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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)

Primary Purpose

Heel Spur, Heel Spur Syndrome, Heel Pain Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ESWT
customized insoles
combined ESWT and custtomized insoles
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heel Spur focused on measuring heel spur, extracorporeal shock wave therapy, insole, customized insole

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bezmialem Vakif UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

ESWT

customized insoles

combined ESWT and customized insoles

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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
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.
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.

Secondary Outcome Measures

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
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.
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.

Full Information

First Posted
May 23, 2023
Last Updated
May 23, 2023
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT05885243
Brief Title
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)
Acronym
eswt
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
June 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heel Spur, Heel Spur Syndrome, Heel Pain Syndrome
Keywords
heel spur, extracorporeal shock wave therapy, insole, customized insole

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ESWT
Arm Type
Experimental
Arm Description
Group 1 (n:16) will be given once a week, total 5 sessions of ESWT+ home exercise program
Arm Title
customized insoles
Arm Type
Experimental
Arm Description
Group 2 (n:16) will be given customized insoles+ home exercise program. Insoles will be used for 12 weeks.
Arm Title
combined ESWT and customized insoles
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ESWT
Other Intervention Name(s)
Home exercise program( strengthening, stretching exercises, frozen water bottle rolling)
Intervention Description
will be given once a week, total 5 sessions ofESWT+ home exercises program
Intervention Type
Device
Intervention Name(s)
customized insoles
Other Intervention Name(s)
Home exercise program( strengthening, stretching exercises, frozen water bottle rolling)
Intervention Description
Will be given customized insoles+ home exercise program. Insoles will be used for 12 weeks.
Intervention Type
Combination Product
Intervention Name(s)
combined ESWT and custtomized insoles
Other Intervention Name(s)
Home exercise program( strengthening, stretching exercises, frozen water bottle rolling)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
The self-evaluation of pain severity during rest, stretching and pressing on the medial calcaneal tubercle was calculated using a 10 cm VAS scale
Time Frame
Change from baseline at 12 weeks after treatment.
Title
American Orthopaedic Foot and Ankle Society (AOFAS) Pain Subscale
Description
AOFAS scale includes three subscales (pain, function and alignment). Pain consists of one item with a maximal score of 40 points, indicating no pain.
Time Frame
Change from baseline at 12 weeks after treatment.
Title
Foot Function Index Pain Subscale
Description
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.
Time Frame
Change from baseline at 12 weeks after treatment.
Secondary Outcome Measure Information:
Title
Roles and Maudsley Score
Description
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
Time Frame
Change from baseline at 12 weeks after treatment.
Title
American Orthopaedic Foot and Ankle Society (AOFAS) Score
Description
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.
Time Frame
Change from baseline at 12 weeks after treatment.
Title
Foot Function Index
Description
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.
Time Frame
Change from baseline at 12 weeks after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mehmet Hakan Özdemir
Phone
+902124530453
Email
mozdemir@bezmialem.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Okan Küçükakkaş, Doç
Phone
+905064334436
Email
okan4494@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Okan Küçükakkaş, Doç
Organizational Affiliation
okan4494@yahoo.com
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nesrin Yılmaz Baıramov, MD
Organizational Affiliation
nsrn.ylmz@yahoo.com
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elif Uğurlu, MD
Organizational Affiliation
elifdemirbag92@gmail.com
Official's Role
Study Chair
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehmet Hakan Özdemir
Phone
+902124530453
Email
mozdemir@bezmialem.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25941995
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.
Results Reference
background
PubMed Identifier
25544167
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.
Results Reference
background
PubMed Identifier
33233945
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.
Results Reference
background
PubMed Identifier
31186388
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.
Results Reference
background
PubMed Identifier
35964021
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.
Results Reference
background
PubMed Identifier
16801514
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.
Results Reference
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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)

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