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)

NCT ID: NCT05885243

Last Updated: 2023-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-06-15

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.

Conditions

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Heel Spur Heel Spur Syndrome Heel Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ESWT

Group 1 (n:16) will be given once a week, total 5 sessions of ESWT+ home exercise program

Group Type EXPERIMENTAL

ESWT

Intervention Type DEVICE

will be given once a week, total 5 sessions ofESWT+ home exercises program

customized insoles

Group 2 (n:16) will be given customized insoles+ home exercise program. Insoles will be used for 12 weeks.

Group Type EXPERIMENTAL

customized insoles

Intervention Type DEVICE

Will be given customized insoles+ home exercise program. Insoles will be used for 12 weeks.

combined ESWT and customized insoles

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.

Group Type EXPERIMENTAL

ESWT

Intervention Type DEVICE

will be given once a week, total 5 sessions ofESWT+ home exercises program

customized insoles

Intervention Type DEVICE

Will be given customized insoles+ home exercise program. Insoles will be used for 12 weeks.

combined ESWT and custtomized insoles

Intervention Type 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.

Interventions

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ESWT

will be given once a week, total 5 sessions ofESWT+ home exercises program

Intervention Type DEVICE

customized insoles

Will be given customized insoles+ home exercise program. Insoles will be used for 12 weeks.

Intervention Type DEVICE

combined ESWT and custtomized insoles

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.

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Home exercise program( strengthening, stretching exercises, frozen water bottle rolling) Home exercise program( strengthening, stretching exercises, frozen water bottle rolling) Home exercise program( strengthening, stretching exercises, frozen water bottle rolling)

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Okan Küçükakkaş, Doç

Role: STUDY_DIRECTOR

[email protected]

Nesrin Yılmaz Baıramov, MD

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Elif Uğurlu, MD

Role: STUDY_CHAIR

[email protected]

Locations

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Bezmialem Vakif University

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Mehmet Hakan Özdemir

Role: CONTACT

+902124530453

Okan Küçükakkaş, Doç

Role: CONTACT

+905064334436

Facility Contacts

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Mehmet Hakan Özdemir

Role: primary

+902124530453

References

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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.

Reference Type BACKGROUND
PMID: 31186388 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35964021 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16801514 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25941995 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25544167 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33233945 (View on PubMed)

Other Identifiers

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4.2019/10

Identifier Type: -

Identifier Source: org_study_id

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