Clinical Trials Updates

NewsBot · Aug 12, 2023

Plantar Pressure Distribution in Diabetic Foot Ulcer (PPDDFU)

The goal of this clinical trial is to find out the changes in peak pressure and pressure-time integral after twelve weeks from the initial utility of foot insoles and eight weeks later as a follow-up in diabetic foot ulcers. Participants will be randomly assigned to foot insole, medication, and wound care (study group) or medication and wound care (control group).
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NewsBot · Aug 13, 2023

Comparative Effects of Dry Needling and Cross Friction Massage on Patients With Plantar Fascitis, RCT

Effectiveness Comparative Effects of Dry Needling and Cross Friction Massage on Patients With Plantar Fascitis
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NewsBot · Aug 15, 2023

Influence of Foot Types on Collegiate Athletes

The purpose of the study is to assess whether high or low arch foot types influence the overall performance of the athlete.
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NewsBot · Aug 19, 2023

Use of the Unstable Shoes in Lower Limb Lymphedema.

Lymphedema is an external manifestation of lymphatic system insufficiency and deranged lymph transport. It is defined as accumulation in the extracellular space of protein-rich fluid, due to a mechanical failure of the lymphatic system. Lymphedema directly affects the quality of life of the patient, not only in the physical aspect, but also in the psychological, sexual and social aspects. Muscle and joint pumps are important external mechanisms of lymphatic and venous fluid return improvement. The unstable shoes demands, especially during standing, increased muscle activity in the lower extremities. A clinical trial was carried out comparing both kinds of footwear, the objective being to evaluate possible differences in the evolution of lymphedema. Unstable shoes (MBT®) were compared with conventional sports shoes. During a clinical trial lasting eight weeks, we assessed quality of life, limb volume, and symptoms derived from lymphedema. The results suggested that the use of unstable shoes is recommendable for walking and for long periods of standing, since it decreases leg cramping and paraesthesia of affected limbs.
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NewsBot · Aug 22, 2023

Proof of Concept Open Label, Clinical Trial to Evaluate the Safety and Efficacy of the "FITT" Device in Diabetic Foot Ulcers Patients (TriO FITT)

The TriO FITT device is designed to improve the symptoms of chronic diabetic ulcers.

The mechanism of action of the device optimizes and combines the administration known supproting treatments to chronic diabetic ulcers. The treatment is astimated to improve the wound conditions of acute and chronic diabetic wounds.
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NewsBot · Aug 24, 2023

Pedal Acceleration Time (PAT) as a Measure of Foot Perfusion (PAT)

To identify a correlation between Toe Brachial pressure Index (TBPI) and Acceleration time of the pedal vessels. The aim would then to use this data to design a clinical study assessing the relationship between PAT and wound healing in patients with PAD.
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NewsBot · Sep 6, 2023

Clinico-Radiological Characterisation for Remission of Acute Charcot-Neuroarthropathy of Foot.

