Foot Orthoses
Four randomised studies evaluating the effects of foot orthoses on pain and functionality in RA patients were identified, including three parallel-group trials that utilised control orthotic devices (traditional or usual-care orthoses)[23,24,26] and one crossover study[25] ( Table 3 ). One of the parallel-group studies[26] incorporated a 2-phase design, in which the initial 2-month randomised, controlled, parallel-group trial was followed by a non-randomised, repeated-measures analysis during which control subjects were supplied with orthotic footwear and re-assessed after 2 months.
Efficacy outcomes were pain, assessed using VAS scores, and functionality, which was assessed via patient-reported HRQL assessment tools.[23-26] These included the Foot Function Index (FFI), a validated questionnaire incorporating a VAS in which patients rate 23 items in three domains (foot pain, disability and functional limitation), the Foot Health Status Questionnaire (FHSA), a validated questionnaire comprising two sections (one with four domains [foot pain, foot function, footwear and general foot health] and one incorporating SF-36 questions on social capacity, general health and vigour), and the Stanford Health Assessment Questionnaire (HAQ), which consists of 20 questions in 8 categories on various tasks of daily living rated on a 4-point scale (0 = without any difficulty; 3 = unable to do).[23-26]
Additionally, the effects of foot orthoses on gait and plantar pressures were assessed in two small randomised trials, including one of the above-mentioned randomised studies (n = 30)[26] and a single-use study of palliative orthoses (n = 16).[27]
Physical function and pain were significantly improved with the use of specialised foot orthoses ( Table 3 ).[23-26] The non-randomised repeated-measures analysis supported the results of the randomised, controlled phase of this study, demonstrated significant improvements in physical function, walk pain, stair pain, and pain-free walk time.[26] Significantly lower mean VAS scores for pain were also reported by patients using palliative orthoses in the single-use study evaluating gait (18.87 vs 42.06 without orthotics; p = 0.008).[27]
The effects of foot orthoses on gait are unclear; although the single-use study reported no improvements on gait with palliative orthoses,[27] the randomised study demonstrated improvements with orthotic footwear in mean normal velocity (6.4 cm/s) and stride length (5.5 cm), and in fast velocity (8.6 cm/s) and stride length (5.8 cm) [p < 0.05 vs baseline for all comparisons].[26]
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