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

NCT05032300 | Unknown

• 1 other identifier: NFEC-202101-K9-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Plantar Fasciitis

Keywords

extracorporeal shock wave; chronic plantar fasciitis; elastic modulus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• American Society of Foot and Ankle Surgery (AOFAS) Ankle and Hindfoot Function Score

  Up to six months

Study Arms (2)

focused shockwave therapy

ACTIVE COMPARATOR

Patients will receive 6 sessions of focused shockwave therapy.

Device: Focused shockwave; Other: Home therapy

control

ACTIVE COMPARATOR

Patients in the control group will be treated using the home therapy protocol only.

Other: Home therapy

Interventions

Focused shockwave DEVICE

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

focused shockwave therapy

Home therapy OTHER

Stretching and ice massage

control; focused shockwave therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital ,Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Home Infusion Therapy

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Home Care Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

yonggang Dou, Master

CONTACT

+8615013006491; 2206387013@qq.com

qiuyu Chen, Master

CONTACT

+8613380057831; 168072468@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intermediate Physiotherapist

Model Details: Test group (shock wave) chronic plantar fasciitis; Control group patients with chronic plantar fasciitis;

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 2, 2021
• Study Start: November 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 2, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)