Foot Core Stabilization Exercises Vs. Shockwave Therapy for Pain, Strength, and Function in Plantar Fasciitis

NCT06890806 | Active Not Recruiting

• 1 other identifier: E-10840098-202.3.02-7450
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness and feasibility of two distinct approache extracorporeal shock wave therapy and foot core stabilization exercises in the treatment of plantar faciitis (PF) by comparing their impacts on pain, muscle strength, and functionality. The study seeks to better understand the role of innovative exercise protocols in addressing biomechanical imbalances and the contribution of ESWT to biological healing mechanisms. The anticipated results are expected to provide evidence-based treatment approaches that can enhance the quality of life in individuals with PF, guide clinical applications in physical medicine and rehabilitation, and strengthen the position of these treatment methods within the broader healthcare system. Moreover, the findings may benefit a larger patient population by improving the management of PF.

Conditions

Plantar Fasciitis of Both Feet

Keywords

Extracorporeal Shock Wave Therapy; Pain; Foot stabilization exercises

Outcome Measures

Primary Outcomes (4)

• Pain

  The digital algometer is a pressure sensor used to measure pain thresholds by applying pressure to a specific point. In plantar fasciitis, it will assess foot sensitivity by measuring the pain threshold at the most painful area, especially the heel. Pressure is applied until pain is felt, and the recorded value indicates the threshold. The Visual Analog Scale (VAS) will evaluate heel pain by asking participants to mark their pain level on a 10 cm scale, where 0 means no pain and 10 signifies severe pain, based on their experience over the past week.

  through study completion, an average of 6 months.

• Medial longitudinal arc level

  The Navicular Drop Test will be used to assess participants' MLA height. Before measurements, the navicular tubercle will be marked while the individual stands barefoot. First, the distance between the navicular tubercle and the ground will be measured in millimeters while seated with the foot unloaded. Then, the individual will stand and bear full weight, and the new distance will be recorded. The difference between these two measurements will be calculated. Results will be classified as increased supination (\<5mm), neutral foot (5-9mm), and increased pronation (\>9mm).

  through study completion, an average of 6 months.

• Muscle strength

  The Kinvent K-Force digital device will be used for muscle strength measurement. Individuals with PF will lie in a supine position. For dorsiflexor strength measurement, the dynamometer will be placed on the upper metatarsal region, and for plantar flexors, it will be placed on the plantar metatarsal region. Participants will be asked to push against the dynamometer with maximum force, and the results will be recorded.

  through study completion, an average of 6 months.

• Quadriceps angle

  Changes in foot structure increase the Q angle, leading to genu valgum in the knee and pronation in the foot. Due to the tibia-talus relationship, foot pronation causes tibial internal rotation. Q angle measurement will be done using a plastic goniometer. Individuals with PF will lie supine with extended knees. The pivot point will be placed at the patella center. The movable arm will point to the anterior superior iliac spine, while the fixed arm will align with the tibial tuberosity. The angle between them will represent the Q angle

  through study completion, an average of 6 months.

Secondary Outcomes (2)

• Foot posture index

  through study completion, an average of 6 months.

• Foot function index

  through study completion, an average of 6 months.

Study Arms (2)

Foot Core Stabilization Exercise Group (FCSEG)

EXPERIMENTAL

Foot Core Stabilization Exercise Group (FCSEG)

Other: Foot Core Stabilization Exercise Group (FCSEG)

Extracorporeal Shock Wave Therapy Group (ESWTG)

EXPERIMENTAL

Extracorporeal Shock Wave Therapy Group (ESWTG)

Other: Extracorporeal Shock Wave Therapy Group (ESWTG)

Interventions

Foot Core Stabilization Exercise Group (FCSEG) OTHER

Exercise Group (Foot Core Stabilization Exercises) Exercise Group will perform foot core stabilization exercises under the supervision of a physiotherapist, three times a week for five weeks. The exercises will include: Short foot exercise Towel curl exercise Big toe press exercise Toe splay exercise Calf raise to big toe press exercise Leg swings Backward tandem walking Each exercise will be performed in three sets of 15 repetitions.

Foot Core Stabilization Exercise Group (FCSEG)

Extracorporeal Shock Wave Therapy Group (ESWTG) OTHER

Extracorporeal Shock Wave Therapy Group (ESWTG) One group will receive Extracorporeal Shock Wave Therapy (ESWT) once a week for five weeks. The ESWT sessions will be performed using the Gymna Shockmaster 500 device at a frequency of 15 Hz and a pressure of 3 bar, delivering a total of 1800 pulses per session.

Extracorporeal Shock Wave Therapy Group (ESWTG)

Eligibility Criteria

• Age: 25 Years - 60 Years
• Gender Eligibility Details: Only individuals who self-identify as female/male are eligible to participate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 25 to 60 years who have been diagnosed with plantar fasciitis by a physician specializing in physical medicine and rehabilitation or an orthopedic specialist.
• Heel pain localized to the medial calcaneal tubercle, persisting for three months or longer.
• Pain that worsens with the first steps taken in the morning or after periods of rest.

You may not qualify if:

• Individuals who have undergone foot or ankle surgery.
• Individuals with a history of chronic or active infection in the treatment area.
• Individuals with Type 1 or Type 2 Diabetes Mellitus, systemic inflammatory arthritis, cancer, active tuberculosis, or a history of neurological or vascular diseases.
• Individuals who have undergone conservative treatment including nonsteroidal anti-inflammatory drugs for 6 months with no significant improvement.
• Patients with numbness or tingling in the lower extremity, with or without provocation, or those with undiagnosed pain.
• Pregnancy.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Mudanya University

Bursa, Bursa, 16160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants were unaware of which group they would be assigned to. Based on the order of their arrival at the hospital, those who came in first, third, fifth, etc., were assigned to the Extracorporeal Shock Wave Therapy (ESWT) group, while those who came in second, fourth, sixth, etc., were assigned to the Stabilization Exercises group. This allocation method ensured that participants remained blinded to their group assignment, minimizing potential bias in their responses or expectations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: asisstant prof.

Model Details: The participants will be divided into two groups for treatment. One group will receive extracorporeal shock wave therapy (ESWT), while the other group will undergo stabilization exercises.

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 24, 2025
• Study Start: March 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

TU (1)