Clinical trial NCT05032300: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Plantar Fasciitis
Keywords: extracorporeal shock wave
chronic plantar fasciitis
elastic modulus
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Test group (shock wave) chronic plantar fasciitis; Control group patients with chronic plantar fasciitis;
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Elastic modulus and morphology of plantar fascia lesion area
timeFrame: Up to six months
measure: Reduction in pain as assessed by a 0-10 visual analogue scale (VAS)
timeFrame: Up to six months
Secondary outcomes:
measure: American Society of Foot and Ankle Surgery (AOFAS) Ankle and Hindfoot Function Score
timeFrame: Up to six months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital ,Southern Medical University
state: Guangdong
Study officials:
References: