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)

Heel Pain Syndrome Clinical Trial

— eswt  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05885243
• Other study ID #: 4.2019/10
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: June 15, 2023

Study information

• Verified date: May 2023
• Source: Bezmialem Vakif University
• Contact: Mehmet Hakan Özdemir
• Phone: +902124530453
• Email: mozdemir[@]bezmialem.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fasciitis, Plantar
• Heel Pain Syndrome
• Heel Spur
• Syndrome

Intervention

Device:
• ESWT
will be given once a week, total 5 sessions ofESWT+ home exercises program
• customized insoles
Will be given customized insoles+ home exercise program. Insoles will be used for 12 weeks.

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.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline at 12 weeks after treatment.
Primary	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.	Change from baseline at 12 weeks after treatment.
Primary	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.	Change from baseline at 12 weeks after treatment.
Secondary	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	Change from baseline at 12 weeks after treatment.
Secondary	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.	Change from baseline at 12 weeks after treatment.
Secondary	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.	Change from baseline at 12 weeks after treatment.