Rheumatology international
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Randomized Controlled Trial
Body mass index and response to a multidisciplinary treatment of fibromyalgia.
The purpose of this study is to determine whether there are some differences in the treatment responses to a multidisciplinary fibromyalgia (FM) treatment related with the baseline body mass index (BMI) of the participants. Inclusion criteria consisted of female sex, a diagnosis of FM (American College of Rheumatology criteria), age between 18 and 60 years, and between 3 and 8 years of schooling. Baseline BMI was determined, and patients were randomly assigned to one of the two treatment conditions: conventional pharmacologic treatment or multidisciplinary treatment. ⋯ General linear model analysis showed a significant interaction group treatment × time in pain intensity (p < .01), functionality (p < .0001), catastrophizing (p < .01), psychological distress (p < .0001), sleep index problems (p < .0001), and health-related quality of life (p < .05). No significant interactions were found in BMI × time, and in BMI × group treatment × time. There are not differences among normal weight, overweight and obese patients with FM regarding their response to a multidisciplinary treatment programme for FM which combines pharmacological treatment, education, physical therapy and cognitive behavioural therapy.
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Randomized Controlled Trial Comparative Study
Assessment of the effectiveness of interferential current therapy and TENS in the management of carpal tunnel syndrome: a randomized controlled study.
We assessed the effectiveness of interferential current (IFC) and transcutaneous electrical nerve stimulation (TENS) therapies in the management of carpal tunnel syndrome (CTS) compared with splint therapy, a standard treatment modality for CTS. This was a prospective, single-blinded, single-center, randomized, three-group parallel intervention study of 3 weeks duration. Efficacy was examined in the third week after the end of treatments. ⋯ There was no statistically significant difference between TENS and splint therapy with respect to improvement in clinical scores, whereas IFC therapy provided a significantly greater improvement in VAS, mMDL, and mSNCV values than splint therapy (VAS: 4.80 ± 1.18 and 6.37 ± 1.18; p = 0.001, mMDL: 3.89 ± 0.88 and 4.06 ± 0.61; p = 0.001, mSNCV: 41.80 ± 1.76 and 40.75 ± 1.48; p = 0.010). IFC therapy provided a significantly greater improvement in VAS, symptom severity, functional capacity, and mMDL and mSNCV values than TENS therapy (VAS: 4.80 ± 1.18 and 6.68 ± 1.42; p < 0.001, symptom severity: 2.70 ± 1.03 and 3.37 ± 1.21; p = 0.015, functional capacity: 1.90 ± 1.21 and 2.50 ± 0.78; p = 0.039, mMDL: 3.89 ± 0.88 and 4.06 ± 0.88; p = 0.003, and mSNCV: 41.80 ± 1.76 and 41.38 ± 1.78; p = 0.021). IFC may be considered a new and safe therapeutic option for the treatment of CTS.
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Randomized Controlled Trial Multicenter Study
A randomized, double-blind, and placebo-controlled multicenter clinical trial of a novel cytotoxic T-lymphocyte antigen-4 fusion protein, Leining, in Chinese active rheumatoid arthritis patients with an inadequate response to methotrexate.
To assess the clinical efficacy as well as safety profiles of Leining, a novel cytotoxic T-lymphocyte antigen-4 fusion protein, versus placebo in the treatment of Chinese active rheumatoid arthritis (RA) patients with an inadequate clinical response to methotrexate (MTX). In this 24-week, randomized, double-blind, placebo-controlled multicenter study, a total of 440 Chinese patients with active RA with an inadequate response to MTX were randomly assigned to receive Leining (10 mg/kg) or placebo. Clinical response was assessed using the American College of Rheumatology 20 % improvement criteria ACR20, ACR50, and ACR70, with ACR20 as the primary major endpoints. ⋯ No neutralizing antibodies were detected. Leining demonstrated clinically meaningful efficacy compared with placebo in Chinese patients with active RA despite MTX therapy. Administration of Leining in combination with MTX for 24 weeks was well tolerated.
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Randomized Controlled Trial Multicenter Study Comparative Study
Efficacy and safety of PG201 (Layla(®)) and celecoxib in the treatment of symptomatic knee osteoarthritis: a double-blinded, randomized, multi-center, active drug comparative, parallel-group, non-inferiority, phase III study.
The objectives of the study are to demonstrate the non-inferiority of PG201 (Layla(®)) 600 mg in comparison with celecoxib 200 mg for the treatment of symptomatic knee osteoarthritis (OA). In total, 309 patients were randomly assigned to receive either the test drug, PG201 600 mg (n = 154) or celecoxib 200 mg (n = 155). The primary efficacy variable was improvement in mean 100-mm pain VAS score from baseline to the final visit (week 8), and this value was compared between the 2 treatment groups. ⋯ These results met pre-specified criteria for non-inferiority for both the intent-to-treat and per-protocol populations. PG201 600 mg and celecoxib 200 mg were both well tolerated and no statistically significant differences in the tolerability profile between the groups. PG201 600 mg was as effective and safe as celecoxib 200 mg in the treatment of symptomatic knee OA and might be a useful new medication for the treatment of symptomatic knee OA.
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Randomized Controlled Trial Comparative Study
Comparison of the therapeutic effects of intramuscular subscapularis and scapulothoracic bursa injections in patients with scapular pain: a randomized controlled trial.
Scapulothoracic bursitis contributes to considerable morbidity in some patients with scapular pain. A scapulothoracic bursa injection can induce symptomatic relief; however, blind injections into the scapulothoracic bursa may involve injecting into the subscapularis muscle itself. The aim of this study was to compare the therapeutic effects of intramuscular injections into the subscapularis under ultrasound (US) guidance with those of blind scapulothoracic bursa injections in patients with scapular pain. ⋯ However, no significant difference was observed between intramuscular injection into the subscapularis and the scapulothoracic bursa injection. No serious complications were encountered. In conclusion, injections at the scapulothoracic bursa without US guidance did not exclude the possibility of an effect of steroid on the subscapularis muscle, as both intramuscular injections into the subscapularis and scapulothoracic bursa injections in patients with scapular pain provided equal symptomatic relief, and all patients developed tenderness in their subscapularis muscle.