Clinical Trial: Flexible Footwear and Insole in Heel Pain

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Therapeutic Effect of Flexible Footwear and Insoles on Clinical Aspects, Functional and Biomechanical of the Individuals With Heel Pain

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

Detailed Summary: 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, r
Sponsor: University of Sao Paulo

Current Primary Outcome: Symptom pain on foot [ Time Frame: Change from Symptom pain on foot at 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Anthropometric aspect [ Time Frame: Change from anthropometric at 6 months ]
  Assessments of the BMI in kg/m^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)
• 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 6 months ]
  The distance traveled by the six-minute walk test (6MWT in kilometers)
• 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)
• 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
• Ground reaction force [ Time Frame: Change from maximum force at 6 months ]
  Maximum Force (Newton/N) during gait
• 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.

Original Secondary Outcome:

• Anthropometric aspect [ Time Frame: Change from anthropometric at 6 months ]
  Assessments of the BMI in kg/m^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)
• Foot Health Status Questinnarie (FHSQ-Br) [ Time Frame: Change from FHSQ-Br at 6 months ]
  Health feet by FHSQ-Br questionnaire (Foot Health Status Questinnarie in units)
• 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)
• 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)
• 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
• Ground reaction force [ Time Frame: Change from maximum force at 6 months ]
  Maximum Force (Newton/N) during gait
• Paracetamol consumption [ Time Frame: Change from paracetamol consumption force at 6 months ]
  Amount of paracetamol (milligram/mg)

Information By: University of Sao Paulo

Dates:
Date Received: October 1, 2016
Date Started: January 1, 2017
Date Completion: April 1, 2018
Last Updated: February 2, 2017
Last Verified: February 2017