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

NCT ID: NCT05455645

Last Updated: 2022-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-30

Study Completion Date

2023-08-30

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.

Conditions

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Plantar Fasciitis, Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial with one intervention arm and one control arm
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Team members collecting outcomes data will not know participant allocation

Study Groups

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Targeted intrinsic foot muscles exercise regimen

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.

Group Type EXPERIMENTAL

targeted intrinsic foot muscle exercises

Intervention Type OTHER

4 targeted intrinsic foot muscle exercises

Control

continue normal physical activity,

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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targeted intrinsic foot muscle exercises

4 targeted intrinsic foot muscle exercises

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Lau On Yue

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CUHK-ORT Sports Injury Research Laboratory

Shatin, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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On Yue LAU, PhD candidate

Role: CONTACT

(852)64604033

Facility Contacts

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On Yue LAU, Phd candidate

Role: primary

Other Identifiers

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IFM exercise PF

Identifier Type: -

Identifier Source: org_study_id

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