Charcot's neuro-arthropathy is a condition which is generally prevalent among the diabetic patients. Acute charcot's neuro-arthropathy is characterized by signs of inflammation, hot, red swelling around the involved joint along with a temperature difference of greater than 2 degree centigrade between the two feet. This is often misdiagnosed as cellulitis, sprains or deep vein thrombosis. The diagnosis of this condition is mainly made clinically and aided by x-ray of foot, MRI of foot and sometimes by bone scan. The therapy that is accepted unanimously is putting on a total contact cast. The duration of this therapy depends on the regular temperature monitoring of both the feet. When the temperature difference between the two feet comes down to less than 2 degree centigrade, then it is defined as clinical remission and the offloading of the foot is stopped. There are other modalities that have been tried for the treatment of acute charcot's neuro-arthropathy with medications like methyl prednisolone, bisphosphonates and the effects of medical management of acute charcot's neuro-arthropathy was a mixed one with no definite recommendation regarding use of medical management in this condition. If the patients are denied these treatment then there is progression of the disease process and can lead to the development of chronic changes in the form of fractures, dislocation, gangrene, foot ulcers and ultimately amputation. The end point of the treatment with total contact cast is taken as the decrease in the temperature difference of less than 2 degree centigrade between the two feet. This point is regarded as the point of clinical remission in cases of acute charcot's neuro-arthropathy. But there has been instances where there have been 12-33% of recurrences when this clinical remission has been used as a criteria for discontinuation of offloading. With time, there has been evolution in the imaging of charcot's neuro-arthropathy. There has been advent of MRI and MRS of the foot for monitoring of acute charcot's neuro-arthropathy remission which is the most sensitive technique for the recognition of early bony changes in charcot neuro-arthropathy. PET scan has also been used including bone scan and FDG PET scan, for the evaluation of acute charcot's neuro-arthropathy remission. Even with these modalities the actual remission criteria that would decrease the complication of early offloading as done at the time of clinical remission, is still missing. So here the investigators aim to monitor the process of remission of acute charcot-neuroarthopathy of foot both clinically as well as radiologically with the help of MRI of the foot with diffusion weighted and apparent diffusion coefficient imaging along with a novel PET scan for charcot's neuroarthropathy, that is F18-Fluoride PET scan which will given a quantitative estimation of the process of remission of acute charcot-neuroarthropathy in the form of SUV max. Thus this quantitative value can help to assess the trends of remission in acute charcot neuroarthropathy of foot.
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NewsBot · Sep 7, 2023

Pressure Alternating Shoes (PAS) for Prevention of Diabetic Foot Ulcers

The project is designed to develop and test Pressure Alternating Shoes (PAS), which will periodically off-load certain regions of the foot in order to prevent foot ulcers. An automated dual layer insole compromised of an active pressurized actuator array in combination with a passive compliant layer on top of each actuator to modulate and distribute the plantar surface pressure as desired will be tested. This device will allow us to simultaneously load and offload select areas of the foot using the active layer by inflating and deflating individual actuators using pressurized air. After offloading, the remaining load will be distributed to other areas with inflated actuators. Automatic modulation will be provided through programmable control hardware which will cyclically relieve mechanical loading based on a prescribed duration and frequency.
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NewsBot · Sep 8, 2023

Use of AC5® Advanced Wound System in the Treatment of Diabetic Foot Ulcers

The purpose of this clinical evaluation is to collect and compare outcomes data from patients with UT 1A diabetic foot ulcers treated with 510K FDA cleared, commercially available self-assembling peptide, AC5®Advanced Wound System, as compared to an advanced standard of care. Patient outcomes will be compared at the end of the study.
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NewsBot · Sep 10, 2023

Effect of Additional Treatment With NMES After Achilles Tendon Rupture

Brief Summary:
Increased knowledge is needed about new methods how to treat patients with Achilles tendon ruptures (ATR). A goal is to be able to individualize as well as improve treatment beyond the question about if surgery should be used or not.

An overall aim of the project is to, in a randomized controlled trial (RCT), explore what impact a new treatment method with Neuromuscular Electrical Stimulation (NMES) - attached on the patients ́ calf muscles on the injured leg - in the early stages after an ATR, may have on tendon length, functional performance, biomechanical variables and patient reported outcome, both in the short and long term after the injury. 70 patients are planned to be included in this RCT and will be evaluated 3,6 and 12 months after their injury. Primary outcome will be heel-rise height. Secondary outcome will be tendon length, jumping ability, patient- reported outcome and biomechanical loading pattern.

There is also a need to explore if the patients ́ loading patterns improve after treatment with NMES. Therefore, biomechanical variables in lower leg during walking and jumping will also be evaluated one year after their injury.

The planned studies include completely new ways of exploring how to optimize the rehabilitation after an ATR.

Since there might be an increased risk for overuse injuries in the healthy limb, there will also be focus on how the non- injured limb may be affected of an ATR.

