in Cases of Chronic Resistant Plantar FasciopathyNCT05342207
Endoscopic Plantar Fascia Release in Cases of Chronic Resistant Plantar Fasciopathy
A study testing Endoscopic plantar fascia release in cases of chronic resistant plantar fasciopathy in people with in Cases of Chronic Resistant Plantar Fasciopathy, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- in Cases of Chronic Resistant Plantar Fasciopathy
- What is being tested?
- Endoscopic plantar fascia release in cases of chronic resistant plantar fasciopathy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2022to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hassan H Noaman, professor contact
About this study
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 .
Read more
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
- Being tested
- Endoscopic plantar fascia release in cases of chronic resistant plantar fasciopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic plantar fascia release in cases of chronic resistant plantar fasciopathyProcedure or surgery
A medial portal will be developed 1cm away from the plantar skin along a vertical line passing through the posterior border of the medial malleolus with the foot in neutral position. A 5 mm cannula will be then introduced through the lateral portal over the trocar. Irrigation fluid will be then connected. A 30-degree 4.0 mm endoscope will be inserted inside the cannula. A 4.5 motorized incisor blade will be then used to debride the subcutaneous tissue until full visualization of the shiny fibers of the plantar fascia will be possible. A needle was inserted vertically through the heel skin to act as a land mark for the middle of the plantar fascia. A scalpel blade will then introduced through the medial portal to divide the full thickness of the medial half of the plantar fascia into two leaflets under direct visualization . The posterior leaflet will be then totally debrided using a motorized incisor blade . The tunnel will then be irrigated and stitches will be done.
| Study group | Role | What they receive |
|---|---|---|
| cases | Experimental | Not described Receives: Procedure: Endoscopic plantar fascia release in cases of chronic resistant plantar fasciopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Orthopedic Foot and Ankle-Hind foot Scale
- Pain
- Function
- Alignment assessment
Measured: 6 months following operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for in Cases of Chronic Resistant Plantar FasciopathyStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Saeed Hamdy, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342207
- Sponsor's protocol ID
- Soh-Med-22-03-06
- Status last verified
- Apr 2022
- First submitted
- 16 Mar 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 27066869Lui 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.
PubMed 27656382Oliva 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.
PubMed 26790696Sabir 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.
PubMed 16040817
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Plantar Fascia Release in Cases of Chronic Resistant Plantar Fasciopathy
- ClinicalTrials.gov ID
- NCT05342207
- Acronym / sponsor ID
- Soh-Med-22-03-06
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cases | Experimental | Procedure: Endoscopic plantar fascia release in cases of chronic resistant plantar fasciopathy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic plantar fascia release in cases of chronic resistant plantar fasciopathyA medial portal will be developed 1cm away from the plantar skin along a vertical line passing through the posterior border of the medial malleolus with the foot in neutral position. A 5 mm cannula will be then introduced through the lateral portal over the trocar. Irrigation fluid will be then connected. A 30-degree 4.0 mm endoscope will be inserted inside the cannula. A 4.5 motorized incisor blade will be then used to debride the subcutaneous tissue until full visualization of the shiny fibers of the plantar fascia will be possible. A needle was inserted vertically through the heel skin to act as a land mark for the middle of the plantar fascia. A scalpel blade will then introduced through the medial portal to divide the full thickness of the medial half of the plantar fascia into two leaflets under direct visualization . The posterior leaflet will be then totally debrided using a motorized incisor blade . The tunnel will then be irrigated and stitches will be done. | Procedure or surgery | cases |
Primary outcome
American Orthopedic Foot and Ankle-Hind foot Scale
Time frame: 6 months following operation
* Pain * Function * Alignment assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Background: PubMed 27066869Cottom 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.
- Background: PubMed 27656382Lui 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.
- Background: PubMed 26790696Oliva 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.
- Background: PubMed 16040817Sabir 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.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan H Noaman, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic plantar fascia release in cases of chronic resistant plantar fasciopathy in people with in Cases of Chronic Resistant Plantar Fasciopathy, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed S Hamdy, resident (01025145663, mohamed011155@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Orthopedic Foot and Ankle-Hind foot Scale (time frame: 6 months following operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05342207, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.