Insoles Adapted in Flip-flop Sandals in People With Heel Pain
Condition: Heel Pain Syndrome; Heel
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Insoles adapted in flip-flop sandals
Intervention type(s): Other
Intervention description(s): participants of both groups individually received a pair of customized flip-flop sandals, with or without foot pieces, covered with smooth synthetic leather
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1- (n=40) The participant allocated to the insoles group adapted to flip-flops and classified as having a neutral foot according to the FPI-6 will receive a flip-flop with a horseshoe-type foot element on both feet to maintain symmetry between the limbs.
If the participant is classified with the foot pronated or supinated, only the painful foot will be modified since the symmetry of the limbs will not be modified. Participants with pronated foot will receive the medial wedge as a pedal element; already the participants with supinated foot, the lateral wedge. All elements will be 3mm and produced with EVA Shore 32.
• Group 2- The control group (n=40) 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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment