The aim of the study is to evaluate the efficacy of a wearable device using pulse electromagnetic fields on pain intensity reduction, measured by visual analogue score (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), in patients affected by osteoarthritis Secondary aim is the evaluate the effect on knee effusion reduction, when present and to evaluate pain intensity changes corrected by pain threshold measured by pressure algometry.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
66
Reumatologia, Dipartimento di medicina clinica e sperimentale, Università degli studi di Messina, AOU G. Martino
Messina, Messina, Italy
Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4
visual analogue scale (VAS) is a validated self report instrument assessing self report pain intensity Possible scores ranges:from 0 (no pain) to 100 (the maximum of pain)
Time frame: baseline and 4 weeks
Changes From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 4
Multi-item questionnaire used to assess pain, stiffness, and physical function in patients with knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items) and Physical Function (17 items). Score Range: On the Likert Scale version, the scores are summed for items in each subscale, with possible ranges as follows: pain=0-50, stiffness=0-20, physical function=0-170. A total WOMAC score is created by summing the items for all three subscales. A higher score represents a worse outcome.
Time frame: baseline and 4 weeks
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