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Heel SpureswtNCT05885243

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)

A study testing ESWT, customized insoles and combined ESWT and custtomized insoles in people with Heel Spur and Heel Spur Syndrome, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Heel Spur, Heel Spur Syndrome, Heel Pain Syndrome
What is being tested?
ESWT, customized insoles and combined ESWT and custtomized insoles
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2023to 15 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged between 18-65 years
  • Pain in the heel for at least 3 weeks
  • Confirmation of the diagnosis with lateral foot radiography

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Mehmet Hakan Özdemir contact

+902124530453

mozdemir@bezmialem.edu.tr

Okan Küçükakkaş, Doç contact

+905064334436

okan4494@yahoo.com

Turkey (Türkiye)1 site, 1 recruiting

  • Bezmialem Vakif University

    Istanbul

    Mehmet Hakan Özdemir, +902124530453, mozdemir@bezmialem.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
ESWT, customized insoles, combined ESWT and custtomized insoles
Keywords
heel spur, extracorporeal shock wave therapy, insole, customized insole
Medical subject headings
Heel Spur, Fasciitis, Plantar

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ESWTDevice

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

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

  • customized insolesDevice

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

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

  • combined ESWT and custtomized insolesCombination product

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

    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.

Study groups in NCT05885243
Study groupRoleWhat they receive
ESWTExperimentalGroup 1 (n:16) will be given once a week, total 5 sessions of ESWT+ home exercise program
Receives: Device: ESWT
customized insolesExperimentalGroup 2 (n:16) will be given customized insoles+ home exercise program. Insoles will be used for 12 weeks.
Receives: Device: customized insoles
combined ESWT and customized insolesExperimentalGroup 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.
Receives: Device: ESWT; Device: customized insoles; Combination Product: combined ESWT and custtomized insoles

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Change from baseline at 12 weeks after treatment.

  2. 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.

    Measured: Change from baseline at 12 weeks after treatment.

  3. 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.

    Measured: Change from baseline at 12 weeks after treatment.

Secondary outcomes (3)

  1. 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

    Measured: Change from baseline at 12 weeks after treatment.

  2. 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.

    Measured: Change from baseline at 12 weeks after treatment.

  3. 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.

    Measured: Change from baseline at 12 weeks after treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2023
  2. Study start1 Mar 2023
  3. Primary completion15 Jun 2023 (estimated)
  4. Study completion15 Jun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05885243
Sponsor's protocol ID
4.2019/10
Acronym
eswt
Status last verified
May 2023
First submitted
23 May 2023
Last updated
1 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25941995

  • 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.

    PubMed 25544167

  • 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.

    PubMed 33233945

  • 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.

    PubMed 31186388

  • 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.

    PubMed 35964021

  • 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.

    PubMed 16801514

Questions about this trial

What is this clinical trial studying?

A study testing ESWT, customized insoles and combined ESWT and custtomized insoles in people with Heel Spur and Heel Spur Syndrome, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mehmet Hakan Özdemir (+902124530453, mozdemir@bezmialem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (time frame: Change from baseline at 12 weeks after treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05885243, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.

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