Clinical trial NCT05885243: 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)
Official title: Evaluation of the Efficiency of ESWT and Custom İnsoles Produced With Podometric Measurement in the Treatment of Painful Heel Spurs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heel Spur
Heel Spur Syndrome
Heel Pain Syndrome
Keywords: heel spur
extracorporeal shock wave therapy
insole
customized insole
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Change from baseline at 12 weeks after treatment.
measure: American Orthopaedic Foot and Ankle Society (AOFAS) Pain Subscale
timeFrame: Change from baseline at 12 weeks after treatment.
measure: Foot Function Index Pain Subscale
timeFrame: Change from baseline at 12 weeks after treatment.
Secondary outcomes:
measure: Roles and Maudsley Score
timeFrame: Change from baseline at 12 weeks after treatment.
measure: American Orthopaedic Foot and Ankle Society (AOFAS) Score
timeFrame: Change from baseline at 12 weeks after treatment.
measure: Foot Function Index
timeFrame: Change from baseline at 12 weeks after treatment.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: okan4494@yahoo.com
name: Okan Küçükakkaş, Doç
role: STUDY_DIRECTOR
affiliation: nsrn.ylmz@yahoo.com
name: Nesrin Yılmaz Baıramov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: elifdemirbag92@gmail.com
name: Elif Uğurlu, MD
role: STUDY_CHAIR
References:
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.
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.
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.
citation: 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.
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.
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.