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)

Bezmialem Vakif University

Status: Enrolling

Conditions: Heel Pain Syndrome; Heel Spur; Heel Spur Syndrome

Treatments: Device: customized insoles; Device: ESWT; Combination Product: combined ESWT and custtomized insoles

Study type: Interventional

Funder types: Other

Identifiers

NCT05885243

4.2019/10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 3 patient groups

ESWT

Experimental group

Description:

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

Treatment:

Device: ESWT

customized insoles

Experimental group

Description:

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

Treatment:

Device: customized insoles

combined ESWT and customized insoles

Experimental group

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.

Treatment:

Combination Product: combined ESWT and custtomized insoles

Device: ESWT

Device: customized insoles