Taken together, this new knowledge can be helpful in the clinical setting to individualize and optimize patients' treatment and rehabilitation with the goal to guide the patient return to the same, or higher level of, physical activity as before the injury.
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NewsBot · Sep 10, 2023

Peer Support for Patients With Diabetic Foot Ulcers

The objective of the study is to develop a peer support program that helps improve ulcer care in patients with a diabetic foot ulcer (DFU).Diabetes, peripheral arterial disease (PAD), foot ulceration, and subsequent amputation are unevenly patterned in terms of racial/ethnicity, socioeconomic status, health insurance, and geographic area. The project will identify opportunities to reduce health disparities among economically marginalized patients regarding DFU outcomes.
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NewsBot · Sep 11, 2023

In-shoe Pressures Associated With Footwear Fit Guidelines

One in five foot ulcers are caused by the footwear worn by people with diabetes, yet there is a lack of consensus around footwear fit. Recommended toe gaps (the gap between the longest toe and the inside of the shoe) vary depending on the footwear guidance referred to but no research to date has assessed their effectiveness in minimising in-shoe pressures.

The investigators will carry out a pilot study in 60 people with diabetes and loss of sensation in their feet (neuropathy). In this study, the investigators will measure in-shoe pressures whilst participants walk at the same pace to the beat of a metronome. An insole placed inside their shoes will measure in-shoe pressures. Participants will wear the same (standardised) type of footwear. The study is designed to detect a difference in pressure within this made-to-measure footwear between shoes whose fit conforms to Standard 1 guidance compared with those whose fit conforms to Standard 2 guidance. Differences between Standards 1 and 2 with Standard 3 will be considered secondary analyses. Standards are simplified to three non-overlapping recommended toe gap ranges of 0.5-1.0cm; 1.5-2.0cm and 1.0-1.5cm.

The investigators will also analyse the heat images taken with a thermographic camera before and after walking in standardised footwear whose fit confirms to these standards (this is known as the plantar thermal stress response to walking). Footwear fit will be determined by measuring the dimensions of participants' feet and that of their footwear and comparing the two.

The investigators will also measure footwear fit and associated in-shoe pressure/plantar thermal stress response in participants' habitual footwear during walking at paced and self-selected speeds.
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NewsBot · Sep 12, 2023

Investigation of the Effect of Foot Muscle Fatigue on the Foot Sole and Tendon Structural Properties

In healthy individuals, fatigue in the foot muscles increases the load and stress on the feet. The extrinsic muscles of the foot, which investigators aimed to create fatigue in this study, are closely related anatomically and functionally to the plantar fascia and Achilles tendon. Considering that fatigue or weakness of the foot extrinsic muscles is an important risk factor for foot-ankle pathologies, it is important to reveal the relationship with the plantar fascia and Achilles tendon in healthy sedentary individuals and to determine mechanical properties of the feet of the participants to prevent possible foot injuries. Therefore, the aim of this study is to show the acute effects of fatigue in the extrinsic muscles of the foot on the viscoelastic properties of the plantar fascia and Achilles tendon. The study was completed with 19 people who met the inclusion criteria. Before starting the study, the dominant foot of the participants was determined, physical activity level was determined, foot posture index and foot posture were evaluated, navicular height and fall distance of the foot were measured, m.gastrocnemius shortness was measured with the Silfverskiöld test, flexibility was evaluated with a baseline sitting bench, tendon and fascia measurements were made with the MyotonPRO device. After the measurements, the participant was trained to perform the heel raise exercise. When the exercise was completed, the participant's foot Myoton measurements were repeated. One week later, pre-exercise Myoton measurement was performed, then the participant was trained for the foot adduction exercise. When the exercise was completed, the participant's foot Myotone measurements were repeated. In another week, pre-exercise Myotone measurement was performed, then heel raising and foot adduction exercises were performed sequentially. When the exercise was completed, the participant's foot Myoton measurements were repeated.
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NewsBot · Sep 13, 2023

