The Effect of Kinesio-tape and Shock Wave Therapy on Plantar Fasciitis

Study Overview
=================
Brief Summary
-----------------
Foot problems are common in society. Accordingly, loss of workforce, quality of life and mental health deterioration can be observed in employees and hardship in daily life activities, balance-walking problems and fall risk increase in older adults. The presence of athletic and sedentary populations causes a large number of patients to apply to outpatient clinics with the complaint of heel pain every year. Plantar fasciitis (plantar heel pain), although multifactorial origin, obesity, overload bearing and ankle joint motion reduction factors are thought to play an active role in the emergence of discomfort. Foot orthoses are a common treatment used for plantar heel pain, but a period of several weeks is usually required between the diagnosis and transportation to the orthosis due to the production process. Therefore, short-term therapies such as supportive banding are used to alleviate the symptoms of this intermediate period. The low-dye taping technique is the most commonly used banding technique and has been found to be effective in randomized controlled trials. In addition, there is a rare study in the literature showing the efficacy of Kinesio taping method. Although both were found to be useful in the treatment of plantar fasciitis, no randomized controlled trial was studied in this patient population of the low-dye method with Kinesio taping. In the studies, the early period of banding therapy is mentioned and studies on relatively longer treatment response are still required. Our hypothesis is that low-dye Kinesio-banding treatment added to ESWT treatment for patients diagnosed with plantar fasciitis will be effective on foot functionality by reducing the pain of the patient both in the early and later period.

Detailed Description
-----------------
One of the most common musculoskeletal pathologies of the foot and pain is plantar heel pain. In the studies, it was stated that the feeling of foot pain and stiffness was between 18% and 63%. The plantar fascia is the most common cause of heel pain in adult age. Due to overuse, such as standing for a long time or running, it is assumed that it occurs as a result of micro-injury on the surface of the plantar fascia. It has been reported that 10% of the general population will be encountered throughout life. Although the exact cause is not known, middle age, obesity, excessive foot pronation, pes cavus, running, pes planus and long-term standing are among the reasons that facilitate. Patients experience severe pain in the first step they take after sitting for a long time or when they get up in the morning and start to walk and the pain is triggered by the tension of the plantar fascia and overlapping weight onto the foot. A large number of conservative methods have been used in the treatment of plantar fasciitis. Anti-inflammatory agents (Non-steroidal anti-inflammatory drugs, steroid injections), physical therapy modalities (iontophoresis, ultrasound, extracorporeal shock wave therapy, electrical stimulation, cryotherapy, and whirlpool), manual therapy, stretching therapy and external support (orthosis and banding) treatment most of these methods. Orthosis and taping aim to correct poor biomechanics in the foot while most of the other treatment programs are suppressing symptoms. Extracorporeal shock wave therapy (ESWT), which is another treatment modality that is used effectively in treatment, is currently preferred in delayed and nonunion fractures, calcified tendinitis of the shoulder, lateral epicondylitis, plantar fasciitis, patellar tendinitis, and calcaneal spur. In a recent prospective study, ESWT treatment was not superior to Kinesio-taping, and both treatments were found to be similar in both pain reduction and increased functionality.

Official Title
-----------------
The Effect of Low-dye Kinesio Taping in Addition to Extracorporeal Shock Wave Therapy in Patients With Plantar Fasciitis

Conditions
-----------------
Plantar Fascitis, Calcaneus Spur

Intervention / Treatment
-----------------
* Device: Kinesio tape
* Device: Extracorporeal shock wave therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pain when the plantar fascia is palpated, Imaging of calcaneal spur radiographically, Description of the first step pain, after prolonged resting or awakening in the morning Continue with pain despite other conservative methods (NSAI, exercise, etc.) Exclusion Criteria: History of steroid injection in the heel region for the same diagnosis in the last three months, Rheumatic disease, Coagulopathy, thrombophlebitis, neoplasia, systemic inflammatory diseases, Foot and or lumbar surgery, symptoms of lumbar radiculopathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESWT+ Kinesiotaping<br>Low-dye Kinesio taping technique 4 times in 5 weeks in addition to extracorporeal shock wave therapy | Device: Kinesio tape<br>* Kinesio tape will be applied on the plantar heel (the most painful area) of the patients for the treatment of plantar fasciitis, in addition to the extracorporeal shock wave therapy<br>Device: Extracorporeal shock wave therapy<br>* Extracorporeal shock wave therapy will be used for all patients with plantar fasciitis. (5 sessions for 5-week)<br>|
| Sham Comparator: ESWT+Shamtaping<br>Sham taping technique 4 times in 5 weeks in addition to extracorporeal shock wave therapy | Device: Kinesio tape<br>* Kinesio tape will be applied on the plantar heel (the most painful area) of the patients for the treatment of plantar fasciitis, in addition to the extracorporeal shock wave therapy<br>Device: Extracorporeal shock wave therapy<br>* Extracorporeal shock wave therapy will be used for all patients with plantar fasciitis. (5 sessions for 5-week)<br>|
| Other: ESWT<br>Extracorporeal shock wave therapy for 5 sessions (5-week) | Device: Extracorporeal shock wave therapy<br>* Extracorporeal shock wave therapy will be used for all patients with plantar fasciitis. (5 sessions for 5-week)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale | Pain on the plantar heel were evaluated with the visual analog scale (0-10 mm). High scores indicate increased pain. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heel tenderness index | Evaluation of the sensitivity of the heel by the physician (Heel tenderness index: 0= no pain, 1= painful, 2= painful and winces and 3= painful, winces and withdraws). | 30 days | 
| Foot function index | It measures the impact of foot pathology on function in terms of pain, disability and activity restriction. The questionnaire consists of 23 self-reported items divided into 3 subscales on the basis of patient values: pain, disability and activity limitation. | 30 days |