Heel Pain SyndromeHeelpainNCT04784598

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

A study testing Insoles adapted in flip-flop sandals in people with Heel Pain Syndrome and Heel, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Heel Pain Syndrome, Heel
What is being tested?: Insoles adapted in flip-flop sandals
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteBrazil
Study dates: 16 May 2022to 1 Jan 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Marcelo Cardoso de Souza
Natal, Rio Grande do Norte, 59200-000

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Conditions: Heel Pain Syndrome, Heel
Being tested: Insoles adapted in flip-flop sandals

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04784598
Study group	Role	What they receive
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). Receives: 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 Receives: Other: Insoles adapted in flip-flop sandals

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: baseline, 6 weeks after, 12 weeks after, 16 weeks folow up

Secondary outcomes (5)

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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 16 weeks after

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 May 20221 Jan 2023

First posted5 Mar 2021
Study start16 May 2022
Primary completion1 Oct 2022
Study completion1 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Heel Pain SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04784598
Sponsor's protocol ID: UFRNheelpain
Acronym: Heelpain
Status last verified: Jan 2023
First submitted: 1 Mar 2021
Last updated: 20 Jan 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: there is not a plan to make individual participant data (IPD) available to other researchers

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.
PubMed 31808352
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.
PubMed 39094377
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.
PubMed 36343988

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Heel Pain Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Insoles Adapted in Flip-flop Sandals in People With Heel Pain: a Randomized, Double-blind Clinical, Controlled Study
ClinicalTrials.gov ID: NCT04784598
Acronym / sponsor ID: Heelpain / UFRNheelpain
Conditions: Heel Pain Syndrome, Heel
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Universidade Federal do Rio Grande do NorteUniversity, hospital or other
Study start: 16 May 2022 (actual)
Primary completion: 1 Oct 2022 (actual)
Study completion: 1 Jan 2023 (actual)
First posted: 5 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Experimental group	Experimental	Other: Insoles adapted in flip-flop sandalsGroup 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).
Sham group	Sham comparator	Other: Insoles adapted in flip-flop sandalsGroup 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

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Insoles adapted in flip-flop sandalsparticipants of both groups individually received a pair of customized flip-flop sandals, with or without foot pieces, covered with smooth synthetic leather	Other	Experimental group, Sham group

Primary outcome

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.

5 secondary outcomes

Change in Foot function - FFI
Time frame: baseline, 6 weeks after, 12 weeks after, 16 weeks folow up
Change in Functional capacity - 6MWT
Time frame: baseline and 12 weeks after
Change in Pain Catastrophizing Scale (PCS)
Time frame: baseline and 12 weeks after
Expectation for treatment
Time frame: baseline
Satisfaction with treatment
Time frame: 16 weeks after

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
Results publication: PubMed 31808352Costa 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.
Derived from this study: PubMed 39094377Fagundes 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.
Derived from this study: PubMed 36343988Fagundes 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.
Individual participant dataSharing planned: No. there is not a plan to make individual participant data (IPD) available to other researchers

Related trials for Heel Pain Syndrome

Not yet recruiting
Acupuncture for Heel Pain Syndrome
Heel Pain Syndrome
Recruiting
Individualized Rehabilitation for Osgood-Schlatter or Sever Pain in Youth Athletes
Osgood-Schlatter Disease, Sever's Disease
Not yet recruiting
Baxter's Nerve Pulsed Radiofrequency Versus Platelet-Rich Plasma Injection or Both Together as a Treatment Modality of Recalcitrant Plantar Fasciitis
Plantar Fasciitis, Heel Pain
Not yet recruiting
Effect of Kaltenborn vs Mulligan Mobilization With Intrinsic Foot Strengthening in Plantar Fasciitis
Plantar Fascitis, Heel Pain Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Insoles adapted in flip-flop sandals in people with Heel Pain Syndrome and Heel, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Numerical pain intensity scale - NPS (time frame: baseline, 6 weeks after, 12 weeks after, 16 weeks folow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04784598, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.