Shear Wave Elastography Technology to Evaluate the Efficacy of ESW in the Treatment of Patients With Chronic Plantar Fasciitis

Study Overview
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Brief Summary
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Inflammation of the plantar fascia is called plantar fasciitis and is common in active or overweight individuals. It can be treated conservatively or surgically. Extracorporeal shock wave therapy has shown significant efficacy in the treatment of plantar fasciitis. Repeated chronic inflammation of the plantar fascia may lead to fibrous edema, thickening and even calcification in the fascia, resulting in thickening of the plantar fascia in patients with chronic plantar fasciitis and affecting the mechanical properties of the plantar fascia (changes in elastic modulus) ). Previous studies rarely involved changes in the elasticity of the plantar fascia before and after extracorporeal shock wave treatment.

Official Title
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Shear Wave Elastography Technology to Evaluate the Efficacy of ESW in the Treatment of Patients With Chronic Plantar Fasciitis,a Single-blinded Randomised Controlled Trial

Conditions
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Chronic Plantar Fasciitis

Intervention / Treatment
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* Device: Focused shockwave
* Other: Home therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pain at the proximal calcaneal stop of the plantar fascia The pain is severe when waking up in the morning or standing and walking after sitting for a long time, and it is slightly relieved after activities, and it will be aggravated after long walking or standing for a long time Pain time> 3 months Visual Scoring Scale (VAS)>4 The pain is tingling, sore, or burning, etc There is or no tender point at the bottom of the arch of the foot The patient has not undergone corticosteroid injection therapy or shock wave therapy or surgery X-ray confirmed no calcaneal spurs The patient agrees to participate in this study Exclusion Criteria: Suffering from calcaneal stress fracture, atrophy of fat pad, compression of the little toe abductor nerve (Baxter's nerve), tarsal tunnel syndrome, sciatica, bone or soft tissue tumor, rheumatism or rheumatoid arthritis, rigidity Those with spondylitis and infection those who disagree with and do not understand the treatment methods or methods of the experiment those with mental disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Test group (shock wave) chronic plantar fasciitis; Control group patients with chronic plantar fasciitis;
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: focused shockwave therapy<br>Patients will receive 6 sessions of focused shockwave therapy. | Device: Focused shockwave<br>* Procedure: Focused shockwave therapy received shock wave therapy once a week: first locate, touch on the heel of the patient Tenderness points, take tenderness points as treatment points;Then ask the patient to take the lower limbs straight sitting or prone position, Target intensity will be within a range of 0.15-0.25 mJ/mm2 at maximum Hz, Total of 3000 pulses; rest for 20 minutes after the treatment<br>Other: Home therapy<br>* Stretching and ice massage<br>|
| Active Comparator: control<br>Patients in the control group will be treated using the home therapy protocol only. | Other: Home therapy<br>* Stretching and ice massage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elastic modulus and morphology of plantar fascia lesion area | Sonoelastographic changes of plantar fascia after ESWT | Up to six months | 
| Reduction in pain as assessed by a 0-10 visual analogue scale (VAS) | Patients can score a minimum of 0 and a maximum of 10. Getting a high score indicates a bad situation. | Up to six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Society of Foot and Ankle Surgery (AOFAS) Ankle and Hindfoot Function Score | The AOFAS assess pain, symptoms, activities of daily living, sports, and quality of life related to foot and ankle pain. This will be assessed on a scale of 0-100, where 100 indicates no problems and 0 indicates extreme problems. | Up to six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extracorporeal shock wave, chronic plantar fasciitis, elastic modulus