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

Primary Purpose

Chronic Plantar Fasciitis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Focused shockwave
Home therapy
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Plantar Fasciitis focused on measuring extracorporeal shock wave, chronic plantar fasciitis, elastic modulus

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nanfang Hospital ,Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

focused shockwave therapy

control

Arm Description

Patients will receive 6 sessions of focused shockwave therapy.

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

Outcomes

Primary Outcome Measures

Elastic modulus and morphology of plantar fascia lesion area
Sonoelastographic changes of plantar fascia after ESWT
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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 24, 2021
Last Updated
September 1, 2021
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05032300
Brief Title
Shear Wave Elastography Technology to Evaluate the Efficacy of ESW in the Treatment of Patients With Chronic Plantar Fasciitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 2021 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plantar Fasciitis
Keywords
extracorporeal shock wave, chronic plantar fasciitis, elastic modulus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Test group (shock wave) chronic plantar fasciitis; Control group patients with chronic plantar fasciitis;
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
focused shockwave therapy
Arm Type
Active Comparator
Arm Description
Patients will receive 6 sessions of focused shockwave therapy.
Arm Title
control
Arm Type
Active Comparator
Arm Description
Patients in the control group will be treated using the home therapy protocol only.
Intervention Type
Device
Intervention Name(s)
Focused shockwave
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Home therapy
Intervention Description
Stretching and ice massage
Primary Outcome Measure Information:
Title
Elastic modulus and morphology of plantar fascia lesion area
Description
Sonoelastographic changes of plantar fascia after ESWT
Time Frame
Up to six months
Title
Reduction in pain as assessed by a 0-10 visual analogue scale (VAS)
Description
Patients can score a minimum of 0 and a maximum of 10. Getting a high score indicates a bad situation.
Time Frame
Up to six months
Secondary Outcome Measure Information:
Title
American Society of Foot and Ankle Surgery (AOFAS) Ankle and Hindfoot Function Score
Description
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.
Time Frame
Up to six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yonggang Dou, Master
Phone
+8615013006491
Email
2206387013@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
qiuyu Chen, Master
Phone
+8613380057831
Email
168072468@qq.com
Facility Information:
Facility Name
Nanfang Hospital ,Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yonggang Dou, master
Phone
+8615013006491
Email
2206387013@qq.com
First Name & Middle Initial & Last Name & Degree
yonggang Dou, master

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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