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

NCT05455645 | Unknown

• 1 other identifier: IFM exercise PF
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fasciitis, Chronic; Pain

Keywords

Strengthening; training; intrinsic foot muscle

Outcome Measures

Primary Outcomes (28)

• muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)

  ultrasound measurement

  baseline

• muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)

  ultrasound measurement

  week 4

• muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)

  ultrasound measurement

  week 8

• muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)

  ultrasound measurement

  week 12

• cross sectional area (CSA) 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

  week 4

• cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)

  ultrasound measurement

  week 8

• cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)

  ultrasound measurement

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  12

• Foot and Ankle Ability Measure (FAAM)

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

  baseline

• Foot and Ankle Ability Measure (FAAM)

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

  week 4

• Foot and Ankle Ability Measure (FAAM)

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

  week 8

• Foot and Ankle Ability Measure (FAAM)

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

  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

  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

  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

  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

  week 12

• Navicular Drop test

  Supinated foot (\<5mm); Neutral foot (5-9mm); pronated foot (\>9mm)

  baseline

• Navicular Drop test

  Supinated foot (\<5mm); Neutral foot (5-9mm); pronated foot (\>9mm)

  week 4

• Navicular Drop test

  Supinated foot (\<5mm); Neutral foot (5-9mm); pronated foot (\>9mm)

  week 8

• Navicular Drop test

  Supinated foot (\<5mm); Neutral foot (5-9mm); pronated foot (\>9mm)

  week 12

Secondary Outcomes (4)

• Postural control

  baseline

• Postural control

  week 4

• Postural control

  week 8

• Postural control

  week 12

Study Arms (2)

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.

Other: targeted intrinsic foot muscle exercises

Control

NO INTERVENTION

continue normal physical activity,

Interventions

targeted intrinsic foot muscle exercises OTHER

4 targeted intrinsic foot muscle exercises

Targeted intrinsic foot muscles exercise regimen

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

CUHK-ORT Sports Injury Research Laboratory

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Fasciitis, Plantar; Pain

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

On Yue LAU, PhD candidate

CONTACT

(852)64604033; fannielauoy@link.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Team members collecting outcomes data will not know participant allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial with one intervention arm and one control arm

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 13, 2022
• Study Start: August 30, 2022
• Primary Completion: March 30, 2023
• Study Completion: August 30, 2023
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)