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

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ClinicalTrials.gov Identifier: NCT04784598
Recruitment Status : Not yet recruiting
First Posted : March 5, 2021
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
Marcelo Cardoso de Souza, PT, PhD., Universidade Federal do Rio Grande do Norte

Brief 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.

Condition or disease Intervention/treatment Phase
Heel Pain Syndrome Heel Other: Insoles adapted in flip-flop sandals Not Applicable

Detailed Description:
Methodology: This is a clinical, controlled and randomized, double-blind study, in which 81 patients with a diagnosis of persistent hindfoot pain will be evaluated and randomized into 3 groups. Group 1 will receive a customized slipper with 3mm horseshoe foot pieces and 2.5mm EVA cover (shore A 28). Group 2 will receive a customized slipper with 3mm medial / lateral wedge foot pieces and 2.5mm EVA cover (shore A 28). Group 3, considered to be control, will receive a plain slipper with no elements, only with an EVA cover of 2.5 mm (shore A 28) with the same characteristics as the intervention groups. The evaluator and the patient will be considered blind. The evaluations will be carried out at the beginning (T0), after 12 weeks of wearing the slippers (T12) and a reassessment at week 16 (T16) to monitor the pain. The primary outcome will be pain (numerical pain scale); secondarily the foot posture (Foot Posture Index), functionality by the FFI - Foot Function Index questionnaire to assess functionality, and finally the 6-minute walk test for walking performance. Statistical analysis: The data will be analyzed by t-student tests, Mann-Whitney test, repeated measures ANOVA and analysis by intention to treat.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Group 1- The intervention group I (n = 27) will receive a customized strip slipper with a 3mm EVA horseshoe piece (Shore A 28). And 2.5mm EVA cover (Shore A 28).

  • Group 2- Intervention group II (n = 27) will receive a customized slipper with a 3mm EVA medial / lateral wedge piece (Shore A 42). And 2.5mm EVA cover (Shore A 28).
  • Group 3- The control group (n = 27) will receive a slipper with a 2.5mm EVA cover (Shore A 28) identical to the one used by the intervention group, but without corrective par
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Insoles Adapted in Flip-flop Sandals in People With Heel Pain: a Randomized, Double-blind Clinical, Controlled Study
Estimated Study Start Date : August 2, 2021
Estimated Primary Completion Date : August 2, 2022
Estimated Study Completion Date : August 2, 2023

Arm Intervention/treatment
Experimental: horseshoe piece group
Group 1- The intervention group I (n = 27) will receive a customized strip slipper with a 3mm EVA horseshoe piece (Shore A 28). 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

Experimental: medial / lateral wedge piece group
Group 2- Intervention group II (n = 27) will receive a customized slipper with a 3mm EVA medial / lateral wedge piece (Shore A 42). 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 3- The control group (n = 27 ) will receive a slipper with a 2.5mm EVA cover (Shore A 28) 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




Primary Outcome Measures :
  1. Change in Numerical pain intensity scale - NPS [ Time Frame: baseline, 12 weeks after. ]
    Pain intensity will be evaluated with the 10-point Numerical Pain Rating Scale, where 0 is "pain-free" and 10 is "maximum pain.


Secondary Outcome Measures :
  1. Change in Foot function - FFI [ Time Frame: baseline, 12 weeks after. ]
    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, 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients of both sexes diagnosed with persistent hindfoot pain and / for more than 3 months, aged 18 to 70 years old, used to wearing slippers, who are not undergoing other types of physical therapy.

Exclusion Criteria:

  • Patients with wounds on their feet, diabetes, previous surgeries on their feet and ankles, rheumatic diseases and / or skin diseases and those who report not being able to wear slippers or with recent trauma to their feet or lower limbs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04784598


Contacts
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Contact: Marcelo C de Souza, PT, PhD 55 (84)3291-2411 marcellogv@hotmail.com

Locations
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Brazil
Marcelo Cardoso de Souza
Santa Cruz, RN, Brazil, 59200-000
Sponsors and Collaborators
Universidade Federal do Rio Grande do Norte
Publications of Results:
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Responsible Party: Marcelo Cardoso de Souza, PT, PhD., Adjunct Professor, Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier: NCT04784598    
Other Study ID Numbers: UFRNheelpain
First Posted: March 5, 2021    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: there is not a plan to make individual participant data (IPD) available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No