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

Chronic Plantar Fasciitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05032300
• Other study ID #: NFEC-202101-K9-01
• Status: Recruiting
• Phase: N/A
• Start date: November 2021
• Est. completion date: December 2023

Study information

• Verified date: September 2021
• Source: Nanfang Hospital of Southern Medical University
• Contact: yonggang Dou, Master
• Phone: +8615013006491
• Email: 2206387013[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Plantar Fasciitis
• Fasciitis
• Fasciitis, Plantar

Intervention

Device:
• Focused shockwave
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

Other:
• Home therapy
Stretching and ice massage

Locations

Country	Name	City	State
China	Nanfang Hospital ,Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elastic modulus and morphology of plantar fascia lesion area	Sonoelastographic changes of plantar fascia after ESWT	Up to six months
Primary	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	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