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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESWT | Experimental | Group 1 (n:16) will be given once a week, total 5 sessions of ESWT+ home exercise program |
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| customized insoles | Experimental | Group 2 (n:16) will be given customized insoles+ home exercise program. Insoles will be used for 12 weeks. |
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| combined ESWT and customized insoles | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESWT | Device | will be given once a week, total 5 sessions ofESWT+ home exercises program |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mehmet Hakan Özdemir | Contact | +902124530453 | mozdemir@bezmialem.edu.tr | |
| Okan Küçükakkaş, Doç | Contact | +905064334436 | okan4494@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Okan Küçükakkaş, Doç | okan4494@yahoo.com | Study Director |
| Nesrin Yılmaz Baıramov, MD | nsrn.ylmz@yahoo.com | Principal Investigator |
| Elif Uğurlu, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bezmialem Vakif University | Recruiting | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25941995 | Background | Wrobel JS, Fleischer AE, Crews RT, Jarrett B, Najafi B. A randomized controlled trial of custom foot orthoses for the treatment of plantar heel pain. J Am Podiatr Med Assoc. 2015 Jul;105(4):281-94. doi: 10.7547/13-122.1. Epub 2015 May 5. | |
| 25544167 | Background | Yan W, Sun S, Li X. [Therapeutic effect of extracorporeal shock wave combined with orthopaedic insole on plantar fasciitis]. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2014 Dec;39(12):1326-30. doi: 10.11817/j.issn.1672-7347.2014.12.017. Chinese. |
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| customized insoles | Device | Will be given customized insoles+ home exercise program. Insoles will be used for 12 weeks. |
|
|
| combined ESWT and custtomized insoles | Combination Product | 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. |
|
|
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. |
| elifdemirbag92@gmail.com |
| Study Chair |
| 33233945 | Background | Cohena-Jimenez M, Pabon-Carrasco M, Perez Belloso AJ. Comparison between customised foot orthoses and insole combined with the use of extracorporeal shock wave therapy in plantar fasciitis, medium-term follow-up results: A randomised controlled trial. Clin Rehabil. 2021 May;35(5):740-749. doi: 10.1177/0269215520976619. Epub 2020 Nov 24. |
| 31186388 | Background | Caglar Okur S, Aydin A. Comparison of extracorporeal shock wave therapy with custom foot orthotics in plantar fasciitis treatment: A prospective randomized one-year follow-up study. J Musculoskelet Neuronal Interact. 2019 Jun 1;19(2):178-186. |
| 35964021 | Background | Ribeiro AP, de Souza BL, Joao SMA. Effectiveness of mechanical treatment with customized insole and minimalist flexible footwear for women with calcaneal spur: randomized controlled trial. BMC Musculoskelet Disord. 2022 Aug 13;23(1):773. doi: 10.1186/s12891-022-05729-4. |
| 16801514 | Background | Landorf KB, Keenan AM, Herbert RD. Effectiveness of foot orthoses to treat plantar fasciitis: a randomized trial. Arch Intern Med. 2006 Jun 26;166(12):1305-10. doi: 10.1001/archinte.166.12.1305. |
| ID | Term |
|---|---|
| D036982 | Heel Spur |
| D036981 | Fasciitis, Plantar |
| ID | Term |
|---|---|
| D005096 | Exostoses |
| D015576 | Hyperostosis |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
| D005208 | Fasciitis |
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