Evaluation of the Efficiency of ESWT and Custom İnsoles Produced With Podometric Measurement in the Treatment of Painful Heel Spurs (ESWT: Extracorporeal Shock Wave Therapy)

Study Overview
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Brief Summary
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The aim of the study; to determine the effectiveness customized insoles produced by podpmetric analysis and ESWT in patients with painfull heel spur and to determine the superiority of the treatments to each other.

Detailed Description
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Heel spurs are the most common cause of heel pain in adults. Pain that occurs in heel spur and radiates to the soles of the feet is characteristic of this disease. The pain is most severe in the first steps after rest. Patients typically complain of severe pain on the first steps after getting out of bed in the morning. The pain is partially relieved after a few steps, but may increase again after intense activities. Typical pain history and examination findings are important to diagnose heel spur, and the diagnosis is confirmed by lateral x-ray. Generally, most patients with heel spurs benefit from conservative and medical treatment, and only a few need surgery. These treatment methods include many options such as activity and shoes modifications, topical and oral NSAIDs, insoles, stretching and strengthening exercises, various injections. TENS, ultrasound, electrotherapy modalities that can be used in therapy to relieve pain and promote healing. Although many studies have been done for ESWT and insoles, there is not any study that comperes these two modalities. In this study, our aim is to investigate the effects of using ESWT and customized insoles alone or together on pain and foot functions in patients with heel spurs.

Official Title
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Evaluation of the Efficiency of ESWT and Custom İnsoles Produced With Podometric Measurement in the Treatment of Painful Heel Spurs

Conditions
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Heel Spur, Heel Spur Syndrome, Heel Pain Syndrome

Intervention / Treatment
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* Device: ESWT
* Device: customized insoles
* Combination Product: combined ESWT and custtomized insoles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18-65 years Pain in the heel for at least 3 weeks Confirmation of the diagnosis with lateral foot radiography Exclusion Criteria: Be younger than 18 and older than 65 Patients with systemic rheumatological disease (rheumatoid arthritis, ankylosing spondylitis etc.) Entrapment neuropathy in the lower extremities Systemic active infection Malignancy Pregnancy Coagulopathy Patients who have had a previous heel injection of steroids Patients who received physical therapy from the heel area in the last 6 weeks (TENS, ultrasound, hotpack, etc.) Inserted cardiac pacemaker Underweight, obese, and morbidly obese according to BMI Patients using NSAIDs and myorelaxants continuously

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESWT<br>Group 1 (n:16) will be given once a week, total 5 sessions of ESWT+ home exercise program | Device: ESWT<br>* will be given once a week, total 5 sessions ofESWT+ home exercises program<br>* Other names: Home exercise program( strengthening, stretching exercises, frozen water bottle rolling);|
| Experimental: customized insoles<br>Group 2 (n:16) will be given customized insoles+ home exercise program. Insoles will be used for 12 weeks. | Device: customized insoles<br>* Will be given customized insoles+ home exercise program. Insoles will be used for 12 weeks.<br>* Other names: Home exercise program( strengthening, stretching exercises, frozen water bottle rolling);|
| Experimental: combined ESWT and customized insoles<br>Group 3 (n:16) will be given once a week, total 5 sessions of ESWT+ home exercise program. Also, simultaneous insoles will be provided. Insoles will be used for 12 weeks. | Device: ESWT<br>* will be given once a week, total 5 sessions ofESWT+ home exercises program<br>* Other names: Home exercise program( strengthening, stretching exercises, frozen water bottle rolling);Device: customized insoles<br>* Will be given customized insoles+ home exercise program. Insoles will be used for 12 weeks.<br>* Other names: Home exercise program( strengthening, stretching exercises, frozen water bottle rolling);Combination Product: combined ESWT and custtomized insoles<br>* Will be given once a week, total 5 sessions of ESWT+ home exercise program. Also, simultaneous insoles will be provided. Insoles will be used for 12 weeks.<br>* Other names: Home exercise program( strengthening, stretching exercises, frozen water bottle rolling);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale | The self-evaluation of pain severity during rest, stretching and pressing on the medial calcaneal tubercle was calculated using a 10 cm VAS scale | Change from baseline at 12 weeks after treatment. | 
| American Orthopaedic Foot and Ankle Society (AOFAS) Pain Subscale | AOFAS scale includes three subscales (pain, function and alignment). Pain consists of one item with a maximal score of 40 points, indicating no pain. | Change from baseline at 12 weeks after treatment. | 
| Foot Function Index Pain Subscale | A Foot Function Index (FFI) was developed in 1991 to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. The pain subcategory consists of 9 items and measures foot pain in different situations, such as walking barefoot versus walking with shoes. | Change from baseline at 12 weeks after treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Roles and Maudsley Score | The Roles and Maudsley Score was used to evaluate pain and activity limitation as classified in four categories.1 point = excellent, 2 points = good, 3 points = fair and 4 points = poor | Change from baseline at 12 weeks after treatment. | 
| American Orthopaedic Foot and Ankle Society (AOFAS) Score | The AOFAS Ankle-Hindfoot Score is commonly used in patients with an ankle or hindfoot injury. This instrument combines functional outcome and pain, which are both critical for patients. The score consists of 3 subscales including alignment, pain, and function. | Change from baseline at 12 weeks after treatment. | 
| Foot Function Index | A Foot Function Index (FFI) was developed in 1991 to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. | Change from baseline at 12 weeks after treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heel spur, extracorporeal shock wave therapy, insole, customized insole