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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)

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05885243
Acronym
eswt
Enrollment
48
Registered
2023-06-01
Start date
2023-03-01
Completion date
2023-06-15
Last updated
2023-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heel Pain Syndrome, Heel Spur, Heel Spur Syndrome

Keywords

heel spur, extracorporeal shock wave therapy, insole, customized insole

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.

Interventions

DEVICEESWT

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.

COMBINATION_PRODUCTcombined 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.

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog ScaleChange 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
American Orthopaedic Foot and Ankle Society (AOFAS) Pain SubscaleChange 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.
Foot Function Index Pain SubscaleChange 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.

Secondary

MeasureTime frameDescription
Roles and Maudsley ScoreChange 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
American Orthopaedic Foot and Ankle Society (AOFAS) ScoreChange 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.
Foot Function IndexChange 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactMehmet Hakan Özdemir
mozdemir@bezmialem.edu.tr+902124530453
Backup ContactOkan Küçükakkaş, Doç
okan4494@yahoo.com+905064334436

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026