Intervenção ortopodológica em pacientes com neuropatia periférica e diabetes tipo 2. Repercussão na qualidade de vida e no nível funcional

Résumé

Background Diabetes Mellitus (DM) is currently a chronic disease that reaches huge proportions. Chronic hyperglycemia can lead to the development of a set of long-term complications, including peripheral diabetic polyneuropathy (DPN). Because of the loss of protective sensation, feet are vulnerable to minor trauma caused by plantar pressure (PP) as well as mechanical and thermal injuries. Thus, Plantar Orthoses (PO) become necessary to reduce PP and align the foot. It is known that footwear is the most frequent cause of diabetic foot injury, since ulceration is frequently a consequence of the continuous trauma provoked by inadequate footwear. For a higher efficacy in the treatment of the foot, it is also necessary to use custom-made orthopedic footwear (OF), indicated in the treatment of foot pathologies. There is evidence that diabetes type 2 is related to poorer quality of life (QoL) perception, especially when there are already associated complications. This disease has also been linked to a worse functional level (FL) due to increased disability and greater difficulty in performing daily life activities. This study is divided into two phases: 1) Translation, Transcultural Adaptation and Validation of the Michigan Neuropathy Screening Instrument (MNSI) for the Portuguese population; 2) Randomized Clinical Trial (RCT). Aims 1) Translation, adaptation and validation of the MNSI. 2) Determine the effectiveness of PO and custom-made OF in FL and QoL. Determine adherence and satisfaction of the applied intervention. Methods 1) An assessment of 30 patients aged 55 – 83 years. The guidelines used for the translation process of the MNSI were based on standards used by the American Association of Orthopedic Surgeons and the reliability analysis was evaluated through internal consistency (Cronbach Alpha (α)), temporal stability (Intra Class Correlation – ICC) and intra- and interobserver agreement (kappa (k) statistics). 2) RCT includes 2 parallel intervention groups in and pre- and post-test analysis. In the SF group, PO and education about self-care of feet and appropriate standard footwear (SF) were applied and in the OF group the same intervention was applied, but with OF. A total of 43 individuals with diabetes type 2 and DPN aged 61 – 76 years were randomized: 20 were assigned to the SF group and 23 to the OF group. The screening of DPN was made with the MNSI and the description of the sample with an evaluation questionnaire. The FL was evaluated through the Lower Extremity Functional Scale (LEFS), physical tests (FRT – Functional Reach Test; UST – Unipedal Stance Test; TST – Tandem Stance Test; TWT – Tandem Walk Test; TUGT – Time Up and Go Test; 6–MWT – Six Minutes Walk Test) and the postural, static and dynamic barometric assessment. QoL was assessed with SF–36 and the adherence and satisfaction with a questionnaire created ad hoc. Results 1) MNSI–Physical Examination: ICC=0.96, 0.94; k ranged 0.42 – 1; α=0.97, 0.98. MNSI – Questionnaire: k ranged 0.35 – 1 and α=0.762, 0.714. 2) There were no differences in QoL between the groups. Both groups improved the physical function (PF) dimension and the emotional performance (EP) and mental summary measure (MSM) of individuals within the OF group decreased, but without significance. There was no statistical evidence that the PO and OF allowed functional improvements compared to the basic treatment. Both groups showed significant improvements in FL (UST barefoot, TST, TUGT and 6–MWT). There were no differences in QoL between groups when assessing the level of activity and adherence to the intervention, but in FL the SF group exhibited better mobility (p=0.049; 0.029) and unipedal balance (p=0.029) and the OF group better functional reach (p=0.042; 0.035). In the postural, static and dynamic barometric assessment, there were also some significant improvements. In the OF group there was only a lower mediolateral (ML) displacement range (DR); greater static surface (S) barefoot in Right Foot (RF) and Left Foot (LF) and with PO in RF; higher dynamic S forefoot (hallux and toes) in barefoot and OF condition; lower toe-out angle in barefoot and OF conditions and greater length (L) of plantar impression (PI) and center of pressure (COP) with OF (p£0.05). Conclusions 1) The Portuguese version – MNSI is a valid assessment instrument of DPN in this sample that can be applied for an early screening. 2) The OF does not show statistical evidence on functional and QoL improvement. Thus, although OF is effective in reducing PP, by decreasing the rate of ulceration recurrence, the low-risk patients using OF do not have significant FL and QoL improvements. The PO showed clinical value, since the evidence indicates that the intervention element that allowed functional gains was the PO.