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

Not Applicable

• Conditions: Chronic Plantar Fasciitis
• Interventions: Device: Focused shockwave; Other: Home therapy

• Registration Number: NCT05032300
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-24
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-01
• Last Update Submitted: 2021-09-01
• Study First Posted: 2021-09-02
• Last Update Posted: 2021-09-02
• Study Start: 2021-11
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Pain at the proximal calcaneal stop of the plantar fascia
2. 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
3. Pain time> 3 months
4. Visual Scoring Scale (VAS)>4
5. The pain is tingling, sore, or burning, etc
6. There is or no tender point at the bottom of the arch of the foot
7. The patient has not undergone corticosteroid injection therapy or shock wave therapy or surgery
8. X-ray confirmed no calcaneal spurs
9. The patient agrees to participate in this study

Exclusion Criteria

1. 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
2. those who disagree with and do not understand the treatment methods or methods of the experiment
3. those with mental disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
focused shockwave therapy	Home therapy	Patients will receive 6 sessions of focused shockwave therapy.
control	Home therapy	Patients in the control group will be treated using the home therapy protocol only.
focused shockwave therapy	Focused shockwave	Patients will receive 6 sessions of focused shockwave therapy.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
American Society of Foot and Ankle Surgery (AOFAS) Ankle and Hindfoot Function Score	Up to six months	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.

Trial Locations

Locations (1)

Nanfang Hospital ,Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China