Observation on the Efficacy of Improving Ankle Dorsiflexion Limitation in Patients With Plantar Fasciitis

NCT06542211 | Recruiting

• 1 other identifier: M2023360
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to design a randomized controlled trial to treat plantar fasciitis by combining conventional rehabilitation with the improvement of ankle dorsiflexion function, and to explore its clinical efficacy by combining various evaluation indicators. Compared with conventional plantar fasciitis, ankle dorsiflexion function rehabilitation training focuses more on the improvement of patients\' foot and ankle function. Conventional PF rehabilitation training focuses on loosening the plantar fascia and gastrocnemius muscle, which can restore the elasticity of the plantar fascia and promote pain relief, but has limited improvement in ankle dorsiflexion function, resulting in patients\' daily life such as walking, squatting, and going upstairs. Ankle dorsiflexion function rehabilitation training is an intervention directly targeting the function of the foot and ankle joint. By restoring the ankle dorsiflexion function of patients, it helps patients correct the force line in daily life movements, reduce the probability of sports injury risk, and improve sports performance and daily life satisfaction. Conventional rehabilitation for plantar fasciitis mainly focuses on relaxing the plantar fascia, gastrocnemius muscle, and plantar flexor muscle strength and strengthening the small muscle group exercises of the plantar foot. The experimental group directly intervened and conducted rehabilitation training for the limited ankle dorsiflexion function. It mainly includes subtalar joint loosening (increasing joint activity space), plantar flexor muscle group relaxation (releasing antagonist muscle tension), ankle dorsiflexor muscle strengthening (enhancing agonist muscle strength), and integrated exercises (integrating ankle dorsiflexion function into gait training). This experiment lasted for a total of eight weeks, and patients were required to complete five home rehabilitation training sessions per week.

Conditions

Plantar Fasciitis

Keywords

ankle dorisflexion; plantar fasciitis

Outcome Measures

Primary Outcomes (3)

• Vicon 3D gait test

  The subjects wore sports shorts, fully exposing the waist and the area below the mid-thigh. After the reflective markers were fixed, the subjects first familiarized themselves with the requirements and process of collecting movements according to the test procedures. The subjects stood in the center of the test room, with their feet shoulder-width apart and their upper limbs naturally placed on both sides of the body. They kept the subtalar joint in a neutral position and conducted three static tests to collect static data for defining the coordinate system of the bone segments. Afterwards, the subjects performed walking and jogging tests at the speed they felt most comfortable. The interval between the two tests was based on the patient not feeling tired. 5 valid data were collected for each action, and the average value of the 5 tests was used for analysis.

  40min

• Plantar fascia thickness measurement

  The Japanese KONICA MINOLTA musculoskeletal ultrasound was used for testing, with a probe frequency of 3 to 18 Hz. Experienced clinicians were selected to perform the measurements. The patients were placed in a prone position with their ankle joints in a neutral position. The calcaneus and plantar fascia junction were measured. The doctor measured the plantar fascia thickness on the affected side of the patient, and the average value of three ultrasound measurement images was selected each time.

  20min

• Ankle dorsiflexion angle measurement

  Ankle dorsiflexion angle in supine straight knee position and in lunge with bent knee position

  10min

Secondary Outcomes (3)

• Ankle and hindfoot function rating scale

  10min

• Visual Analogue Scale for Pain

  20min

• Plantar pressure test

  20min

Study Arms (2)

Plantar Fasciitis Test Group

EXPERIMENTAL

The experimental group received intervention and rehabilitation training directly for the limited ankle dorsiflexion function, which mainly included subtalar joint loosening (increasing the joint activity space), plantar flexor muscle group relaxation (releasing the tension of antagonist muscles), ankle dorsiflexor muscle strengthening (enhancing the strength of agonist muscles), and integrated exercises (integrating ankle dorsiflexion function into gait training).

Behavioral: Intervention plan for improving ankle dorsiflexion limitation group (experimental group)

Plantar fasciitis conventional rehabilitation group

ACTIVE COMPARATOR

Conventional rehabilitation for plantar fasciitis mainly focuses on relaxing the plantar fascia, gastrocnemius and plantar flexor muscles and strengthening the small muscle groups of the plantar foot.

Behavioral: Plantar fasciitis routine rehabilitation group

Interventions

Intervention plan for improving ankle dorsiflexion limitation group (experimental group) BEHAVIORAL

The experimental group received intervention and rehabilitation training directly for the limited ankle dorsiflexion function, which mainly included subtalar joint loosening (increasing the joint activity space), plantar flexor muscle group relaxation (releasing the tension of antagonist muscles), ankle dorsiflexor muscle strengthening (enhancing the strength of agonist muscles), and integrated exercises (integrating ankle dorsiflexion function into gait training).

Plantar Fasciitis Test Group

Plantar fasciitis routine rehabilitation group BEHAVIORAL

The experimental group received intervention and rehabilitation training directly for the limited ankle dorsiflexion function, which mainly included subtalar joint loosening (increasing the joint activity space), plantar flexor muscle group relaxation (releasing the tension of antagonist muscles), ankle dorsiflexor muscle strengthening (enhancing the strength of agonist muscles), and integrated exercises (integrating ankle dorsiflexion function into gait training).

Plantar fasciitis conventional rehabilitation group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age range: 30-60 years old; disease course \> 3 months; pain cannot be relieved by conservative treatment such as rest, oral nonsteroidal drugs, and physical therapy; VAS score is less than 6 points.
• According to the clinical practice guidelines of the International Classification of Functioning, Disability and Health: Heel Pain/Plantar Fasciitis: 2014 Revision \[16\], patients meet the clinical diagnostic criteria for PF, mainly including pain on the medial side of the plantar, heel pain caused by recent weight-bearing activities, pain on palpation of the proximal attachment of the plantar fascia, and positive Windlass test;
• Supine straight knee ankle dorsiflexion angle \<10°; lunge knee flexion \<40° \[50, 51\]; left and right foot dorsiflexion difference does not exceed 1°.
• BMI between 18.5-23.9 (Chinese standard)

You may not qualify if:

• \- (1) Those who have received local injections of steroids in the past 3 months; (2) Those with other foot, ankle and lower leg diseases: history of surgery, fracture, trauma, plantar skin ulcers, rheumatism or rheumatoid arthritis, etc.; (3) Those with serious medical diseases: such as blood diseases, coagulopathy, severe cardiovascular and cerebrovascular dysfunction, tumor diseases, etc.
• (4) Those with peripheral neuropathy (idiopathic, diabetic, nutritional); L5/S1 neural foramen impingement or lumbar spinal stenosis (5) Congenital structural flat feet, equinus deformity or other foot and ankle joint diseases

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Central Study Contacts

Hongshi Huang

CONTACT

13910093298; huanghs@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2024
• First Posted: August 7, 2024
• Study Start: May 20, 2024
• Primary Completion: March 2, 2025
• Study Completion: March 2, 2025
• Last Updated: August 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)