Flexible Footwear and Insole in Heel Pain

NCT03040557 | Completed DMC

• 1 other identifier: APRibeiro
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Plantar Fasciitis of Right Foot (Disorder); Heel Spur

Keywords

plantar fasciitis; shoes; insoles; pain; foot

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (3)

• Plantar pressure

  Change from plantar pressure at 3 and 6 months

• Ground reaction force

  Change from maximum force at 3 and 6 months

• For all groups will be allowed to use pain medication support for foot pain

  The groups will be allowed to use pain medication support for foot pain at 3 and 6 months

Study Arms (2)

Flexible footwear

ACTIVE COMPARATOR

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).

Device: Flexible footwear

Orthopedic insole

ACTIVE COMPARATOR

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).

Device: Orthopedic insole

Interventions

Flexible footwear DEVICE

\- 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).

Flexible footwear

Orthopedic insole DEVICE

\- 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).

Orthopedic insole

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

School of Medicine, University of São Paulo

São Paulo, São Paulo, 056360160, Brazil

Location

Related Publications (1)

• Ribeiro AP, de Souza BL, Joao SMA. Effectiveness of mechanical treatment with customized insole and minimalist flexible footwear for women with calcaneal spur: randomized controlled trial. BMC Musculoskelet Disord. 2022 Aug 13;23(1):773. doi: 10.1186/s12891-022-05729-4.

  PMID: 35964021 DERIVED

MeSH Terms

Conditions

Heel Spur; Fasciitis, Plantar; Pain

Condition Hierarchy (Ancestors)

Exostoses; Hyperostosis; Bone Diseases; Musculoskeletal Diseases; Foot Diseases; Fasciitis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ana Paula Ribeiro, Ph.D.

  University of the São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The intervention groups were: minimalist flexible footwear group-MFG (n=12 women with PF; n=15 women with CS), Orthopedic insole on minimalist footwear group-COIG (n=14 women with PF; n=14 women with CS) and control-GC group (n=24). Both groups were followed for six months and were assessed at baseline condition and after three and six months (end of intervention).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A randomized, parallel and controlled clinical trial with blind assessor was conducted in which 79 women were randomized and allocated to the intervention groups

Study Record Dates

• First Submitted: October 1, 2016
• First Posted: February 2, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 4, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)