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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Foot Core Stabilization Exercise Group (FCSEG)
Foot Core Stabilization Exercise Group (FCSEG)
干预措施: Foot Core Stabilization Exercise Group (FCSEG) (Other)
Extracorporeal Shock Wave Therapy Group (ESWTG)
Extracorporeal Shock Wave Therapy Group (ESWTG)
干预措施: Extracorporeal Shock Wave Therapy Group (ESWTG) (Other)
结局指标
主要结局
Pain
时间窗: through study completion, an average of 6 months.
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.
Medial longitudinal arc level
时间窗: through study completion, an average of 6 months.
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).
Muscle strength
时间窗: through study completion, an average of 6 months.
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.
Quadriceps angle
时间窗: through study completion, an average of 6 months.
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
次要结局
- Foot posture index(through study completion, an average of 6 months.)
- Foot function index(through study completion, an average of 6 months.)
研究者
gulay karacaoglu
asisstant prof.
Istanbul Medipol University Hospital