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)

May 23, 2023 updated by: Bezmialem Vakif University

Evaluation of the Efficiency of ESWT and Custom İnsoles Produced With Podometric Measurement in the Treatment of Painful Heel Spurs

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Bezmialem Vakif University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ESWT
Group 1 (n:16) will be given once a week, total 5 sessions of ESWT+ home exercise program
Device: ESWT
will be given once a week, total 5 sessions ofESWT+ home exercises program
Other Names:
  • Home exercise program( strengthening, stretching exercises, frozen water bottle rolling)
Experimental: customized insoles
Group 2 (n:16) will be given customized insoles+ home exercise program. Insoles will be used for 12 weeks.
Device: customized insoles
Will be given customized insoles+ home exercise program. Insoles will be used for 12 weeks.
Other Names:
  • Home exercise program( strengthening, stretching exercises, frozen water bottle rolling)
Experimental: 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.
Device: ESWT
will be given once a week, total 5 sessions ofESWT+ home exercises program
Other Names:
  • Home exercise program( strengthening, stretching exercises, frozen water bottle rolling)
Device: customized insoles
Will be given customized insoles+ home exercise program. Insoles will be used for 12 weeks.
Other Names:
  • Home exercise program( strengthening, stretching exercises, frozen water bottle rolling)
Combination product: 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.
Other Names:
  • Home exercise program( strengthening, stretching exercises, frozen water bottle rolling)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: Change from baseline at 12 weeks after treatment.
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
Time Frame: Change from baseline at 12 weeks after treatment.
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
Time Frame: Change from baseline at 12 weeks after treatment.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Roles and Maudsley Score
Time Frame: Change from baseline at 12 weeks after treatment.
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.
American Orthopaedic Foot and Ankle Society (AOFAS) Score
Time Frame: Change from baseline at 12 weeks after treatment.
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.
Foot Function Index
Time Frame: Change from baseline at 12 weeks after treatment.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

June 15, 2023

Study Completion (Estimated)

June 15, 2023

Study Registration Dates

First Submitted

May 23, 2023

First Submitted That Met QC Criteria

May 23, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4.2019/10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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