Plantar FascitisNCT05462002
Intrinsic Foot Muscle Morphology and Function in Runners With and Without Plantar Fasciitis
An observational study of Plantar Fascitis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Plantar Fascitis
- How many people
- 64 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2021to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
Study population: distance runners who run more than 20km per week for at least 2 years.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
CUHK-ORT Sports Injury Research Laboratory
Shatin
On Yue LAU, Phd candidate, (852) 64604033, fannielauoy@link.cuhk.edu.hk
About this study
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.
Read the detailed description
this is a case-control study, using ultrasound imaging (USG) to examine the differences in muscle thickness (MT) and cross-sectional area (CSA) of Abductor Hallucis (AbH), flexor hallucis brevis (FHB), flexor digitorum brevis (FDB), and quadratus plantae (QP), and postural control in runners with and without plantar fasciitis. All participants were recruited through recruitment flyers and word of mouth from local running community. The dependent variables included navicular height using navicular drop test, foot posture using the 6-item Foot Posture Index (FPI-6). The actual status of symptoms was evaluated by visual analog scale (VAS) pain at the first steps in the morning, VAS pain at worst of the day, the Foot Function Index Revised short form (FFI-R S), and the Foot and Ankle Ability Measure (FAAM).
The postural control was assessed by three 10-seconds eyes opened trials and three 10-seconds eyes closed trials single-leg stance recorded on an instrumented force platform . (AMTI. Watertown, MA) at 50 Hz. Center of pressure velocity (cm/s) was calculated for each condition using Balance Clinic software (AMTI. Watertown, MA). In addition, 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.
- Conditions
- Plantar Fascitis
- Keywords
- intrinsic foot muscle, plantar fasciitis, runners, balance, postural control
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| plantar fasciitis group | Distance runners with plantar fasciitis | |
| asymptomatic control group | Distance runners without plantar fasciitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle thickness (MT) of Abductor Hallucis (AbH), Flexor Hallucis Brevis (FHB), Flexor Digitorum Brevis (FDB), Quadratus Plantae (QP)
ultrasound measurement
Measured: baseline
Cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor Hallucis Brevis (FHB), Flexor Digitorum Brevis (FDB), Quadratus Plantae (QP)
ultrasound measurement
Measured: 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.
Measured: 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)
Measured: 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)
Measured: baseline
Foot and Ankle Ability Measure (FAAM)
Higher scores represent higher levels of function, with 100% representing no dysfunction.
Measured: 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
Measured: baseline
Secondary outcomes (2)
Foot posture index (FPI)
Pronated postures are given a positive value, the higher the value the more pronated.
Measured: Baseline
Navicular drop
Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 Nov 2021
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lau On Yue, Chinese University of Hong Kong
- Investigators
- On Yue Lau, PhD candidate, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462002
- Sponsor's protocol ID
- PF_IFM_Training
- Status last verified
- Jul 2022
- First submitted
- 8 Jul 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrinsic Foot Muscle Morphology and Function in Runners With and Without Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT05462002
- Acronym / sponsor ID
- PF_IFM_Training
- Conditions
- Plantar Fascitis
- Keywords
- intrinsic foot muscle, plantar fasciitis, runners, balance, postural control
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
this is a case-control study, using ultrasound imaging (USG) to examine the differences in muscle thickness (MT) and cross-sectional area (CSA) of Abductor Hallucis (AbH), flexor hallucis brevis (FHB), flexor digitorum brevis (FDB), and quadratus plantae (QP), and postural control in runners with and without plantar fasciitis. All participants were recruited through recruitment flyers and word of mouth from local running community. The dependent variables included navicular height using navicular drop test, foot posture using the 6-item Foot Posture Index (FPI-6). The actual status of symptoms was evaluated by visual analog scale (VAS) pain at the first steps in the morning, VAS pain at worst of the day, the Foot Function Index Revised short form (FFI-R S), and the Foot and Ankle Ability Measure (FAAM).
The postural control was assessed by three 10-seconds eyes opened trials and three 10-seconds eyes closed trials single-leg stance recorded on an instrumented force platform . (AMTI. Watertown, MA) at 50 Hz. Center of pressure velocity (cm/s) was calculated for each condition using Balance Clinic software (AMTI. Watertown, MA). In addition, 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| plantar fasciitis group | – | –Distance runners with plantar fasciitis |
| asymptomatic control group | – | –Distance runners without plantar fasciitis |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- distance runners who run more than 20km per week for at least 2 years.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Muscle thickness (MT) of Abductor Hallucis (AbH), Flexor Hallucis Brevis (FHB), Flexor Digitorum Brevis (FDB), Quadratus Plantae (QP)
Time frame: baseline
ultrasound measurement
Cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor Hallucis Brevis (FHB), Flexor Digitorum Brevis (FDB), Quadratus Plantae (QP)
Time frame: baseline
ultrasound measurement
postural control
Time frame: baseline
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.
Visual Analog Scale (VAS) pain at first steps in the morning
Time frame: baseline
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
Time frame: baseline
measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain)
Foot and Ankle Ability Measure (FAAM)
Time frame: baseline
Higher scores represent higher levels of function, with 100% representing no dysfunction.
Foot Function Index revised short form (FFI-RS)
Time frame: baseline
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
2 secondary outcomes
Foot posture index (FPI)
Time frame: Baseline
Navicular drop
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
On Yue Lau, PhD candidate principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plantar Fascitis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact On Yue LAU, PhD candidate ((852)64604033, fannielauoy@link.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle thickness (MT) of Abductor Hallucis (AbH), Flexor Hallucis Brevis (FHB), Flexor Digitorum Brevis (FDB), Quadratus Plantae (QP) (time frame: baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.