OBJECTIVE: To compare the benefits of initiating treatment with methotrexate (MTX) and infliximab (anti-tumor necrosis factor alpha [anti-TNFalpha] monoclonal antibody) with those of MTX treatment alone in patients with rheumatoid arthritis (RA) of < or =3 years' duration. METHODS: RA patients were eligible if they had active disease and no prior treatment with MTX or a TNFalpha inhibitor. One thousand forty-nine patients were randomly assigned in a 4:5:5 ratio to 3 treatment groups: MTX-placebo, MTX-3 mg/kg infliximab, and MTX-6 mg/kg infliximab. MTX dosages were rapidly escalated to 20 mg/week, and infliximab or placebo infusions were given at weeks 0, 2, and 6, and every 8 weeks thereafter through week 46. RESULTS: At week 54, the median percentage of American College of Rheumatology improvement (ACR-N) was higher for the MTX-3 mg/kg infliximab and MTX-6 mg/kg infliximab groups than for the MTX-placebo group (38.9% and 46.7% versus 26.4%, respectively; P < 0.001 for both comparisons). Patients in the MTX-3 mg/kg infliximab and MTX-6 mg/kg infliximab groups also showed less radiographic progression than those receiving MTX alone (mean +/- SD changes in van der Heijde modification of the total Sharp score at week 54: 0.4 +/- 5.8 and 0.5 +/- 5.6 versus 3.7 +/- 9.6, respectively; P < 0.001 for each comparison). In addition, physical function improved significantly more in the MTX-3 mg/kg infliximab and MTX-6 mg/kg infliximab groups than in the MTX-placebo group. Infliximab therapy was associated with a significantly higher incidence of serious infections, especially pneumonia. CONCLUSION: For patients with active RA in its early stages, combination therapy with MTX and infliximab provides greater clinical, radiographic, and functional benefits than treatment with MTX alone.     

Mud compress therapy for the hands of patients with rheumatoid arthritis

Objective The aim of this study was to evaluate the efficacy of home treatment with mud compresses for the hands of patients with rheumatoid arthritis (RA).Methods Forty-five patients suffering from RA were enrolled in a double-blind, randomized, controlled study. Twenty-two were treated with true mud compresses (treatment group) and 23 were treated with attenuated mud compresses (control group). The compresses were applied in the patients homes five times a week during a 3-week period. Patients were assessed four times: at baseline, upon completion of the 3-week treatment period, 1 month after the treatment, and 3 months after conclusion of the treatment period. Positive response was defined as reductions of 30% or more in the number of tender and swollen joints, 20% or more in physician global assessment of disease activity, and 20% or more in patient global assessment of the severity of joint pain.Results In the treatment group, significant reductions in the number of swollen and tender joints and patients global assessments of pain severity was observed at all post-treatment assessments. Significant improvement in the scores of physician global assessment was seen at the end of therapy and 1 month later. In the control group, no improvement in the number of swollen and tender joints or physician global assessment was found in any post-treatment evaluation. However, a significant reduction in patient global assessment of joint pain severity was reported at the end of therapy and 3 months after concluding treatment.Conclusion Treatment with mud compresses relieves pain affecting the hands and reduces the number of swollen and tender joints in the hands of patients suffering from RA. This treatment can augment conventional medical therapy in these patients.