The Therapeutic Effect of Targeted Intrinsic Foot Muscles Exercises in Plantar Fasciitis

Study Overview
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Brief Summary
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A reduction of intrinsic foot muscle sizes has been identified in patients with chronic plantar fasciitis. Weaker intrinsic foot muscles has been suggested to decrease the medial longitudinal arch height and subsequently increase extra tensile stress in the plantar fascia, resulting in the chronicity of the condition. Therefore, it is speculated that atrophic intrinsic foot muscles may be a significant risk factor of developing chronic plantar fasciitis. The purpose of this study is to investigate the effect of an 8-week targeted intrinsic foot muscles exercise regimen on the intrinsic foot muscle size, symptomatic relief, and foot function improvement in long-distance runners with chronic plantar fasciitis.

Detailed Description
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Distance runners are defined as running with more than 20km per week for more than 2 years. All recruited participants have > 1 year of plantar fasciitis. The diagnosis were made based on clinical symptoms and the thickness of plantar fasciitis > 4.0mm at the medial tubercle of heel by ultrasound imaging. Arm 1: The purpose of this arm of the study is to determine if a 8-week targeted foot muscle exercise regimen, instructed with real-time ultrasound, affect the intrinsic foot muscle size, symptomatic relief, and foot function improvement of distance runners with plantar fasciitis. 32 participants will be recruited in this arm. Arm 2: This group will not engage in any training, but will serve as a comparator for the intervention arm.

Official Title
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The Therapeutic Effect of Targeted Intrinsic Foot Muscles Exercises in Plantar Fasciitis

Conditions
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Plantar Fasciitis, Chronic, Pain

Intervention / Treatment
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* Other: targeted intrinsic foot muscle exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A weekly mileage of at least 20km Have running experience of at least 2 years prior to the experiment if they reported tenderness on palpation of the medial calcaneal tuberosity and exhibited one of the following complaints: Plantar heel pain > 1 year Pain on visual analog scale of equal to or greater than 4 out of 10 pain on the first step in the morning or after prolonged sitting, pain on prolonged standing and/or walking pain when running Exclusion Criteria: Contraindications to MRI scans had undergone surgery to the plantar fascia or local steroid injection within the last 3 months or Any of the following conditions: systemic arthritis, neurologic conditions any coexisting painful musculoskeletal condition of the lower limb.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with one intervention arm and one control arm
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Targeted intrinsic foot muscles exercise regimen<br>4 targeted intrinsic foot exercise will be performed at least 5 times per week, once in the laboratory, and four times at home. The participants will be followed up weekly at the laboratory visit. The real-time ultrasound imaging of intrinsic foot muscles will be used as guided visual biofeedback to instruct all participants to execute all exercise movement in a correct manner. If the participant misses a session, he/she is expected to replace the lost session within the same week. | Other: targeted intrinsic foot muscle exercises<br>* 4 targeted intrinsic foot muscle exercises<br>|
| No Intervention: Control<br>continue normal physical activity, | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP) | ultrasound measurement | baseline | 
| muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP) | ultrasound measurement | week 4 | 
| muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP) | ultrasound measurement | week 8 | 
| muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP) | ultrasound measurement | week 12 | 
| cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP) | ultrasound measurement | Baseline | 
| cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP) | ultrasound measurement | week 4 | 
| cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP) | ultrasound measurement | week 8 | 
| cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP) | ultrasound measurement | week 12 | 
| Visual Analog Scale (VAS) pain at first steps in the morning | measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain) | baseline | 
| Visual Analog Scale (VAS) pain at first steps in the morning | measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain) | week 4 | 
| Visual Analog Scale (VAS) pain at first steps in the morning | measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain) | week 8 | 
| Visual Analog Scale (VAS) pain at first steps in the morning | measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain) | week 12 | 
| Visual Analog Scale (VAS) worst pain of the day | measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain) | baseline | 
| Visual Analog Scale (VAS) worst pain of the day | measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain) | 4 | 
| Visual Analog Scale (VAS) worst pain of the day | measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain) | 8 | 
| Visual Analog Scale (VAS) worst pain of the day | measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain) | 12 | 
| Foot and Ankle Ability Measure (FAAM) | Higher scores represent higher levels of function, with 100% representing no dysfunction. | baseline | 
| Foot and Ankle Ability Measure (FAAM) | Higher scores represent higher levels of function, with 100% representing no dysfunction. | week 4 | 
| Foot and Ankle Ability Measure (FAAM) | Higher scores represent higher levels of function, with 100% representing no dysfunction. | week 8 | 
| Foot and Ankle Ability Measure (FAAM) | Higher scores represent higher levels of function, with 100% representing no dysfunction. | week 12 | 
| Foot posture index | Pronated postures are given a positive value, the higher the value the more pronated. Supinated features are given a negative value, the more negative the value the more supinated. For a neutral foot the final score should lie somewhere around zero | baseline | 
| Foot posture index | Pronated postures are given a positive value, the higher the value the more pronated. Supinated features are given a negative value, the more negative the value the more supinated. For a neutral foot the final score should lie somewhere around zero | week 4 | 
| Foot posture index | Pronated postures are given a positive value, the higher the value the more pronated. Supinated features are given a negative value, the more negative the value the more supinated. For a neutral foot the final score should lie somewhere around zero | week 8 | 
| Foot posture index | Pronated postures are given a positive value, the higher the value the more pronated. Supinated features are given a negative value, the more negative the value the more supinated. For a neutral foot the final score should lie somewhere around zero | week 12 | 
| Navicular Drop test | Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm) | baseline | 
| Navicular Drop test | Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm) | week 4 | 
| Navicular Drop test | Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm) | week 8 | 
| Navicular Drop test | Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm) | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postural control | three 10-seconds eyes opened trials and three 10-seconds eyes closed trials with single-leg stance | baseline | 
| Postural control | three 10-seconds eyes opened trials and three 10-seconds eyes closed trials with single-leg stance | week 4 | 
| Postural control | three 10-seconds eyes opened trials and three 10-seconds eyes closed trials with single-leg stance | week 8 | 
| Postural control | three 10-seconds eyes opened trials and three 10-seconds eyes closed trials with single-leg stance | week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Strengthening, training, intrinsic foot muscle