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Plantar Fasciitis of Right Foot (Disorder)NCT03040557

Flexible Footwear and Insole in Heel Pain

A study testing Flexible footwear and Orthopedic insole in people with Plantar Fasciitis of Right Foot (Disorder) and Heel Spur, run by University of Sao Paulo 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

The plantar fasciitis (PF), most frequent injury of the musculoskeletal system, is the main cause of heel pain and functional disability. The mechanical stress, stretching of plantar fascia consequently the overload on the feet, is a major intrinsic causes the onset of FP, especially when exposed to repetitive… Read more about this study

Who is it for?
Ages 30 to 50 years, women onlyHealthy volunteers can take part
What is being tested?
Flexible footwear and Orthopedic insole
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteBrazil
Study dates
1 Jan 2017to 1 Dec 2019
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 30 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Women volunteers aged between 30 and 50 years
  • Diagnosis of plantar fasciitis (PF) or heel spur
  • Healthy women
  • Body mass index (BMI) less than 35 kg/m2

Who cannot join

  • Difference in length of the lower limbs greater than 1 cm
  • Surgical procedure on the knees, ankles and hips or muscle injury in the last 6 months
  • Diagnosed neurological and rheumatic disease
  • Rigid hallux
  • Conservative treatment for PF, except drug
  • Walk dependent with prostheses and / or orthoses in the lower limbs
Show all 9Show fewer
  • Corticosteroid injection in the heel in previous periods of three and six months, respectively
  • Joint instability ankle
  • Dementia or inability to provide information consistent

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • School of Medicine, University of São Paulo

    São Paulo, São Paulo, 056360160

Other trials in Brazil

About this study

Official title: Therapeutic Effect of Minimalist Flexible Footwear and Insoles on Clinical, Functional and Biomechanical Aspects of the Individuals With Plantar Fasciitis and Calcaneus Spur

The plantar fasciitis (PF), most frequent injury of the musculoskeletal system, is the main cause of heel pain and functional disability. The mechanical stress, stretching of plantar fascia consequently the overload on the feet, is a major intrinsic causes the onset of FP, especially when exposed to repetitive activities, such as walking. Another extrinsic etiologic factor of great influence is inadequate shoes that can lead to a deterioration and progression of the disease. One of the great difficulties of their conservative treatment is long rehabilitation period, lasting on average 10 to 18 months. Among them, the insoles stand out as one of the effective mechanical treatments to improve the immediate pain symptoms, in the short term. Other literary evidence, not specific to FP, has shown the benefits, the short and long term, a flexible footwear promotes more flexible feet and overload reduction. Objective: Verify therapeutic effect in the long term, a flexible footwear and low cost and orthopedic insole on the clinical aspect, functional and biomechanics of the gait of women with acute FP and chronic with presence of heel spur. It will be conducted a randomized controlled trial with blinded evaluator, in which 79 women with plantar fasciitis will be randomized and allocated to the intervention group with minimalist flexible footwear (MFG, acute n=12 and chronic=15) or the intervention group with orthopedic insole (COIG, acute n=14 and chronic n=14) or control group (CG, n=24). The intervention will have duration six months, six hours a day, seven days a week (42 hours/week). For all groups will be allowed to use pain medication support (paracetamol 500 mg) with a maximum dose of two grams daily. The primary outcome will be the symptom of pain verified by visual analogue scale (VAS), the inability to areas of the feet by the total score of the FFI (Foot Function Index), health feet by FHSQ-Br questionnaire (Foot Health Questionnaire Status) and the distance traveled by the six-minute walk test (6MWT). The secondary: plantar pressure and ground reaction force during gait, paracetamol consumption and the joint angles of the lower limbs. The effects of time (Start, 3 and 6 months), group (GIC and GIP CG) and interaction (time and group) are calculated by means of ANOVA case-wise two factors. A 5% alpha to significant differences and Cohen coefficient for describing the size effect of the intervention is assumed.