Myofascial Pain Syndrome and Plantar Fasciitis Treatment

Patients with plantar fasciitis between the ages of 25-65 years who presented to the Physical Medicine and Rehabilitation clinic with the complaint of heel pain and met the inclusion and exclusion criteria will be included in the study. Demographic data (age, gender, body mass index, symptom duration) will be recorded at the beginning of the study. Then, Foot Functional Index (FFI) and Visual Analog Scale (VAS) scales will be recorded. Participants will be randomly divided into two groups. Group 1 will receive dry needling and Group 2 will receive extracorporeal shock wave therapy (ESWT). Patients in the 1st group will undergo 3 sessions of dry needling with Seirin branded 0.6*50 mm acupuncture needles at one week intervals for the trigger point detected by manual palpation in the medial gastrocnemius, lateral gastrocnemius, soleus, flexor digitorum brevis, quadratus plantae, abductor hallucis brevis muscles. Patients in the 2nd group will receive 3 sessions of ESWT (MASTERPLUS MP 200 ENERGY 2 brand ESWT device) with a frequency of 12-15 Hz, 2-3 bars and 2500 pulses once a week. ESWT will be applied to the 5 most sensitive points of the plantar fascia with equal shares of 2500 pulses.
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NewsBot · Sep 14, 2023

Randomized Clinical Study Evaluating Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers

The study will evaluate the safety and performance of Symphony™ versus Standard of Care (SOC) in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment
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NewsBot · Sep 14, 2023

Effect of Augmented Low-dye* Taping and Exercise on Plantar Pressure, Navicular Drop and Foot Posture in Pes Planus (Ald)

Introduction: Pes planus is a deformity that affects the foot-ankle muscle complex as well as passive components of the foot such as bones and ligaments. Various approaches such as taping methods and exercise training are being investigated in the treatment of pes planus. The effect of the applied methods and their superiority over each other are still unclear. The effect of banding methods varies according to the band type and technique. Exercise methods currently focus on the intrinsic and extrinsic muscles of the foot. Pedobarographic evaluations are also performed in addition to clinical evaluations to evaluate the effectiveness of treatments.

Objective: It is planned to compare the effects of reinforced low-dye taping method, which is one of the rigid taping techniques used in the treatment of pes planus, and exercise training on foot plantar pressure, navicular drop and foot posture.

Material and method: 34 individuals with pes planus between the ages of 18-25 will be included in the study, which was designed as a single-blind randomized study. The universe of our study will be Lokman Hekim University Faculty of Health Sciences and Institute of Health Sciences. The whole universe will be tried to be reached and individuals who meet the inclusion criteria will be selected from the relevant universe. Consent form will be obtained from individuals who are deemed eligible to participate in the study. Pes planus evaluation; It will be done using the navicular drop test and the foot posture index. In order for the physical activity levels of the groups to be homogeneous, after stratified sampling, individuals will be randomly assigned to the exercise groups by taping and exercise with the closed envelope method. Evaluations will be made to each group at the beginning, at the eighth and twelfth week. Static evaluation of the foot will be made using navicular drop and foot posture index, and pedobarographic analysis will be done using a foot analyzer.

Conclusion: The effects of taping and exercise training on foot static and plantar pressure measurements will be interpreted.
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NewsBot · Sep 14, 2023

Effectiveness of Customised 3D-printed Insoles in Reducing Pain Among Frequent Park Runners

This study evaluates the effectiveness of the Zoles customised 3D-printed insoles to mitigate running-related pain among frequent recreational runners who participate in regular Park Run activities. All participants will have their feet scanned, after which half of the participants will be provided with customised 3D-printed insoles, while the other half will receive no intervention.
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NewsBot · Sep 14, 2023

Plantar Fascia Release With Magnetic Fascia Ball

In this study, the effect of plantar fascia release with a magnetic fascial cork ball on hamstring and lumbar extensor muscle elasticity will be investigated.
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NewsBot · Sep 14, 2023

The Effect of Motivational Interviewing on Treatment Adherence, Self-Efficacy, and Satisfaction in Individuals With Diabetic Foot Ulcers

The rise in diabetes incidence has led to a corresponding increase in diabetes-related complications. Diabetic foot ulcers, a severe consequence of diabetes, have substantial impacts on patients, the social environment, overall well-being, and nursing procedures. Given this context, there is a clear necessity for interventions that motivate patients to adopt beneficial health behaviors and educate them in effectively managing diabetes-related complications. This study seeks to investigate the impact of Watson's motivational interviewing method, which is grounded in the human care theory, on enhancing treatment adherence, self-efficacy, and satisfaction levels among individuals suffering from diabetic foot ulcers.

