Heel Spur Clinical Trial
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
Verified date | April 2020 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 65 |
Est. completion date | December 1, 2019 |
Est. primary completion date | December 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 30 Years to 50 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | School of Medicine, University of São Paulo | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptom pain on foot | 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 | |
Primary | Foot Function Index (FFI) | 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 | |
Primary | Foot Health Status Questionnaire (FHSQ-Br) | Health feet by FHSQ-Br questionnaire (Foot Health Status Questionnaire in units) | Change from FHSQ-Br at 6 months | |
Primary | Six-minute walk test (6MWT) | The distance traveled by the six-minute walk test (6MWT in kilometers) | Change from 6MWT at 3 and 6 months | |
Secondary | Plantar pressure | The peak pressure (kPa), contact area (cm) and contact time (ms) by platform pressure | Change from plantar pressure at 3 and 6 months | |
Secondary | Ground reaction force | Maximum Force (Newton/N) during gait | Change from maximum force at 3 and 6 months | |
Secondary | 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. | The groups will be allowed to use pain medication support for foot pain at 3 and 6 months |
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