Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558552
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Neuromodulation and Posterior Tibial Nerve Randomized Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neuromodulation of the Posterior Tibial Nerve in the Heel Spur Epin Calcanei Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Heel pain is an important clinical condition that impairs patients quality of life and causes loss of workforce Heel spurs are one of the most important causes of heel pain Heel spur often plantar fascia calcaneus It is seen at the site of attachment to the tuberosity and is plantar It develops secondary to microtrauma to the calcaneus following inflammation of the fascia and over time an organized bone protrusion called a spur forms in the same area Plantar in patients with heel spurs It is often accompanied by fasciitis Heel spurs are more common in women It increases with increasing age due to mechanical trauma to the heel Its incidence is not clearly known In its etiology age gender obesity foot structure that disrupts biomechanics rheumatological and metabolic diseases and trauma come to the fore
Nonsteroids in the treatment of heel spurs There are treatment options such as anti-inflammatory drugs NSAIDs other analgesics exercise splints and orthoses shoe insoles and pads corticosteroid injections into the spur area and extracorporeal shock wave therapy ESWT There are a limited number of studies in which pulse radiofrequency PRF and injection were applied to the posterior tibial nerve which senses the region and conventional or pulse radiofrequency was successfully applied to the lesion area
ESWT is a non-invasive method A shock wave is created together with sound and pressure waves Changes at the cellular level with the shock wave include increased collagen production increased blood flow in the applied area acceleration of wound healing and cellular proliferation In ESWT radial and focal waves are applied depending on the tissue depth patellar tendinopathy plantar fasciitis myositis It is an effective and reliable method that is frequently used in the treatment of ossificans lateral epicondylitis iliotibial band syndrome many tendinopathies and heel spurs
PRF is a newer neuromodulation method than conventional radiofrequency It increases c-fos gene expression at the cellular level in neurons without causing destructive damage to the nerve and A-delta and C fibers are affected algogenic neuromediators decrease endogenous opioids such as Dynorphin Enkephalin and Endorphin increase thus reducing pain
Nonsteroids in the treatment of heel spurs There are treatment options such as anti-inflammatory drugs NSAIDs other analgesics exercise splints and orthoses shoe insoles and pads corticosteroid injections into the spur area and extracorporeal shock wave therapy ESWT There are a limited number of studies in which pulse radiofrequency PRF and injection were applied to the posterior tibial nerve which senses the region and conventional or pulse radiofrequency was successfully applied to the lesion area
ESWT is a non-invasive method A shock wave is created together with sound and pressure waves Changes at the cellular level with the shock wave include increased collagen production increased blood flow in the applied area acceleration of wound healing and cellular proliferation In ESWT radial and focal waves are applied depending on the tissue depth patellar tendinopathy plantar fasciitis myositis It is an effective and reliable method that is frequently used in the treatment of ossificans lateral epicondylitis iliotibial band syndrome many tendinopathies and heel spurs
PRF is a newer neuromodulation method than conventional radiofrequency It increases c-fos gene expression at the cellular level in neurons without causing destructive damage to the nerve and A-delta and C fibers are affected algogenic neuromediators decrease endogenous opioids such as Dynorphin Enkephalin and Endorphin increase thus reducing pain
Detailed Description:
The study will include 100 patients between the ages of 18 and 65 diagnosed with heel spurs who meet the inclusion and exclusion criteria in the Algology and PMR Physical medicine and rehabilitation departments of Kanuni Sultan Süleyman Training and Research Hospital between May 2024 and August 2024 Standard effect As a result of the power analysis it was deemed appropriate to include at least 22 cases in each group with a power of 80 and a margin of error of 084 According to this result a total of 100 patients will be included in the study taking into account the losses Randomization will be done using a randomization program to divide patients into two groups and assign a number to each patient
The power analysis it was deemed appropriate to include at least 22 cases in each group with a standard effect size of 084 with 80 power and 5 margin of error According to this result a total of 100 patients will be included in the study taking into account losses The posterior tibial nerve will be performed by the same algologist Patients will be monitored standardly Noninvasive blood pressure pulse oximeter electrocardiogram and will be performed in the supine position at TCPRF For TCPRF a 4598 mm diameter transcutaneous electrode FIAB SPA Italy will be used Electrode medial at ankle level It will be placed posterior to the malleolus in the posterior tibial nerve trace accompanying the artery after palpation of the posterior tibial artery TCPRF will be applied for 8 minutes at 80 volts 2 Hz 20 ms The process will be repeated 3 times with a one-week interval
To the control group with the radial ESWT device Vibrolith An Orto brand electro- pneumatic extracorporeal shock wave therapy device will be used It will be applied by the same physiotherapist with at least 10 years of experience in the field Sick It will be in the prone position and ESWT will be applied to the spur area as a radial type shock wave The process will be repeated 3 times with a one-week interval Sessions will be applied with 10 Hz frequency 2000 beats 25 bar intensity
Patient evaluation and results will be made by another algologist FAE who is unaware of the type of treatment Demographic data of the patients body mass index BMI symptom duration additional diseases medical treatments the side where the procedure was performed rest and activity Numeric Rating Scale -11 NRS and Foot function index Foot function index FFI will be recorded before the procedure and in the 1st and 3rd months after the procedure NRS-11 is an 11-point numerical scale in which patients can evaluate their pain between 0 no pain and 10 the most severe pain they have ever felt in their life FFI is a validated scale consisting of 23 questions in total including 3 subgroups pain disability and activity limitation
The power analysis it was deemed appropriate to include at least 22 cases in each group with a standard effect size of 084 with 80 power and 5 margin of error According to this result a total of 100 patients will be included in the study taking into account losses The posterior tibial nerve will be performed by the same algologist Patients will be monitored standardly Noninvasive blood pressure pulse oximeter electrocardiogram and will be performed in the supine position at TCPRF For TCPRF a 4598 mm diameter transcutaneous electrode FIAB SPA Italy will be used Electrode medial at ankle level It will be placed posterior to the malleolus in the posterior tibial nerve trace accompanying the artery after palpation of the posterior tibial artery TCPRF will be applied for 8 minutes at 80 volts 2 Hz 20 ms The process will be repeated 3 times with a one-week interval
To the control group with the radial ESWT device Vibrolith An Orto brand electro- pneumatic extracorporeal shock wave therapy device will be used It will be applied by the same physiotherapist with at least 10 years of experience in the field Sick It will be in the prone position and ESWT will be applied to the spur area as a radial type shock wave The process will be repeated 3 times with a one-week interval Sessions will be applied with 10 Hz frequency 2000 beats 25 bar intensity
Patient evaluation and results will be made by another algologist FAE who is unaware of the type of treatment Demographic data of the patients body mass index BMI symptom duration additional diseases medical treatments the side where the procedure was performed rest and activity Numeric Rating Scale -11 NRS and Foot function index Foot function index FFI will be recorded before the procedure and in the 1st and 3rd months after the procedure NRS-11 is an 11-point numerical scale in which patients can evaluate their pain between 0 no pain and 10 the most severe pain they have ever felt in their life FFI is a validated scale consisting of 23 questions in total including 3 subgroups pain disability and activity limitation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None