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

Primary Purpose

Plantar Fasciitis, Chronic, Pain

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
targeted intrinsic foot muscle exercises
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis, Chronic focused on measuring Strengthening, training, intrinsic foot muscle

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. A weekly mileage of at least 20km
  2. Have running experience of at least 2 years prior to the experiment

  3. 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:

  1. Contraindications to MRI scans
  2. had undergone surgery to the plantar fascia or
  3. local steroid injection within the last 3 months or

  4. Any of the following conditions:

    • systemic arthritis,
    • neurologic conditions
    • any coexisting painful musculoskeletal condition of the lower limb.

Sites / Locations

  • CUHK-ORT Sports Injury Research LaboratoryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Targeted intrinsic foot muscles exercise regimen

Control

Arm Description

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.

continue normal physical activity,

Outcomes

Primary Outcome Measures

muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
ultrasound measurement
muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
ultrasound measurement
muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
ultrasound measurement
muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
ultrasound measurement
cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
ultrasound measurement
cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
ultrasound measurement
cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
ultrasound measurement
cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
ultrasound measurement
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)
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)
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)
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)
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)
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)
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)
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)
Foot and Ankle Ability Measure (FAAM)
Higher scores represent higher levels of function, with 100% representing no dysfunction.
Foot and Ankle Ability Measure (FAAM)
Higher scores represent higher levels of function, with 100% representing no dysfunction.
Foot and Ankle Ability Measure (FAAM)
Higher scores represent higher levels of function, with 100% representing no dysfunction.
Foot and Ankle Ability Measure (FAAM)
Higher scores represent higher levels of function, with 100% representing no dysfunction.
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
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
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
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
Navicular Drop test
Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm)
Navicular Drop test
Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm)
Navicular Drop test
Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm)
Navicular Drop test
Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm)

Secondary Outcome Measures

Postural control
three 10-seconds eyes opened trials and three 10-seconds eyes closed trials with single-leg stance
Postural control
three 10-seconds eyes opened trials and three 10-seconds eyes closed trials with single-leg stance
Postural control
three 10-seconds eyes opened trials and three 10-seconds eyes closed trials with single-leg stance
Postural control
three 10-seconds eyes opened trials and three 10-seconds eyes closed trials with single-leg stance

Full Information

First Posted
July 7, 2022
Last Updated
July 8, 2022
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05455645
Brief Title
The Therapeutic Effect of Targeted Intrinsic Foot Muscles Exercises in Plantar Fasciitis
Official Title
The Therapeutic Effect of Targeted Intrinsic Foot Muscles Exercises in Plantar Fasciitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2022 (Anticipated)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis, Chronic, Pain
Keywords
Strengthening, training, intrinsic foot muscle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with one intervention arm and one control arm
Masking
ParticipantOutcomes Assessor
Masking Description
Team members collecting outcomes data will not know participant allocation
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Targeted intrinsic foot muscles exercise regimen
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
continue normal physical activity,
Intervention Type
Other
Intervention Name(s)
targeted intrinsic foot muscle exercises
Intervention Description
4 targeted intrinsic foot muscle exercises
Primary Outcome Measure Information:
Title
muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
Description
ultrasound measurement
Time Frame
baseline
Title
muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
Description
ultrasound measurement
Time Frame
week 4
Title
muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
Description
ultrasound measurement
Time Frame
week 8
Title
muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
Description
ultrasound measurement
Time Frame
week 12
Title
cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
Description
ultrasound measurement
Time Frame
Baseline
Title
cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
Description
ultrasound measurement
Time Frame
week 4
Title
cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
Description
ultrasound measurement
Time Frame
week 8
Title
cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
Description
ultrasound measurement
Time Frame
week 12
Title
Visual Analog Scale (VAS) pain at first steps in the morning
Description
measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain)
Time Frame
baseline
Title
Visual Analog Scale (VAS) pain at first steps in the morning
Description
measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain)
Time Frame
week 4
Title
Visual Analog Scale (VAS) pain at first steps in the morning
Description
measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain)
Time Frame
week 8
Title
Visual Analog Scale (VAS) pain at first steps in the morning
Description
measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain)
Time Frame
week 12
Title
Visual Analog Scale (VAS) worst pain of the day
Description
measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain)
Time Frame
baseline
Title
Visual Analog Scale (VAS) worst pain of the day
Description
measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain)
Time Frame
4
Title
Visual Analog Scale (VAS) worst pain of the day
Description
measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain)
Time Frame
8
Title
Visual Analog Scale (VAS) worst pain of the day
Description
measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain)
Time Frame
12
Title
Foot and Ankle Ability Measure (FAAM)
Description
Higher scores represent higher levels of function, with 100% representing no dysfunction.
Time Frame
baseline
Title
Foot and Ankle Ability Measure (FAAM)
Description
Higher scores represent higher levels of function, with 100% representing no dysfunction.
Time Frame
week 4
Title
Foot and Ankle Ability Measure (FAAM)
Description
Higher scores represent higher levels of function, with 100% representing no dysfunction.
Time Frame
week 8
Title
Foot and Ankle Ability Measure (FAAM)
Description
Higher scores represent higher levels of function, with 100% representing no dysfunction.
Time Frame
week 12
Title
Foot posture index
Description
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
Time Frame
baseline
Title
Foot posture index
Description
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
Time Frame
week 4
Title
Foot posture index
Description
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
Time Frame
week 8
Title
Foot posture index
Description
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
Time Frame
week 12
Title
Navicular Drop test
Description
Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm)
Time Frame
baseline
Title
Navicular Drop test
Description
Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm)
Time Frame
week 4
Title
Navicular Drop test
Description
Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm)
Time Frame
week 8
Title
Navicular Drop test
Description
Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm)
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Postural control
Description
three 10-seconds eyes opened trials and three 10-seconds eyes closed trials with single-leg stance
Time Frame
baseline
Title
Postural control
Description
three 10-seconds eyes opened trials and three 10-seconds eyes closed trials with single-leg stance
Time Frame
week 4
Title
Postural control
Description
three 10-seconds eyes opened trials and three 10-seconds eyes closed trials with single-leg stance
Time Frame
week 8
Title
Postural control
Description
three 10-seconds eyes opened trials and three 10-seconds eyes closed trials with single-leg stance
Time Frame
week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
On Yue LAU, PhD candidate
Phone
(852)64604033
Email
fannielauoy@link.cuhk.edu.hk
Facility Information:
Facility Name
CUHK-ORT Sports Injury Research Laboratory
City
Sha Tin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
On Yue LAU, Phd candidate
Email
fannielauoy@link.cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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