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NCT Number: NCT04784598

Insoles Adapted in Flip-flop Sandals in People With Heel Pain

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.

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Key information

Conditions

Heel Pain Syndrome Heel

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marcelo Cardoso de Souza

Natal, Rio Grande do Norte, 59200-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insoles adapted in flip-flop sandals

Other

participants of both groups individually received a pair of customized flip-flop sandals, with or without foot pieces, covered with smooth synthetic leather

Primary outcomes

  1. Change in Numerical pain intensity scale - NPS

    Time frame: baseline, 6 weeks after, 12 weeks after, 16 weeks folow up

    Pain intensity will be evaluated with the 10-point Numerical Pain Rating Scale, where 0 is "pain-free" and 10 is "maximum pain.

Secondary outcomes

  1. Change in Foot function - FFI

    Time frame: baseline, 6 weeks after, 12 weeks after, 16 weeks folow up

    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

  2. Change in Functional capacity - 6MWT

    Time frame: baseline and 12 weeks after

    For this test, the participant walked at full speed for 6minutes along a 30-m lane, and the total distance was recorded.

  3. Change in Pain Catastrophizing Scale (PCS)

    Time frame: baseline and 12 weeks after

    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

  4. Expectation for treatment

    Time frame: baseline

    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

  5. Satisfaction with treatment

    Time frame: 16 weeks after

    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

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio Grande do Norte

Other

Registry information

Official study title

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

Acronym: Heelpain

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Mar 5, 2021
Registry last updated
Jan 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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