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.
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
- Conditions the study is for
- Plantar Fasciitis of Right Foot (Disorder), Heel Spur
- 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
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 group | Role | What they receive |
|---|---|---|
| Flexible footwear | Active comparator | The 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 insole | Active comparator | The 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.
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
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
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
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)
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
Ground reaction force
Maximum Force (Newton/N) during gait
Measured: Change from maximum force at 3 and 6 months
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.
- First posted2 Feb 2017 (estimated)
- Study start1 Jan 2017
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plantar Fasciitis of Right Foot (Disorder)Studies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- 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)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Paula Ribeiro, University of Sao Paulo
- Investigators
- Ana Paula Ribeiro, Ph.D., Principal investigator, University of the São Paulo
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
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03040557
- Acronym / sponsor ID
- APRibeiro
- Keywords
- plantar fasciitis, shoes, insoles, pain, foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 2 Feb 2017 (estimated)
- 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Flexible footwear | Active comparator | Device: Flexible footwearThe 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). |
| Orthopedic insole | Active comparator | Device: Orthopedic insoleThe 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). |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Flexible footwear- 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). | Device | Flexible footwear |
| Orthopedic insole- 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). | Device | Orthopedic insole |
Primary outcome
Symptom pain on foot
Time frame: Change from Symptom pain on foot at 3 and 6 months
The primary outcome will be the symptom of pain verified by visual analogue scale (VAS/cm)
Foot Function Index (FFI)
Time frame: Change from domains of the FFI at 6 months
The domains of disability feet by the all score of the FFI (Foot Function Index in score)
Foot Health Status Questionnaire (FHSQ-Br)
Time frame: Change from FHSQ-Br at 6 months
Health feet by FHSQ-Br questionnaire (Foot Health Status Questionnaire in units)
Six-minute walk test (6MWT)
Time frame: Change from 6MWT at 3 and 6 months
The distance traveled by the six-minute walk test (6MWT in kilometers)
3 secondary outcomes
Plantar pressure
Time frame: Change from plantar pressure at 3 and 6 months
Ground reaction force
Time frame: Change from maximum force at 3 and 6 months
For all groups will be allowed to use pain medication support for foot pain
Time frame: The groups will be allowed to use pain medication support for foot pain at 3 and 6 months
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 4 May 2020.
- Derived from this study: PubMed 35964021Ribeiro 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.
- Individual participant dataSharing planned: No
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.
Ana Paula Ribeiro, Ph.D. principal investigator
University of the São Paulo
1 site in 1 country: see every site and its status.
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.