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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05455645
• Other study ID #: IFM exercise PF
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: July 2022
• Source: Chinese University of Hong Kong
• Contact: On Yue LAU, PhD candidate
• Phone: (852)64604033
• Email: fannielauoy[@]link.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: August 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Pain
• Plantar Fasciitis, Chronic

Intervention

Other:
• targeted intrinsic foot muscle exercises
4 targeted intrinsic foot muscle exercises

Locations

Country	Name	City	State
Hong Kong	CUHK-ORT Sports Injury Research Laboratory	Sha Tin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)	ultrasound measurement	baseline
Primary	muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)	ultrasound measurement	week 4
Primary	muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)	ultrasound measurement	week 8
Primary	muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)	ultrasound measurement	week 12
Primary	cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)	ultrasound measurement	Baseline
Primary	cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)	ultrasound measurement	week 4
Primary	cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)	ultrasound measurement	week 8
Primary	cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)	ultrasound measurement	week 12
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Foot and Ankle Ability Measure (FAAM)	Higher scores represent higher levels of function, with 100% representing no dysfunction.	baseline
Primary	Foot and Ankle Ability Measure (FAAM)	Higher scores represent higher levels of function, with 100% representing no dysfunction.	week 4
Primary	Foot and Ankle Ability Measure (FAAM)	Higher scores represent higher levels of function, with 100% representing no dysfunction.	week 8
Primary	Foot and Ankle Ability Measure (FAAM)	Higher scores represent higher levels of function, with 100% representing no dysfunction.	week 12
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Navicular Drop test	Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm)	baseline
Primary	Navicular Drop test	Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm)	week 4
Primary	Navicular Drop test	Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm)	week 8
Primary	Navicular Drop test	Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm)	week 12
Secondary	Postural control	three 10-seconds eyes opened trials and three 10-seconds eyes closed trials with single-leg stance	baseline
Secondary	Postural control	three 10-seconds eyes opened trials and three 10-seconds eyes closed trials with single-leg stance	week 4
Secondary	Postural control	three 10-seconds eyes opened trials and three 10-seconds eyes closed trials with single-leg stance	week 8
Secondary	Postural control	three 10-seconds eyes opened trials and three 10-seconds eyes closed trials with single-leg stance	week 12