An interventional study of Insoles adapted in flip-flop sandals in Heel Pain Syndrome and Heel, sponsored by Universidade Federal do Rio Grande do Norte. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-20.
Sponsored by Universidade Federal do Rio Grande do Norte · Not applicable, Interventional, and Treatment
Introduction: Persistent hindfoot pains are very common and prevalent complaints in the Brazilian population. One of the treatments recommended for these conditions in the literature is the use of insoles. However, to use this resource it is necessary that the individual wear closed shoes and this is an obstacle to treatment in cities with hot climate. Thinking about an alternative treatment, the customized slippers with the corrective elements of the insoles can be an alternative to increase adherence to this type of treatment. Objective: To compare different types of hindfoot elements in insoles adapted in slippers in individuals with persistent hindfoot pain.
Methodology: This is a protocol for a controlled, randomized, blinded clinical trial. Eighty participants with persistent hindfoot pain will be evaluated and randomized into two intervention groups: insoles adapted to flip-flops and flip-flops with sham insole. The evaluations will be carried out at baseline (T0), after six (T6) and twelve weeks (T12) of the use of flip-flops, in addition to the follow-up that will be carried out four weeks after the end of the intervention (T16). The primary outcome will be pain, using the Numerical Pain Scale and the secondary outcomes will be: foot function, using the Foot Function Index questionnaire, functional capacity in walking, using the Six-Minute Walk Test and pain catastrophizing using the Scale. of Pain Catastrophizing. Statistical analysis: Data will be analyzed by T-student, Mann-Whitney and repeated measures ANOVA tests and will be analyzed by intention to treat. Ethics and disclosure: This protocol was approved by the Ethics Committee of UFRN/FACISA (number 4,018,821). The results of the study will be disseminated to participants and submitted to a peer-reviewed journal and scientific meetings.
Universidade Federal do Rio Grande do Norte is the lead sponsor of 84 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Group 1- The intervention group I will receive a customized strip slipper with a 3mm EVA horseshoe piece (Shore A 32). And 2.5mm EVA cover (Shore A 28).
Other: Insoles adapted in flip-flop sandals
Group 2- The control group will receive a slipper with a 2.5mm EVA cover (Shore A 32) identical to the one used by the intervention group, but without corrective par
Other: Insoles adapted in flip-flop sandals
participants of both groups individually received a pair of customized flip-flop sandals, with or without foot pieces, covered with smooth synthetic leather
Change in Numerical pain intensity scale - NPS
Pain intensity will be evaluated with the 10-point Numerical Pain Rating Scale, where 0 is "pain-free" and 10 is "maximum pain.
Time frame: baseline, 6 weeks after, 12 weeks after, 16 weeks folow up
Change in Foot function - FFI
Brazilian version of the Foot Function Index questionnaire.15 This questionnaire aims to evaluate the functionality of the foot and is divided into three subscales, which are pain, difficulty and functional limitation. The outcome of all domains was summed and divided by three to achieve the final result of the questionnairewhich can vary from 0% to 100%, and are proportional to functional impairment of the limb.The higher the percentage, the greater the functional alteration presented by the patient
Time frame: baseline, 6 weeks after, 12 weeks after, 16 weeks folow up
Change in Functional capacity - 6MWT
For this test, the participant walked at full speed for 6minutes along a 30-m lane, and the total distance was recorded.
Time frame: baseline and 12 weeks after
Change in Pain Catastrophizing Scale (PCS)
Self-administered questionnaire composed of 13 items in which the individual reports the degree of thought or feeling on a 5-point Likert scale. The instrument has three subscales (hopelessness, magnification, and rumination), and the total score (0 to 52 points) is obtained by summing items. The higher the value, the greater the level of catastrophizing
Time frame: baseline and 12 weeks after
Expectation for treatment
The scale assesses the expectations of individuals at the beginning of the study regarding treatment received. The question "Do you think that with flip-flop sandals you will" (1) get very worse, (2) get a little worse, (3) neither improve nor get worse, (4) improve a little, or (5) improve a lot. This scale will be applied only in the first (T0) assessment
Time frame: baseline
Satisfaction with treatment
The scale will assess perceptions of the individual on the effects of treatment through the following question: "After using flip-flop sandals with insoles are you feeling" (1) much worse, (2) a little worse, (3) neither better nor worse, (4) a little better, or (5) much better
Time frame: 16 weeks after
Plan to share: No — there is not a plan to make individual participant data (IPD) available to other researchers
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Universidade Federal do Rio Grande do Norte