Physiotherapy-based rehabilitation following disc herniation operation: results of a randomized clinical trial.

STUDY DESIGN: Three-group, randomized, single blinded, controlled trial. OBJECTIVE: To test the effectiveness of physiotherapy-based rehabilitation starting 1 week after lumbar disc surgery. In addition, we tried to estimate the contribution of specific effects to the observed outcome (efficacy). SUMMARY OF BACKGROUND DATA: Physiotherapy-based rehabilitation is usually recommended for patients following lumbar disc surgery. Few and conflicting data exist for the relative effectiveness of this intervention. METHODS: A total of 120 patients following first-time, uncomplicated lumbar disc surgery were randomly assigned to "comprehensive" physiotherapy, "sham" neck massage, or no therapy. Before enrollment, all subjects completed a minimal physiotherapeutic intervention. Physiotherapy was administered by experienced physiotherapists and consisted of 20 sessions per patient over 12 weeks. Masseurs administered "sham massage" to the neck. The amount of treatment time was equal to that of physiotherapy. The main outcome measure was the Low Back Pain Rating Score (LBPRS) at 6 and 12 weeks, and 1.5 years after randomization. Secondary parameters were patients' overall satisfaction with treatment outcome and socioeconomic and psychologic measures. RESULTS: At the end of therapy (12 weeks), the LBPRS revealed a significantly better improvement in the physiotherapy group than in the untreated group. LBPRS outcome, however, did not significantly differ between physiotherapy and "sham" therapy. There was a tendency toward significance between the sham therapy and no therapy. Within the 1.5-year follow-up, LBP rating scales remained significantly improved compared with baseline, but there were no significant outcome differences. No statistically significant between-group differences were found for the secondary outcome parameters. CONCLUSION: As compared with no therapy, physiotherapy following first-time disc herniation operation is effective in the short-term. Because of the limited benefits of physiotherapy relative to "sham" therapy, it is open to question whether this treatment acts primarily physiologically in patients following first-time lumbar disc surgery, but psychological factors may contribute substantially to the benefits observed.

Prospective, randomized, multicenter, double-blind placebo-controlled trial comparing adjuvant interferon alfa and isotretinoin with interferon alfa alone in stage IIA and IIB melanoma: European Cooperative Adjuvant Melanoma Treatment Study Group.

PURPOSE: The combination of interferon alfa (IFNalpha) and isotretinoin has shown a direct antiproliferative effect on human melanoma cell lines, but it remained unclear whether this combination is more effective than IFNalpha alone in patients with metastatic melanoma. We evaluated safety and efficacy of IFNalpha and isotretinoin compared with IFNalpha alone as adjuvant treatment in patients with primary malignant melanoma stage IIA and IIB. PATIENTS AND METHODS: In a prospective, randomized, double-blind, placebo-controlled trial, 407 melanoma patients in stage IIA (301 patients) and IIB (106 patients) were randomly assigned to either IFNalpha and isotretinoin (isotretinoin group; 206 patients) or IFNalpha and placebo (placebo group; 201 patients) after excision of the primary tumor. IFNalpha was administered three times a week at a dose of 3 million units subcutaneously for 24 months. Isotretinoin at a dose of 20 mg for patients < or = 73 kg, 30 mg for patients greater than 73 kg, or placebo daily for 24 months. RESULTS: A scheduled interim analysis revealed no significant differences in survival rates, with the isotretinoin group and the placebo group showing 5-year disease-free survival rates of 55% (95% CI, 46% to 65%) and 67% (95% CI, 59% to 75%), respectively, and overall 5-year survival rates of 76% (95% CI, 67% to 84%) and 81% (95% CI, 74% to 88%), respectively. The trial was stopped for futility. CONCLUSION: The addition of isotretinoin to an adjuvant treatment of low-dose IFNalpha in patients with stage IIA and IIB melanoma had no significant effect on disease-free or overall survival and is therefore not recommended.

[Optimizing electrotherapy--a comparative study of 3 different currents]. / Optimierung der Schwellstrombehandlung--eine Vergleichsstudie von drei unterschiedlichen Stromformen.

Neuromuscular electrical stimulation can be used to increase strength of skeletal muscle. In neuromuscular electrical stimulation of innervated skeletal muscle, the application of the highest possible intensities of electricity is an important determinant of therapeutic success with regard to strength training. The therapeutic goal of "strengthening muscles" is opposed to the side effect of discomfort through the application of electricity. The aim of the present study was to compare three forms of electric current with respect to subjective tolerance and maximum achievable muscular strength. Twenty-nine healthy male volunteers were included in a single-blind study in which three forms of electric current were applied in a randomized fashion. The following types were compared: a short monophasic form, a biphasic form that was twice as long in terms of impulse duration, and a long monophasic form with an equal impulse duration than tht of the biphasic form and with an impulse form that corresponded to the short monophasic current. Stimulation was administered via surface electrodes placed on the knee extensors in the lower extremity on the right side. The intensity of the current was increased to the individual limit of tolerance or to a maximum of 100 mA. The main target parameter used to determine the success of treatment was the maximum electrically induced strength as a percentage of maximal voluntary contraction. The short monophasic form of electricity was associated with much less discomfort than the long monophasic and biphasic forms (p < 0.0001, p = 0.0062). Furthermore, the biphasic form was better tolerated (and therefore had a larger therapeutic range of application) than the long monophasic form (p = 0.041). The biphasic and long monophasic forms produced higher values for maximum electrically induced strength than did the short monophasic form (p = 0.0001, p = 0.0010). To summarize: the biphasic form had a larger range of therapeutic application than the long monophasic form. Furthermore, the biphasic form produced 40% more electrically induced strength than the short monophasic one. It may be concluded that, in terms of therapeutic application, the biphasic form of electric current is superior to the monophasic forms described in the present study.