Clinical trial NCT05455645: The Therapeutic Effect of Targeted Intrinsic Foot Muscles Exercises in Plantar Fasciitis
Official title: The Therapeutic Effect of Targeted Intrinsic Foot Muscles Exercises in Plantar Fasciitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plantar Fasciitis, Chronic
Pain
Keywords: Strengthening
training
intrinsic foot muscle
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with one intervention arm and one control arm
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
timeFrame: baseline
measure: muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
timeFrame: week 4
measure: muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
timeFrame: week 8
measure: muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
timeFrame: week 12
measure: cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
timeFrame: Baseline
measure: cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
timeFrame: week 4
measure: cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
timeFrame: week 8
measure: cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)
timeFrame: week 12
measure: Visual Analog Scale (VAS) pain at first steps in the morning
timeFrame: baseline
measure: Visual Analog Scale (VAS) pain at first steps in the morning
timeFrame: week 4
measure: Visual Analog Scale (VAS) pain at first steps in the morning
timeFrame: week 8
measure: Visual Analog Scale (VAS) pain at first steps in the morning
timeFrame: week 12
measure: Visual Analog Scale (VAS) worst pain of the day
timeFrame: baseline
measure: Visual Analog Scale (VAS) worst pain of the day
timeFrame: 4
measure: Visual Analog Scale (VAS) worst pain of the day
timeFrame: 8
measure: Visual Analog Scale (VAS) worst pain of the day
timeFrame: 12
measure: Foot and Ankle Ability Measure (FAAM)
timeFrame: baseline
measure: Foot and Ankle Ability Measure (FAAM)
timeFrame: week 4
measure: Foot and Ankle Ability Measure (FAAM)
timeFrame: week 8
measure: Foot and Ankle Ability Measure (FAAM)
timeFrame: week 12
measure: Foot posture index
timeFrame: baseline
measure: Foot posture index
timeFrame: week 4
measure: Foot posture index
timeFrame: week 8
measure: Foot posture index
timeFrame: week 12
measure: Navicular Drop test
timeFrame: baseline
measure: Navicular Drop test
timeFrame: week 4
measure: Navicular Drop test
timeFrame: week 8
measure: Navicular Drop test
timeFrame: week 12
Secondary outcomes:
measure: Postural control
timeFrame: baseline
measure: Postural control
timeFrame: week 4
measure: Postural control
timeFrame: week 8
measure: Postural control
timeFrame: week 12
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: CUHK-ORT Sports Injury Research Laboratory
Study officials:
References: