Insoles Adapted in Flip-flop Sandals in People With Heel Pain (Heelpain)

Effects of Insoles Adapted in Flip-flop Sandals in People With Heel Pain: a Randomized, Double-blind Clinical, Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Heel Pain Syndrome; Heel
• Intervention / Treatment: Other: Insoles adapted in flip-flop sandals

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RN
    • Natal, RN, Brazil, 59200-000
      • Marcelo Cardoso de Souza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Individuals of both sexes, aged 18 to 65 years;
• Persistent heel pain for at least three months based on self-reported criteria: heel pain accompanying the first steps in the morning, after a period of inactivity, and/or during prolonged weight-bearing;
• Pain intensity between 3 and 8 points, according to the Numerical Rating Scale (NRS) [22];
• Individuals who can wear flip-flop sandals for at least four hours per day for 12 weeks.

Exclusion Criteria:

• Clinical diagnosis of neuropathic pain or neurodegenerative disorders, persistent heel pain due to rheumatic conditions, and previous ankle and foot surgeries;
• Physical therapy treatment in the last three months;
• Corticosteroid injection into feet in the last six months;
• inability to answer study-related questionnaires;
• Individuals scheduled to travel in the next six months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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; participants of both groups individually received a pair of customized flip-flop sandals, with or without foot pieces, covered with smooth synthetic leather
Sham Comparator: Sham group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, 6 weeks after, 12 weeks after, 16 weeks folow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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	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	16 weeks after

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio Grande do Norte

Publications and helpful links

General Publications

• Costa ARA, de Almeida Silva HJ, Mendes AAMT, Scattone Silva R, de Almeida Lins CA, de Souza MC. Effects of insoles adapted in flip-flop sandals in people with plantar fasciopathy: a randomized, double-blind clinical, controlled study. Clin Rehabil. 2020 Mar;34(3):334-344. doi: 10.1177/0269215519893104. Epub 2019 Dec 6.
• Fagundes MG, Teixeira Mendes AAM, Barbosa GM, de Souza MC. Effects of insoles adapted in flip-flop sandals for persistent heel pain: a protocol for a sham-controlled randomised trial. BMJ Open. 2022 Nov 7;12(11):e062523. doi: 10.1136/bmjopen-2022-062523.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2022
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: UFRNheelpain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: there is not a plan to make individual participant data (IPD) available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No