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

NCT04784598 | Completed DMC

• 1 other identifier: UFRNheelpain
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Heel Pain Syndrome; Heel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Foot function - FFI

  baseline, 6 weeks after, 12 weeks after, 16 weeks folow up

• Change in Functional capacity - 6MWT

  baseline and 12 weeks after

• Change in Pain Catastrophizing Scale (PCS)

  baseline and 12 weeks after

• Expectation for treatment

  baseline

• Satisfaction with treatment

  16 weeks after

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Sham group

SHAM COMPARATOR

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

Interventions

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

Experimental group; Sham group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

Study Sites (1)

Marcelo Cardoso de Souza

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

Location

Related Publications (3)

• 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.

  PMID: 31808352 RESULT

• Fagundes MG, Mendes AAMT, Bezerra VF, Freitas WRMS, Scattone Silva R, Pontes-Silva A, Barbosa GM, Cardoso de Souza M. Effects of insoles adapted in flip-flop sandals in patients with persistent plantar heel pain: A sham-controlled randomised trial. Clin Rehabil. 2024 Nov;38(11):1466-1480. doi: 10.1177/02692155241267991. Epub 2024 Aug 2.

  PMID: 39094377 DERIVED

• 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.

  PMID: 36343988 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 5, 2021
• Study Start: May 16, 2022
• Primary Completion: October 1, 2022
• Study Completion: January 1, 2023
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)