NCT05462002

Brief Summary

Plantar fasciitis is one of the most common musculoskeletal conditions in distance runners. 44% of patients still had the symptoms after 15 years from the first onset. The chronicity of the condition may lead to significant limitations on daily activities and even cessation of running. In the concept of foot core system, the intrinsic foot muscles work together with plantar fascia to stabilize the foot arches and provide dynamic support to the foot during functional activities. Given that the intrinsic foot muscles also play an important role as a direct sensors of foot deformation, postural control may be compromised during pathological state. Therefore, this study aim to investigate the differences in the muscle thickness and cross-sectional area of intrinsic foot muscles and postural control in runners with and without plantar fasciitis. We hypothesized that runners with plantar fasciitis demonstrate small intrinsic foot muscles sizes and poor postural control when compared with the asymptomatic counterparts.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

1 year

First QC Date

July 8, 2022

Last Update Submit

July 13, 2022

Conditions

Keywords

intrinsic foot muscle, plantar fasciitis, runners, balance, postural control

Outcome Measures

Primary Outcomes (7)

  • Muscle thickness (MT) 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

    baseline

  • postural control

    three 10-seconds eyes opened trials and three 10-seconds eyes closed trials single-leg stance recorded on an instrumented force platform. percent modulation was calculated using equation 1 to provide an estimate of a participant's reliance on visual information for the postural control of intrinsic foot muscles. Equation 1 is as followed. % modulation= (eyes open velocity-eyes closed velocity)/(eyes open velocity) Larger negative values represent a greater impairment to postural control when vision is removed and suggest a greater reliance on visual information.

    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)

    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)

    baseline

  • Foot and Ankle Ability Measure (FAAM)

    Higher scores represent higher levels of function, with 100% representing no dysfunction.

    baseline

  • Foot Function Index revised short form (FFI-RS)

    grade 1 corresponds to no pain and 4 corresponds to worst pain imaginable. The numerical 5 is not used as a score but is used to indicate that the subscale question is not applicable for the participant. Higher scores represent higher levels of pain, stiffness, difficulty, activity limitation, and psychosocial aspect

    baseline

Secondary Outcomes (2)

  • Foot posture index (FPI)

    Baseline

  • Navicular drop

    Baseline

Study Arms (2)

plantar fasciitis group

Distance runners with plantar fasciitis

asymptomatic control group

Distance runners without plantar fasciitis

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

distance runners who run more than 20km per week for at least 2 years.

You may qualify if:

  • distance runners who run more than 20km per week for at least 2 years. Runners who were between 18 and 60 years of age with symptoms of chronic plantar fasciitis: if they reported tenderness on palpation of the medial calcaneal tuberosity, thickness of plantar fascia \>4.0mm at insertion with USG, and exhibited one of the following complaints: 1. plantar heel pain \> 1 month; 2 pain on the first step in the morning or after prolonged sitting; 3. pain on prolonged standing; 4 pain when running.

You may not qualify if:

  • Those who had undergone surgery to the plantar fascia, or had local injection within the last 3 months, or had any coexisting painful musculoskeletal condition of the lower limb, or any neurological or systematic disease were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CUHK-ORT Sports Injury Research Laboratory

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Study Officials

  • On Yue Lau, PhD candidate

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

On Yue LAU, PhD candidate

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 8, 2022

First Posted

July 18, 2022

Study Start

November 1, 2021

Primary Completion

November 1, 2022

Study Completion

June 1, 2023

Last Updated

July 18, 2022

Record last verified: 2022-07

Locations