Hypotheses of The Research H0: There is no difference in self-efficacy for diabetic foot care, diabetic foot care behavior, treatment adherence, and satisfaction between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education, and those who receive standard education.

H1: There is a difference in self-efficacy for diabetic foot care between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education and those who receive standard education.

H2: There is a difference in diabetic foot care behavior between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education and those who receive standard education.

H3: There is a difference in treatment adherence between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education and those who receive standard education.

H4: There is a difference in satisfaction between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education and those who receive standard education.
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NewsBot · Sep 15, 2023

Immediate Effects of Myofascial Release Techniques on Balance in Young Adults With Pes Planus

The plantar fascia is a thick, multi-layered, non-elastic fibrous tissue band that extends along the plantar surface of the foot.The configuration of the plantar fascia is generally considered as a dense, longitudinally arranged fiber band divided into medial, central, and lateral components. The most significant functional role of the plantar fascia is to maintain the arch structure of the foot, providing a stable support base while standing and absorbing dynamic reaction forces during walking.Pes planus is a rather general term with many definitions. Staheli described pes planus as a "foot with a broad base of support," commonly known as flatfoot in layman's terms. In a study involving 80 female participants aged 65 and older, 90% of foot deformities observed while standing were identified as pes planus. Generally, pes planus is a condition characterized by excessive pronation of the rear part of the foot and a lowering of the medial longitudinal arch. During the push-off phase of walking, the pronation moment generated by the ground reaction force flattens the arch as the subtalar joint rotation combines. The shift in position in the talus bone causes the navicular bone to drop. The plantar calcaneonavicular ligament tightens, and the tibialis posterior muscle lengthens. Abnormalities in the bones of the foot, dysfunction of the tibialis posterior muscle, Achilles tendon shortening, or muscle weakness can contribute to pes planus. Individuals with pes planus may experience foot and leg pain with exercise, physical activity, and prolonged walking, which can limit their level of physical activity. Research has examined the relationship between pes planus and various physical parameters, and it has been found that one of these parameters, balance, is negatively affected by the presence of pes planus.
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NewsBot · Sep 17, 2023

The Effect of Serial Casting and Physical Therapy in Children With Idiopathic Toe Walking

Brief Summary:
Children who continue to walk on their tiptoes after developing a heel-toe gait normally are diagnosed with idiopathic toe walking (ITW). The study's aim was to investigate the effects of serial casting and physical therapy on joint range of motion (ROM), toe walking severity, functional health and health-related quality of life, walking balance, and satisfaction from treatment in ITW, in comparison with the control group.
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NewsBot · Sep 20, 2023

Study for Treatment of Chronic Diabetic Foot Ulcers With the Investigational Allogeneic Cell Therapy Product, hOMSC200

Purpose of this phase 1/2a study is to assess the safety and efficacy of administration of allogeneic human oral mucosal stem cells (hOMSCs) in patients suffering from chronic diabetic foot ulcers (DFU).
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NewsBot · Sep 22, 2023

Comparison of the Efficiency of ESWT and Ozone Injection in Patients With Chronic Plantar Fasciitis

Extracorporeal Shock Wave Therapy (ESWT) is a conservative treatment method that has been widely used in musculoskeletal diseases in recent years. Its mechanism is to provide hyperstimulation and vascularity increase with the help of acoustic waves focused on a specific area, thus accelerating healing and reducing pain. This method, which is frequently used in plantar fasciitis, is frequently applied to patients whose symptoms persist despite first-line treatment strategies.

Ozone injections have been frequently used in musculoskeletal disorders in recent years and are mainly used in osteoarthritis, osteomyelitis, tendon, fascia and ligament injuries, vertebra and disc pathologies and neuropathic pain. Analgesic effect on musculoskeletal system (release of endorphins, activation of antinociceptive system, reduction of edema) anti-inflammatory effect (regulation of cytokine release, reduction of superoxide radicals, modulation of prostaglandin), regulation of local oxygenation and circulation, tissue repair (neutralization of preteolytic enzymes, fibroblast proliferation) and has an antimicrobial effect. Although it is also used in the treatment of plantar fasciitis, there are limited articles on this subject in the literature.

