Evaluation of the Efficiency of ESWT and Custom İnsoles Produced With Podometric Measurement in the Treatment of Painful Heel Spurs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Bezmialem Vakif University
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- American Orthopaedic Foot and Ankle Society (AOFAS) Pain Subscale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: customized insoles (Device)
ESWT
Group 1 (n:16) will be given once a week, total 5 sessions of ESWT+ home exercise program
Intervention: ESWT (Device)
customized insoles
Group 2 (n:16) will be given customized insoles+ home exercise program. Insoles will be used for 12 weeks.
Intervention: customized insoles (Device)
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.
Intervention: ESWT (Device)
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.
Intervention: combined ESWT and custtomized insoles (Combination Product)
Outcomes
Primary Outcomes
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.
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
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.
Secondary Outcomes
- Roles and Maudsley Score(Change from baseline at 12 weeks after treatment.)
- Foot Function Index(Change from baseline at 12 weeks after treatment.)
- American Orthopaedic Foot and Ankle Society (AOFAS) Score(Change from baseline at 12 weeks after treatment.)