Clinical trial NCT05342207: Endoscopic Plantar Fascia Release in Cases of Chronic Resistant Plantar Fasciopathy
Official title: Endoscopic Plantar Fascia Release in Cases of Chronic Resistant Plantar Fasciopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: in Cases of Chronic Resistant Plantar Fasciopathy
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The plantar fascia is a thick tissue band that connects the heel bone (the medial tubercle of the under surface of the calcaneus) to the metatarsophalangeal joints, forming the medial arch of the foot, which supports the foot during walking. Irritation and scarring of the plantar fascia is one of the most common causes of heel pain .

Plantar fasciopathy accounts for 11% to 15% of all foot disorders in both athletes and sedentary patients .

Although commonly referred to using incorrect nomenclature as plantar fasciitis ,it is degenerative process (i.e. fasciopathy).The etiology of plantar fasciopathy is not clear. It can result from irritation due to overstrain of the fascia, which induces mucoid degeneration The pathologic ﬁndings include degenerative tissue changes without inﬂammatory mediators .

The diagnosis of plantar fasciopathy is determined by the medical history and physical examination ﬁndings. Typically, patients present with heel pain during weight bearing , especially in the early morning and with the ﬁrst steps after a period of inactivity .

Patients will usually have tenderness around the site of the plantar aponeurosis . The pain can be reproduced by stretching the diseased plantar aponeurosis by passive hyperextension of the metatarsophalangeal joints .

Endoscopic plantar fasciotomy is a relatively new procedure, involves an endoscopic approach to the heel, allowing a plantar aponeurosis release to be performed with delicate instruments, minimal dissection, and immediate weight bearing


Eligibility criteria: Inclusion Criteria:

* Adults more than 18 years old presented by a single site heel pain with local pressure at the origin of plantar fascia on the medial Calcaneal tuberosity for one year, with failure of at least two lines of conservative treatment including:

Non-steroidal anti-inflammatory drugs (NSAIDs), Corticosteroid injections, physical therapy, exercise program (Achilles tendon and plantar fascia stretching exercises) and orthotic devices (heel cup, molded shoe insert or night splint) for at least 3 months.

Exclusion Criteria:

* Patients younger than 18 years.
* Patients who had a local infection or a metabolic disorder especially diabetes, generalized polyarthritis, sero-negative arthropathy, , tarsal tunnel syndrome.
* Patients with congenital anomalies e.g pesplanus, pescavus, limb length discrepancy, in-toeing, neuro-muscular disorders.
* Patients with an ipsilateral or contralateral vascular or neurological abnormalities, or malignancies.
* Recent trauma or foot and ankle deformity or fractures.
* Active anticoagulation therapy or bleeding disorders
* Patients who received a corticosteroid injection within the previous four weeks.

Primary outcomes:
measure: American Orthopedic Foot and Ankle-Hind foot Scale
timeFrame: 6 months following operation
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Cottom JM, Maker JM, Richardson P, Baker JS. Endoscopic Debridement for Treatment of Chronic Plantar Fasciitis: An Innovative Technique and Prospective Study of 46 Consecutive Patients. J Foot Ankle Surg. 2016 Jul-Aug;55(4):748-52. doi: 10.1053/j.jfas.2016.02.005. Epub 2016 Apr 5.
citation: Lui TH. Endoscopic Decompression of the First Branch of the Lateral Plantar Nerve and Release of the Plantar Aponeurosis for Chronic Heel Pain. Arthrosc Tech. 2016 Jun 6;5(3):e589-94. doi: 10.1016/j.eats.2016.02.018. eCollection 2016 Jun.
citation: Oliva F, Piccirilli E, Berardi AC, Frizziero A, Tarantino U, Maffulli N. Hormones and tendinopathies: the current evidence. Br Med Bull. 2016 Mar;117(1):39-58. doi: 10.1093/bmb/ldv054. Epub 2016 Jan 19.
citation: Sabir N, Demirlenk S, Yagci B, Karabulut N, Cubukcu S. Clinical utility of sonography in diagnosing plantar fasciitis. J Ultrasound Med. 2005 Aug;24(8):1041-8. doi: 10.7863/jum.2005.24.8.1041.