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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-16

Study Completion Date

2023-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effectiveness of Postural Insoles Adapted in Slippers for People With Persistent Heel Pain

NCT03482518

Heel Pain Syndrome Metatarsalgia

COMPLETED NA

Flexible Footwear and Insole in Heel Pain

NCT03040557

Plantar Fasciitis of Right Foot (Disorder) Heel Spur

COMPLETED NA

Effects of Customized Insoles for Individuals With Symptomatic Hallux Valgus

NCT05408156

Hallux Valgus Foot Diseases Foot Deformities

NOT_YET_RECRUITING NA

Plantar Fasciitis Foot Insole

NCT01549678

Plantar Fasciitis

UNKNOWN NA

Effects of Kinesio Taping and Extracorporeal Shock Wave Therapy in the Calcaneal Spur

NCT06533683

Calcaneal Spur Plantar Fasciitis Heel Pain

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heel Pain Syndrome Heel

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

Insoles adapted in flip-flop sandals

Intervention Type OTHER

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

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

Group Type SHAM_COMPARATOR

Insoles adapted in flip-flop sandals

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes