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Flexible Footwear and Insole in Heel Pain

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ClinicalTrials.gov Identifier: NCT03040557
Recruitment Status : Unknown
Verified February 2017 by Ana Paula Ribeiro, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : February 2, 2017
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Ana Paula Ribeiro, University of Sao Paulo

Brief 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 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 75 women with plantar fasciitis will be randomized and allocated to the intervention group with flexible footwear (GIC, acute n=15 and chronic=15) or the intervention group with orthopedic insole (GIP, 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), and the secondary: 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), the distance traveled by the six-minute walk test (6MWT), paracetamol consumption and the joint angles of the lower limbs, plantar pressure and ground reaction force during gait. 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.

Condition or disease Intervention/treatment Phase
Plantar Fasciitis of Right Foot (Disorder) Heel Spur Device: Flexible footwear Device: Orthopedic insole Phase 1 Phase 2

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 footwear (GIC), as the intervention group insole (GIP) 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 (GIC, acute n=15 and chronic=15) or the intervention group with orthopedic insole (GIP, 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), and the secondary: 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), the distance traveled by the six-minute walk test (6MWT), paracetamol consumption and the joint angles of the lower limbs, plantar pressure and ground reaction force during gait. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Therapeutic Effect of Flexible Footwear and Insoles on Clinical Aspects, Functional and Biomechanical of the Individuals With Heel Pain
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : February 1, 2017
Estimated Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Active Comparator: Flexible footwear
The intervention with flexible footwear in women with plantar fasciitis (GIC, acute n=15 and chronic=15) will have a duration will be six months, for six hours a day, seven days a week (42 hours / week).
Device: 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).

Active Comparator: Orthopedic insole
The intervention with orthopedic insole in women with plantar fasciitis (GIC, acute n=15 and chronic=15) will have a duration will be six months, for six hours a day, seven days a week (42 hours / week).
Device: 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).




Primary Outcome Measures :
  1. Symptom pain on foot [ Time Frame: Change from Symptom pain on foot at 6 months ]
    The primary outcome will be the symptom of pain verified by visual analogue scale (VAS/cm)


Secondary Outcome Measures :
  1. Anthropometric aspect [ Time Frame: Change from anthropometric at 6 months ]
    Assessments of the BMI in kg/m^2

  2. 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)

  3. 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)

  4. Six-minute walk test (6MWT) [ Time Frame: Change from 6MWT at 6 months ]
    The distance traveled by the six-minute walk test (6MWT in kilometers)

  5. Joint angles of the lower limbs [ Time Frame: Change from joint angle at 6 months ]
    The joint angles of knee and ankle by goniometer (degrees)

  6. Plantar pressure [ Time Frame: Change from plantar pressure at 6 months ]
    The peak pressure (kPa), contact area (cm) and contact time (ms) by platform pressure

  7. Ground reaction force [ Time Frame: Change from maximum force at 6 months ]
    Maximum Force (Newton/N) during gait

  8. 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 6 months ]
    For all groups will be allowed to use pain medication support (paracetamol 500 mg) with a maximum dose of two grams daily.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040557


Contacts
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Contact: Ana P. Ribeiro, Ph.D. 55 991392168 apribeiro@usp.br
Contact: Silvia Maria Amado João, Ph.D. 55 985537218 smaj@usp.br

Locations
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Brazil
University Hospital Rheumatology Clinic, Faculty of Medicine, University of São Paulo Recruiting
São Paulo, SP, Brazil, 056360160
Contact: Ana P. Ribeiro, Ph.D.    55 991392168    apribeiro@usp.br   
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Ana P. Ribeiro, Ph.D. University of the São Paulo

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Responsible Party: Ana Paula Ribeiro, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03040557     History of Changes
Other Study ID Numbers: APRibeiro
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ana Paula Ribeiro, University of Sao Paulo:
plantar fasciitis
shoes
insoles
pain
foot

Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Heel Spur
Musculoskeletal Diseases
Foot Diseases
Exostoses
Hyperostosis
Bone Diseases