Sultan Abdulhamid Han Training and Research Hospital
Istanbul, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07640620
Plantar fasciitis is a common cause of heel pain and is traditionally considered a mechanical musculoskeletal disorder. Recent evidence suggests that central sensitization may also contribute to pain in individuals with plantar fasciitis. This study aims to investigate the relationships between neurophysiological variables (pressure pain threshold, central sensitization, and pain intensity), psychological factors (pain catastrophizing, kinesiophobia, anxiety, and depression), ultrasonographic findings (plantar fascia thickness), and functional outcomes (foot function and quality of life) in patients with plantar fasciitis.
Interested in participating?
Request Info18 year–65 year
All sexes
Observational
Istanbul, Turkey (Türkiye)
Location status: Recruiting
Heel pain caused by plantar fasciitis is one of the common reasons for visits to Physical Medicine and Rehabilitation outpatient clinics. Plantar fasciitis is characterized by throbbing medial plantar heel pain that occurs especially with the first step in the morning or after long periods of rest and is a musculoskeletal disorder. The diagnosis of plantar fasciitis is usually determined clinically. In ultrasound, findings such as thickening of the plantar fascia and hypoechogenicity in the fascia are advantageous in diagnosis. Although the mechanical aspect of pain has often been emphasized in the treatment of plantar fasciitis, recent studies have gained momentum in suggesting that central sensitization is also among the pain mechanisms of plantar fasciitis. In addition, as with many chronic musculoskeletal pains, the role of psychological factors such as kinesiophobia, catastrophizing pain, depressive symptoms, and anxiety has been investigated in plantar fasciitis. However, data on the relationship between factors such as pressure pain sensitivity, central sensitization, catastrophizing pain, and kinesiophobia in plantar fasciitis are limited. The aim of this study is to contribute to the increasing literature in this field by investigating the relationship between psychological (catastrophizing pain, kinesiophobia, anxiety, and depression), ultrasonographic findings (plantar fascia thickness), and functional status (foot functional index, quality of life) variables with neurophysiological (pressure pain threshold, central sensitization, pain) variables in plantar fasciitis.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Plantar Fasciitis Group
Healthy Control
Pressure pain threshold measurements will be performed using a pressure algometer to assess pain sensitivity.
Ultrasonographic evaluation will be performed to measure plantar fascia thickness and assess plantar fascia morphology.
Time frame: Baseline
Pressure pain threshold is defined as the minimal pressure level that causes pain. The measurement will be applied twice for each region with a 1-minute interval, and the average of these applications will be recorded. A trial test will be conducted on the patient before the actual test. Pressure will be applied to selected points with a pressure algometer until pain is induced, and the test for that area will be terminated when the patient feels pain.
The measurement will be taken from the calcaneus bone (the starting point of the plantar fascia) and from the forearm, which is a distant, painless, and unrelated area, using the Wagner manual pressure algometer (1 cm² probe-10 kg/20 lb). The reliability of the measurement in these areas has been demonstrated.
Time frame: Baseline
Pain severity will be evaluated using a scale rated from 0 (no pain) to 10 (unbearable pain). Participants will be asked to rate the pain felt with the first step after waking up in the morning and the average pain level over the past week.
Time frame: Baseline
Physical Component Summary and Mental Component Summary
Time frame: Baseline
The Foot Function Index is a self-report-based scale developed to evaluate the effects of foot and ankle-related problems on pain, functional limitation, and daily life activities in individuals, with its validity and reliability demonstrated. AFI consists of three sub-dimensions: pain, disability (functional limitation), and activity limitation. The scale allows individuals to evaluate foot-related problems they have experienced recently in the context of daily life activities. Each sub-dimension and total score reflect the level of impairment in foot functions. Increasing AFI scores indicate that the severity of foot pain and the limitations in foot functions have increased, thereby negatively affecting foot-related quality of life. AFI is widely used in clinical and research settings to evaluate the functional effects of foot pathologies.
Time frame: Baseline
It is a valid and reliable self-report scale developed to assess individuals' exaggerated negative thoughts and emotional responses toward their pain experience. The scale measures cognitive and emotional responses that occur during or following pain and consists of three sub-dimensions: rumination (excessive focus on pain), magnification (exaggeration of the threatening consequences of pain), and helplessness.
Time frame: Baseline
It is a valid and reliable self-report scale developed to assess individuals' fear and avoidance behaviors toward movement and physical activity. The scale measures the level of fear of movement (kinesiophobia) that develops based on the belief that pain will reoccur or worsen.
Time frame: Baseline
The central sensitization scale is a tool used to assess the hypersensitivity of the central nervous system. This scale includes questions that examine individuals' pain perception and its effects on daily life to detect the effects of central sensitization, which are generally observed in chronic pain conditions. The scale evaluates how individuals perceive pain in response to physical contact or other stimuli (pain sensitivity), changes in their sensitivity to heat, cold, or pressure (sensory changes), how the persistence of pain affects their daily activities, and the impact of pain on their emotional state (anxiety, depression, etc.).
Time frame: Baseline
In the study, the evaluation with ultrasound will be conducted while the participants are in a prone position on the examination table, with their feet hanging off the table and in a dorsiflexed position. A linear probe will be placed longitudinally over the medial tubercle of the calcaneus to ultrasonographically examine the plantar fascia thickness (PFT). PFK will be measured 1 cm distal to the calcaneus attachment point. A PFK of 4 mm or greater will be considered evidence of fasciitis. It has been shown that this measurement technique has good intra-rater reliability. The Sonosite M-Turbo device will be used for ultrasonography and will be performed by a physical therapy and rehabilitation specialist with 10 years of experience.
Time frame: CROSS-SECTIONAL
It is a 14-item self-report scale that quickly, reliably, and independently of medical conditions assesses patients' anxiety and depression symptoms over the past week.
Time frame: Baseline
The range of motion of ankle dorsiflexion will be evaluated under load. The participant will be asked to keep their heel in contact with the ground and move their knee toward the wall, and the maximum distance between the thumb and the wall will be recorded in centimeters.
Time frame: Baseline
The participant's foot will be observationally scored based on six anatomical criteria in a standing natural posture, and the total score will be recorded.
Contact information is provided by the study sponsor or research team.
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Other
IInvestigation of the Relationship Between Central Sensitization and Clinical, Functional, and Ultrasonographic Parameters In Plantar Fasciitis
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