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

Sponsor
Nanfang Hospital of Southern Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05032300
Collaborator
(none)
60
1
2
25
2.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Focused shockwave
  • Other: Home therapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Test group (shock wave) chronic plantar fasciitis; Control group patients with chronic plantar fasciitis;Test group (shock wave) chronic plantar fasciitis; Control group patients with chronic plantar fasciitis;
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: focused shockwave therapy

Patients will receive 6 sessions of focused shockwave therapy.

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

Active Comparator: control

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

Other: Home therapy
Stretching and ice massage

Outcome Measures

Primary Outcome Measures

  1. Elastic modulus and morphology of plantar fascia lesion area [Up to six months]

    Sonoelastographic changes of plantar fascia after ESWT

  2. 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.

Secondary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nanfang Hospital ,Southern Medical University Guangzhou Guangdong China 510515

Sponsors and Collaborators

  • Nanfang Hospital of Southern Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yonggang Dou, Intermediate Physiotherapist, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT05032300
Other Study ID Numbers:
  • NFEC-202101-K9-01
First Posted:
Sep 2, 2021
Last Update Posted:
Sep 2, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yonggang Dou, Intermediate Physiotherapist, Nanfang Hospital of Southern Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 2, 2021