Plantar Fasciitis, ChronicNCT05455645
The Therapeutic Effect of Targeted Intrinsic Foot Muscles Exercises in Plantar Fasciitis
A study testing targeted intrinsic foot muscle exercises in people with Plantar Fasciitis, Chronic and Pain, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Plantar Fasciitis, Chronic, Pain
- What is being tested?
- targeted intrinsic foot muscle exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Aug 2022to 30 Aug 2023
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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, fannielauoy@link.cuhk.edu.hk
About this study
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.
Read the 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.
- Conditions
- Plantar Fasciitis, Chronic, Pain
- Being tested
- targeted intrinsic foot muscle exercises
- Keywords
- Strengthening, training, intrinsic foot muscle
- Medical subject headings
- Fasciitis, Plantar, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
targeted intrinsic foot muscle exercisesOther
4 targeted intrinsic foot muscle exercises
| Study group | Role | What they receive |
|---|---|---|
| Targeted intrinsic foot muscles exercise regimen | Experimental | 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. Receives: Other: targeted intrinsic foot muscle exercises |
| Control | No intervention | continue normal physical activity, |
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
muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
ultrasound measurement
Measured: week 4
muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
ultrasound measurement
Measured: week 8
muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
ultrasound measurement
Measured: week 12
cross sectional area (CSA) 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: week 4
cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
ultrasound measurement
Measured: week 8
cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
ultrasound measurement
Measured: 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)
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: 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)
Measured: 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)
Measured: 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)
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: 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)
Measured: 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)
Measured: 12
Foot and Ankle Ability Measure (FAAM)
Higher scores represent higher levels of function, with 100% representing no dysfunction.
Measured: baseline
Foot and Ankle Ability Measure (FAAM)
Higher scores represent higher levels of function, with 100% representing no dysfunction.
Measured: week 4
Foot and Ankle Ability Measure (FAAM)
Higher scores represent higher levels of function, with 100% representing no dysfunction.
Measured: week 8
Foot and Ankle Ability Measure (FAAM)
Higher scores represent higher levels of function, with 100% representing no dysfunction.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: week 12
Navicular Drop test
Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm)
Measured: baseline
Navicular Drop test
Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm)
Measured: week 4
Navicular Drop test
Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm)
Measured: week 8
Navicular Drop test
Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm)
Measured: week 12
Secondary outcomes (4)
Postural control
three 10-seconds eyes opened trials and three 10-seconds eyes closed trials with single-leg stance
Measured: baseline
Postural control
three 10-seconds eyes opened trials and three 10-seconds eyes closed trials with single-leg stance
Measured: week 4
Postural control
three 10-seconds eyes opened trials and three 10-seconds eyes closed trials with single-leg stance
Measured: week 8
Postural control
three 10-seconds eyes opened trials and three 10-seconds eyes closed trials with single-leg stance
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start30 Aug 2022 (estimated)
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar Fasciitis, ChronicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with one intervention arm and one control arm
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455645
- Sponsor's protocol ID
- IFM exercise PF
- Status last verified
- Jul 2022
- First submitted
- 7 Jul 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Effect of Targeted Intrinsic Foot Muscles Exercises in Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT05455645
- Acronym / sponsor ID
- IFM exercise PF
- Conditions
- Plantar Fasciitis, Chronic, Pain
- Keywords
- Strengthening, training, intrinsic foot muscle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 30 Aug 2022 (estimated)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 13 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial with one intervention arm and one control arm
| Arm | Type | Receives |
|---|---|---|
| Targeted intrinsic foot muscles exercise regimen | Experimental | Other: targeted intrinsic foot muscle exercises4 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. |
| Control | No intervention | –continue normal physical activity, |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (7 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| targeted intrinsic foot muscle exercises4 targeted intrinsic foot muscle exercises | Other | Targeted intrinsic foot muscles exercise regimen |
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
muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
Time frame: week 4
ultrasound measurement
muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
Time frame: week 8
ultrasound measurement
muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
Time frame: week 12
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
cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
Time frame: week 4
ultrasound measurement
cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
Time frame: week 8
ultrasound measurement
cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
Time frame: week 12
ultrasound measurement
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) pain at first steps in the morning
Time frame: week 4
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
Time frame: week 8
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
Time frame: week 12
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)
Visual Analog Scale (VAS) worst pain of the day
Time frame: 4
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: 8
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: 12
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 and Ankle Ability Measure (FAAM)
Time frame: week 4
Higher scores represent higher levels of function, with 100% representing no dysfunction.
Foot and Ankle Ability Measure (FAAM)
Time frame: week 8
Higher scores represent higher levels of function, with 100% representing no dysfunction.
Foot and Ankle Ability Measure (FAAM)
Time frame: week 12
Higher scores represent higher levels of function, with 100% representing no dysfunction.
Foot posture index
Time frame: baseline
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
Time frame: week 4
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
Time frame: week 8
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
Time frame: week 12
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
Time frame: baseline
Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm)
Navicular Drop test
Time frame: week 4
Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm)
Navicular Drop test
Time frame: week 8
Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm)
Navicular Drop test
Time frame: week 12
Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm)
4 secondary outcomes
Postural control
Time frame: baseline
Postural control
Time frame: week 4
Postural control
Time frame: week 8
Postural control
Time frame: week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing targeted intrinsic foot muscle exercises in people with Plantar Fasciitis, Chronic and Pain, 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 8 inclusion and 7 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 13 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 28 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 13 Jul 2022.