Effectiveness and safety of a mixture of diosmin, coumarin and arbutin (Linfadren®) in addition to conventional treatment in the management of patients with post-trauma/surgery persistent hand edema: a randomized controlled trial.

OBJECTIVE: To evaluate the effectiveness and safety of oral administration of Linfadren® in addition to conventional treatment in patients with post-trauma/surgery persistent hand edema. DESIGN: Parallel-group randomized controlled trial. SETTING: Outpatient rehabilitation center. SUBJECTS: A total of 60 outpatients (mean age 48.5 (standard deviation (SD) = 12.3) years) with post-trauma/surgery persistent hand edema. INTERVENTIONS: Patients were randomized to either receive six-week conventional treatment plus Linfadren® (Study Group) or conventional treatment (Control Group). MAIN MEASURES: Primary outcome was hand edema as measured by figure-of-eight method. Secondary outcomes were hand function, patient's overall perceived treatment effectiveness and rescue medication request. Tolerability of Linfadren® was also evaluated. Assessments were performed at baseline, at the end of treatment and three months after the end of treatment. RESULTS: All patients completed the six-week program and 57 patients (95%) completed the three-month follow-up. At six weeks, the Study Group had significantly greater improvement in hand edema (423.3 (SD = 23.8) mm vs 439.4 (SD = 22.6) mm; P = 0.009) and upper limb function ( Quick Disabilities of Arm, Shoulder and Hand questionnaire: 23.6 (SD = 13.6) vs 37.7 (SD = 15.9); P = 0.005) compared to the Control Group. Moreover, the percentage of patients who perceived treatment as effective was significantly higher in the Study Group than in the Control Group both after treatment (70% vs 37%, P = 0.002) and at follow-up (77% vs 30%, P < 0.0001). The rescue medication request was not different between groups. No adverse events were recorded. CONCLUSION: Linfadren® in addition to conventional treatment was safe and more effective than conventional treatment alone in patients with post-trauma/surgery persistent hand edema.

The Italian version of the lower extremity functional scale was reliable, valid, and responsive.

OBJECTIVE: To determine the measurement properties of an Italian Version of the Lower Extremity Functional Scale (LEFS) in patients with lower extremity musculoskeletal dysfunction. STUDY DESIGN AND SETTING: This is a prospective methodological study of repeated measures with a sample of 250 consecutive patients. Reliability, validity, and responsiveness were evaluated. RESULTS: The Italian version of the LEFS showed a high degree of internal consistency with a Cronbach alpha of 0.94 (95% confidence interval [CI]: 0.91, 0.96). The test-retest reliability was high for both intra-interviewer and inter-interviewer measures with an ICC((2,1 and 2,k)) of 0.91 (95% CI: 0.86, 0.93) and 0.89 (95% CI: 0.83, 0.91), respectively. The LEFS showed a better correlation with the 36-Item Short-Form Health Survey (SF-36) physical component summary score rather than with the SF-36 mental component summary score both at the initial assessment (r=0.61 and 0.26, respectively) and at the discharge (r=0.72 and 0.22, respectively). Receiver operating characteristic curve analysis revealed a large responsiveness for the LEFS (area under the curve [AUC]=0.97) and a moderate responsiveness for the SF-36 (AUC=0.68). CONCLUSION: The Italian version of the LEFS is a valid, reliable, and responsive tool that can be used to measure function in Italian patients with lower extremity musculoskeletal dysfunction.

Mirror therapy in complex regional pain syndrome type 1 of the upper limb in stroke patients.

BACKGROUND: Complex regional pain syndrome type 1 (CRPSt1) of the upper limb is a painful and debilitating condition, frequent after stroke, and interferes with the rehabilitative process and outcome. However, treatments used for CRPSt1 of the upper limb are limited. OBJECTIVE: . This randomized controlled study was conducted to compare the effectiveness on pain and upper limb function of mirror therapy on CRPSt1 of upper limb in patients with acute stroke. METHODS: . Of 208 patients with first episode of unilateral stroke admitted to the authors' rehabilitation center, 48 patients with CRPSt1 of the affected upper limb were enrolled in a randomized controlled study, with a 6-month follow-up, and assigned to either a mirror therapy group or placebo control group. The primary end points were a reduction in the visual analogue scale score of pain at rest, on movement, and brush-induced tactile allodynia. The secondary end points were improvement in motor function as assessed by the Wolf Motor Function Test and Motor Activity Log. RESULTS: . The mean scores of both the primary and secondary end points significantly improved in the mirror group (P < .001). No statistically significant improvement was observed in any of the control group values (P > .001). Moreover, statistically significant differences after treatment (P < .001) and at the 6-month follow-up were found between the 2 groups. CONCLUSIONS: . The results indicate that mirror therapy effectively reduces pain and enhances upper limb motor function in stroke patients with upper limb CRPSt1.

Effectiveness of treatment of calcific tendinitis of the shoulder by disodium EDTA.

OBJECTIVE: To evaluate the effectiveness of disodium EDTA administration in the treatment of calcific tendinitis of the shoulder. METHODS: Eighty patients with radiographically verified calcific tendinitis of the shoulder were enrolled between September 2001 and October 2003. Patients were randomly assigned to either a study group (n = 40) or a control group (n = 40). Pain and functional level were evaluated before and after treatment and at 1-year followup. Radiographic modifications in calcifications were evaluated before and after treatment. Disodium EDTA was administered through single needle mesotherapy and 15 minutes of pulsed-mode 1 MHz-ultrasound. RESULTS: The study group displayed improvement in all of the parameters analyzed after treatment and at the 1-year followup. Calcifications disappeared completely in 62.5% of the patients in the study group and partially in 22.5%; calcifications partially disappeared in only 15% of the patients in the control group, and none displayed a complete disappearance. CONCLUSION: Our results suggest that the use of disodium EDTA for the management of calcific tendinitis of the shoulder is safe and effective, leading to a significant reduction in pain, improvement in shoulder function, and disappearance of calcifications after 4 weeks, without adverse effects.