Flexible Footwear and Insole in Heel Pain
Condition: Plantar Fasciitis of Right Foot (Disorder); Heel Spur
MeSH terms: Fasciitis; Fasciitis, Plantar; Heel Spur
Study type: Interventional

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 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.
    

Intervention name(s): Flexible footwear; Orthopedic insole
Intervention type(s): Device; Device
Intervention description(s): - 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).; - 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: plantar fasciitis; shoes; insoles; pain; foot