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)
eswt
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2023
CompletedFirst Submitted
Initial submission to the registry
May 23, 2023
CompletedFirst Posted
Study publicly available on registry
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2023
CompletedJune 1, 2023
May 1, 2023
4 months
May 23, 2023
May 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
Roles and Maudsley Score
Change from baseline at 12 weeks after treatment.
American Orthopaedic Foot and Ankle Society (AOFAS) Score
Change from baseline at 12 weeks after treatment.
Foot Function Index
Change from baseline at 12 weeks after treatment.
Study Arms (3)
ESWT
EXPERIMENTALGroup 1 (n:16) will be given once a week, total 5 sessions of ESWT+ home exercise program
customized insoles
EXPERIMENTALGroup 2 (n:16) will be given customized insoles+ home exercise program. Insoles will be used for 12 weeks.
combined ESWT and customized insoles
EXPERIMENTALGroup 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.
Interventions
will be given once a week, total 5 sessions ofESWT+ home exercises program
Will be given customized insoles+ home exercise program. Insoles will be used for 12 weeks.
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.
Eligibility Criteria
You may qualify if:
- Aged between 18-65 years
- Pain in the heel for at least 3 weeks
- Confirmation of the diagnosis with lateral foot radiography
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bezmialem Vakif University
Istanbul, Turkey (Türkiye)
Related Publications (6)
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.
PMID: 25941995BACKGROUNDYan 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.
PMID: 25544167BACKGROUNDCohena-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.
PMID: 33233945BACKGROUNDCaglar 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.
PMID: 31186388BACKGROUNDRibeiro 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.
PMID: 35964021BACKGROUNDLandorf 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.
PMID: 16801514BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Okan Küçükakkaş, Doç
okan4494@yahoo.com
- PRINCIPAL INVESTIGATOR
Nesrin Yılmaz Baıramov, MD
nsrn.ylmz@yahoo.com
- STUDY CHAIR
Elif Uğurlu, MD
elifdemirbag92@gmail.com
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2023
First Posted
June 1, 2023
Study Start
March 1, 2023
Primary Completion
June 15, 2023
Study Completion
June 15, 2023
Last Updated
June 1, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share