Clinical trial NCT06890806: Foot Core Stabilization Exercises Vs. Shockwave Therapy for Pain, Strength, and Function in Plantar Fasciitis
Official title: Comparison of the Effects of Foot Core Stabilization Exercises Versus Extracorporeal Shock Wave Therapy (ESWT) on Pain, Muscle Strength and Functionality in Individuals with Plantar Fasciitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Plantar Fasciitis of Both Feet
Keywords: Extracorporeal Shock Wave Therapy
Pain
Foot stabilization exercises
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Participants aged 25-60 years who applied to the Physical Medicine and Rehabilitation Department of Bursa VM Medical Park Hospital and were diagnosed with plantar fasciitis (PF) by a physical medicine and rehabilitation physician or orthopedist will be included in the study. A total of 40 participants will be randomized, with 20 individuals in each group. Randomization will be based on the order of participant enrollment. The groups will be named the Foot Core Stabilization Exercise Group (ACSEG) and the Extracorporeal Shock Wave Therapy Group (ESWTG).

Informed consent forms will be obtained from individuals who meet the inclusion criteria. After collecting sociodemographic information, the following assessment methods will be applied, and the results will be recorded in the pre- and post-treatment evaluation form.

Evaluation:

After collecting sociodemographic information, participants' pain will be assessed using the Visual Analog Scale (VAS), medial longitudinal arch (MLA) height will be evaluated using the Navicular Drop Test, muscle strength will be measured using the Kinvent K-Force device, the relationship between foot structure and lower extremity biomechanics will be assessed using the Quadriceps (Q) Angle measured with a goniometer, foot posture will be evaluated using the Foot Posture Index (FPI), and foot function will be assessed using the Foot Function Index (FFI). All evaluations will be conducted under the supervision of an expert physiotherapist.

Sociodemographic Information:

The names, ages, heights, weights, body mass indices (BMI), and occupations of the participants with PF will be recorded.

Visual Analog Scale (VAS):

The VAS will be used to assess heel pain in individuals with PF. Participants will mark their pain on a 10 cm scale, where 0 represents no pain and 10 represents severe pain.

Navicular Drop Test:

The Navicular Drop Test will be used to evaluate MLA height. The navicular tubercle will be marked with a pen while the participant stands barefoot. The distance between the navicular tubercle and the ground will be measured in millimeters (mm) while the participant is seated without bearing weight on the foot. The participant will then stand and bear full weight on the foot, and the distance will be measured again. The difference between the two measurements will be recorded. Results will be classified as increased supination (\<5 mm), neutral foot (5-9 mm), or increased pronation (\>9 mm).

Muscle Strength Measurement:

Muscle strength will be measured using the Kinvent K-Force device. Participants will lie supine, and the dynamometer will be placed on the upper metatarsal region for dorsiflexor strength and the plantar metatarsal region for plantar flexor strength. Participants will push against the dynamometer with maximum force, and the results will be recorded.

Quadriceps (Q) Angle Measurement:

The Q angle will be measured using a plastic goniometer. Participants will lie supine with their knees extended. The goniometer's pivot point will be placed at the midpoint of the patella, with the movable arm pointing to the anterior superior iliac spine and the fixed arm aligned with the tibial tuberosity. The angle between the two arms will be recorded as the Q angle.

Foot Posture Index (FPI):

Foot posture will be assessed using the Foot Posture Index. Participants will stand in a relaxed position, looking forward, with arms at their sides and maintaining proper body alignment. Six clinical criteria will be evaluated:

Palpation of the talar head. Curves above and below the lateral malleolus. Inversion/eversion of the calcaneus. Bulging in the talonavicular joint region. Structure of the MLA. Forefoot abduction/adduction relative to the hindfoot. Each criterion will be scored from -2 to +2, with the total score recorded. A score of 0 indicates a neutral foot, positive values indicate pronation, and negative values indicate supination.

Foot Function Index (FFI):

The FFI evaluates foot pain, disability, and activity limitations through 23 items divided into three subscales. The pain subscale measures the level of foot pain in various situations, the disability subscale assesses the difficulty of performing functional activities due to foot problems, and the activity limitation subscale evaluates restrictions caused by foot problems. Participants will score each item based on their foot condition over the past week using the VAS.

Treatment:

The Foot Core Stabilization Exercise Group (ACSEG) will receive foot core stabilization exercises, while the Extracorporeal Shock Wave Therapy Group (ESWTG) will undergo shock wave therapy.

Extracorporeal Shock Wave Therapy Group (ESWTG):

ESWT will be administered using the Gymna Shockmaster 500 device by an expert physiotherapist. The therapy will be applied in continuous mode at 15 Hz frequency, with a pressure of 3 bars, delivering 1800 pulses per session. Treatment will be administered once a week for five weeks. After identifying the painful area on the heel, 200 pulses will be applied to each of the nine points, totaling 1800 pulses.

Foot Core Stabilization Exercise Group (ACSEG):

Participants will perform foot core stabilization exercises under the supervision of an expert physiotherapist for 40 minutes, three times a week, for five weeks.

Short Foot Exercise: Participants will sit with hips, knees, and ankles at 90 degrees, feet flat on the floor. They will pull their toes toward the heel to elevate the medial longitudinal arch, hold for 5 seconds, and relax. This will be repeated 15 times.

Towel Curl Exercise: Participants will sit with hips, knees, and ankles at 90 degrees, feet flat on the floor, with a towel placed under their feet. They will use their toes to gather the towel and then flatten it. This will be repeated 15 times.

Big Toe Press Exercise: Participants will press the big toe to the ground while lifting the other four toes, hold for 5 seconds, and repeat 15 times.

Toe Splay Exercise: Participants will sit with hips, knees, and ankles at 90 degrees, feet flat on the floor. They will spread the big toe and other toes apart, hold for 5 seconds, and repeat 15 times.

Calf Raise to Big Toe Press Exercise: Participants will stand barefoot on the edge of a step, lower their heels below the step level, rise onto their toes, and press onto the big toe, holding for 5 seconds. This will be repeated 15 times.

Leg Swings Exercise: Participants will stand barefoot on the affected foot, pulling the toes toward the heel to create an arch. The other leg will swing forward, backward, and side-to-side in small ranges of motion 15 times each.

Backward Tandem Walk Exercise: Participants will walk backward in a straight line, placing the heel of one foot directly in front of the toes of the other foot without deviating from the line.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pain
timeFrame: through study completion, an average of 6 months.
measure: Medial longitudinal arc level
timeFrame: through study completion, an average of 6 months.
measure: Muscle strength
timeFrame: through study completion, an average of 6 months.
measure: Quadriceps angle
timeFrame: through study completion, an average of 6 months.
Secondary outcomes:
measure: Foot posture index
timeFrame: through study completion, an average of 6 months.
measure: Foot function index
timeFrame: through study completion, an average of 6 months.
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Mudanya University
Study officials:
References: