Heel Pain Syndrome Clinical Trial
— eswtOfficial title:
Evaluation of the Efficiency of ESWT and Custom İnsoles Produced With Podometric Measurement in the Treatment of Painful Heel Spurs
NCT number | NCT05885243 |
Other study ID # | 4.2019/10 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2023 |
Est. completion date | June 15, 2023 |
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.
Status | Recruiting |
Enrollment | 48 |
Est. completion date | June 15, 2023 |
Est. primary completion date | June 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Bezmialem Vakif University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Bezmialem Vakif University |
Turkey,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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 | 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. | |
Secondary | 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. | |
Secondary | 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. |
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