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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Plantar Fasciitis
• Intervention / Treatment: Other: Home therapy; Device: Focused shockwave

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: yonggang Dou, master; Phone Number: +8615013006491; Email: 2206387013@qq.com
• Study Contact Backup: Name: qiuyu Chen, Master; Phone Number: +8613380057831; Email: 168072468@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital ,Southern Medical University
      • Contact: yonggang Dou, master; Phone Number: +8615013006491; Email: 2206387013@qq.com
      • Principal Investigator: yonggang Dou, master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: focused shockwave therapy; Patients will receive 6 sessions of focused shockwave therapy.	Other: Home therapy; Stretching and ice massage; 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
Active Comparator: control; Patients in the control group will be treated using the home therapy protocol only.	Other: Home therapy; Stretching and ice massage

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: August 24, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: extracorporeal shock wave; chronic plantar fasciitis; elastic modulus
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: NFEC-202101-K9-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No