- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03040557
Flexible Footwear and Insole in Heel Pain
April 29, 2020 updated by: Ana Paula Ribeiro, University of Sao Paulo
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
-
São Paulo, SP, Brazil, 056360160
- School of Medicine, University of Sao Paulo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion criteria:
- 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
Exclusion criteria:
- 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
- Corticosteroid injection in the heel in previous periods of three and six months, respectively
- Joint instability ankle
- Dementia or inability to provide information consistent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Flexible footwear
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).
|
- 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).
|
Active Comparator: Orthopedic insole
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).
|
- 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Change from Symptom pain on foot at 3 and 6 months
|
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)
|
Change from domains of the FFI at 6 months
|
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)
|
Change from FHSQ-Br at 6 months
|
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)
|
Change from 6MWT at 3 and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plantar pressure
Time Frame: Change from plantar pressure at 3 and 6 months
|
The peak pressure (kPa), contact area (cm) and contact time (ms) by platform pressure
|
Change from plantar pressure at 3 and 6 months
|
Ground reaction force
Time Frame: Change from maximum force at 3 and 6 months
|
Maximum Force (Newton/N) during gait
|
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
|
For all groups will be allowed to use pain medication support (paracetamol 500 mg) with a maximum dose of two grams daily.
|
The groups will be allowed to use pain medication support for foot pain at 3 and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ana Paula Ribeiro, Ph.D., University of the São Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
December 1, 2019
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
October 1, 2016
First Submitted That Met QC Criteria
January 31, 2017
First Posted (Estimate)
February 2, 2017
Study Record Updates
Last Update Posted (Actual)
May 4, 2020
Last Update Submitted That Met QC Criteria
April 29, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APRibeiro
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heel Spur
-
Ankara City Hospital BilkentCompleted
-
Hilal YeşilCompletedCalcaneal SpurTurkey
-
Bezmialem Vakif UniversityRecruitingHeel Spur | Heel Spur Syndrome | Heel Pain SyndromeTurkey
-
Imam Abdulrahman Bin Faisal UniversityCompletedPlantar Fasciitis | Chronic Plantar Fasciitis | Heel Spur Syndrome
-
Medical University of LodzUnknownHeel Spur | Calcaneal SpurPoland
-
Meir Medical CenterClalit Health ServicesCompletedFasciitis, Plantar | Plantar Calcaneal SpurIsrael
-
Beni-Suef UniversitySelfNot yet recruiting
-
Yuzuncu Yıl UniversityCompleted
-
Medical University of LodzCompleted
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalRecruiting
Clinical Trials on Flexible footwear
-
University of Sao Paulo General HospitalCompleted
-
Staffordshire UniversityIndia Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes HospitalsCompletedDiabetes Complications | Diabetic NeuropathiesIndia
-
High Point UniversityAdidas International, Inc.CompletedFoot | FootwearUnited States
-
Universidad Complutense de MadridCompletedDiabetic Foot | Diabetic Foot UlcerSpain
-
VA Office of Research and DevelopmentUniversity of Nebraska; Results Group LLCRecruiting
-
University of AarhusAarhus University HospitalCompleted
-
Universidade do AlgarveUniversity of Huelva; OKM Química Ortopédica S.L.; Lola - J. Andrade Ferreira... and other collaboratorsCompletedDiabetes Mellitus, Type 2 | Diabetic Peripheral NeuropathyPortugal
-
Palacky UniversityCompleted
-
Tuba MadenCompletedAging | Aging Problems | Aging Disorder
-
University of Massachusetts, AmherstRecruitingArthralgia | Joint Stiffness | Gait MechanicsUnited States