Read the detailed description

A prospective controlled study with random allocation. The independent variable (group) has three levels: intervention with flexible footwear, intervention with custom orthopedic insoles and control without intervention, only with medical conservative treatment. This independent variable is related to the set of dependent variables stemmed from clinical, functional and biomechanical data. All groups, both will use the intervention minimalist flexible footwear (MFG), as the intervention group insole (COIG) and the group that did not receive intervention (GC) shall consist of patients with PF (plantar fasciitis) in different stages of the disease.These will be required to fit in all the pre-established criteria for diagnosis of the disease confirmed by physical examination, X-ray and ultrasound. Patients in the group with chronic fasciitis plantar associated with heel spur should necessarily present themselves diagnosed radiographically by the doctor that came in the Rheumatology Clinic of the University. All participants will be informed of the procedures in this research through a free and informed consent form, prepared in accordance with Resolution 466/12 of the National Health Board. The eligibility criteria for this study will be: female volunteers aged between 30 and 50 years, body mass index (BMI) less than 35 kg / m2, no history of any surgical procedure on knees, ankles and hips or muscle injury in the last 6 months and no neurological and rheumatologic disease diagnosed. Furthermore, they may not show difference in length of the lower limbs greater than 1 cm and rigid hallux and performing some kind of conservative treatment for PF, except drug. Patients should be able to walk independently for at least 6 hours a day without the aid of orthotics / canes to perform their activities of daily living. There may also have prostheses and / or orthoses in the lower limbs. Patients may not have received corticosteroid injection in the heel in previous periods of three and six months, respectively. In addition to these criteria, patients may not present: joint instability ankle (positive test results of the medial ligament and lateral), dementia or inability to provide information consistent.It will be conducted a randomized controlled trial with blinded evaluator, in which 75 women with plantar fasciitis will be randomized and allocated to the intervention group with flexible footwear (MFG, acute n=15 and chronic=15) or the intervention group with orthopedic insole (COIG, acute n=15 and chronic n=15) or control group (CG, n=15). The intervention will have duration six months, six hours a day, seven days a week (42 hours/week). For all groups will be allowed to use pain medication support (paracetamol 500 mg) with a maximum dose of two grams daily. The primary outcome will be the symptom of pain verified by visual analogue scale (VAS), the inability to areas of the feet by the total score of the FFI (Foot Function Index), health feet by FHSQ-Br questionnaire (Foot Health Questionnaire Status) and the distance traveled by the six-minute walk test (6MWT). The secondary: plantar pressure and ground reaction force during gait, paracetamol consumption and the joint angles of the lower limbs. The effects of time (Start, 3 and 6 months), group (GIC and GIP CG) and interaction (time and group) are calculated by means of ANOVA case-wise two factors. A 5% alpha to significant differences and Cohen coefficient for describing the size effect of the intervention is assumed.

Being tested
Flexible footwear, Orthopedic insole
Keywords
plantar fasciitis, shoes, insoles, pain, foot
Medical subject headings
Heel Spur, Fasciitis, Plantar, Pain

What participants receive

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

  • Flexible footwearDevice

    • Arm Flexible footwear: The intervention will be with flexible shoes in women with plantar fasciitis (acute and chronic) and will have a duration will be six months, for six hours a day, seven days a week (42 hours / week).
  • Orthopedic insoleDevice

    • Arm Orthopedic insole: The intervention will be with orthopedic insole in women with plantar fasciitis (acute and chronic) and will have a duration will be six months, for six hours a day, seven days a week (42 hours / week).
Study groups in NCT03040557
Study groupRoleWhat they receive
Flexible footwearActive comparatorThe intervention with flexible footwear in women with plantar fasciitis (MFG), acute n=12 and chronic=15) will have a duration will be six months, for six hours a day, seven days a week (42 hours / week).
Receives: Device: Flexible footwear
Orthopedic insoleActive comparatorThe intervention with orthopedic insole in women with plantar fasciitis (COIG, acute n=14 and chronic=14) will have a duration will be six months, for six hours a day, seven days a week (42 hours / week).
Receives: Device: Orthopedic insole

What is being measured

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

  1. Symptom pain on foot

    The primary outcome will be the symptom of pain verified by visual analogue scale (VAS/cm)

    Measured: Change from Symptom pain on foot at 3 and 6 months

  2. Foot Function Index (FFI)

    The domains of disability feet by the all score of the FFI (Foot Function Index in score)

    Measured: Change from domains of the FFI at 6 months

  3. Foot Health Status Questionnaire (FHSQ-Br)

    Health feet by FHSQ-Br questionnaire (Foot Health Status Questionnaire in units)

    Measured: Change from FHSQ-Br at 6 months

  4. Six-minute walk test (6MWT)

    The distance traveled by the six-minute walk test (6MWT in kilometers)

    Measured: Change from 6MWT at 3 and 6 months

Secondary outcomes (3)
  1. Plantar pressure

    The peak pressure (kPa), contact area (cm) and contact time (ms) by platform pressure

    Measured: Change from plantar pressure at 3 and 6 months

  2. Ground reaction force

    Maximum Force (Newton/N) during gait

    Measured: Change from maximum force at 3 and 6 months

  3. For all groups will be allowed to use pain medication support for foot pain

    For all groups will be allowed to use pain medication support (paracetamol 500 mg) with a maximum dose of two grams daily.

    Measured: The groups will be allowed to use pain medication support for foot pain at 3 and 6 months

Timeline

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

  1. First posted2 Feb 2017 (estimated)
  2. Study start1 Jan 2017
  3. Primary completion1 Dec 2019
  4. Study completion1 Dec 2019

Resources

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
A randomized, parallel and controlled clinical trial with blind assessor was conducted in which 79 women were randomized and allocated to the intervention groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03040557
Sponsor's protocol ID
APRibeiro
Status last verified
Apr 2020
First submitted
1 Oct 2016
Last updated
4 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ribeiro AP, de Souza BL, Joao SMA. Effectiveness of mechanical treatment with customized insole and minimalist flexible footwear for women with calcaneal spur: randomized controlled trial. BMC Musculoskelet Disord. 2022 Aug 13;23(1):773. doi: 10.1186/s12891-022-05729-4.

    PubMed 35964021

Questions about this trial

What is this clinical trial studying?

A study testing Flexible footwear and Orthopedic insole in people with Plantar Fasciitis of Right Foot (Disorder) and Heel Spur, run by University of Sao Paulo 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 9 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 4 May 2020. 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. 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?

Symptom pain on foot (time frame: Change from Symptom pain on foot at 3 and 6 months). The study lists 4 primary outcomes in all. 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 NCT03040557, which also lists 1 linked publication.

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 4 May 2020.

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