In our study, it was aimed to compare the effectiveness of ESWT and ozone injection therapy, which are two treatment strategies with regenerative action mechanisms, in patients with resistant plantar fasciitis.
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NewsBot · Sep 26, 2023 at 12:44 AM

Remote Monitoring of the Diabetic Foot to Prevent Re-Ulceration (MASTER)

Brief Summary:
The purpose of this study is to understand the effects of the Bluedrop Monitoring System (BMS) on the development of diabetic foot ulcers.

All Participants in this study will continue with their normal foot care and complete surveys with questions about their foot health every three months.

Participants selected to receive the BMS will place it in their home and stand on it once a day for 12 months. Participants will also need to answer questions about their general foot health and, if using the system, their experience using the device and monitoring service.
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NewsBot · Sep 27, 2023 at 10:21 AM

Infrared Bioeffect System for the Treatment of Onychomycosis

Onychomycosis is a common nail plate infection caused by dermatophytes, non-dermatophytic molds, and yeasts. The disease is difficult to achieve self-healing and predisposed to secondary bacterial infections. There are currently multiple medications that can be used for the treatment of onychomycosis. The limitations are high recurrence rate and high cost, time-consuming and drug interactions. Several FDA approved laser devices have been available for the treatment of onychomycosis since 2010. As an emerging physical therapy modality, laser and light have advantages including extensive applicable range, simple operation, less trauma, and it will not lead to generation of new resistant strains. Therefore, it has been popularized and applied in clinics, especially among elderly, immunocompromised patients, or those with liver and kidney dysfunction. Laser systems in the near-infrared spectrum (780 nm∼ 3,000 nm wavelength), which are commonly used in onychomycosis, exert their effect by direct heating of target tissues, but it can cause unbearable physical pain to the patient. Compared with laser, controllable infrared bioeffect system has the advantages of high safety, less trauma, and less pain. Reported in the literature, it has been observed that regression of distant, untreated skin lesions in patients treated locally with controllable infrared bioeffect system, especially in inflammatory skin diseases such as viral warts and sporotrichosis. The aim of the research is to evaluate the safety and efficacy of controllable infrared bioeffect system in treatment of onychomycosis.
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NewsBot · Sep 29, 2023 at 1:38 AM

Effect of Kinesio Taping and Extracorporeal Shock Wave Therapy on Plantar Fasciitis

Type of this study: Prospective randomized controlled study. Purpose: The aim of this study is to compare the acute effect of pain level, lower extremity functionality level and plantar fascia flexibility in patients with plantar fasciitis receiving Exportacorporeal Shock Therapy (ESWT).

To compare the acute effect of pain level, lower extremity functionality level and plantar fascia flexibility in patients with plantar fasciitis who received KT application in addition to ESWT treatment.

To compare the acute effect of pain level, lower extremity functionality level and plantar fascia flexibility in patients with plantar fasciitis receiving placebo application.

90 volunteers will be included in the study as ESWT (n=30), placebo ESWT (n=30), ESWT and KT (n=30) application groups. How effective is ESWT, ESWT and Kinesiotape versus placebo ESWT acutely in the treatment of plantar fasciitis?
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Clinical Trials Updates

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Discrepeances in foot related clinical trials between registration and publications

Sham or placebo foot orthotics for use in clinical trials

"sham" foot orthoses and clinical trials

Timing and Completeness of Trial Results Posted at ClinicalTrials.gov and Published in Journals

What outcomes are important in clinical trials

Western clinical trials bad for traditional medicine

Clinical trials involving footwear & orthotics

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Clinical Trials Updates

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Discrepeances in foot related clinical trials between registration and publications

Sham or placebo foot orthotics for use in clinical trials

"sham" foot orthoses and clinical trials

Timing and Completeness of Trial Results Posted at ClinicalTrials.gov and Published in Journals

What outcomes are important in clinical trials

Western clinical trials bad for traditional medicine

Clinical trials involving footwear & orthotics

Share This Page

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