Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06240507 |
Other study ID # |
PTN PRF vs intralesional RFT |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 2, 2023 |
Est. completion date |
September 1, 2023 |
Study information
Verified date |
January 2024 |
Source |
Diskapi Teaching and Research Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This study aims to compare the efficacy of ultrasound (US)-guided posterior tibial nerve
pulsed radiofrequency (PTN PRF) and fluoroscopy (FL)-guided intralesional radiofrequency
thermocoagulation (RFT) for the treatment of painful calcaneal spur and plantar fasciitis
refractory to conservative treatments. For this evaluation, a numerical rating (NRS) and the
American Orthopedic Foot and Ankle Society (AOFAS) ankle hindfoot scores will be used before
and after both interventions.
Description:
Painful calcaneal spurs (PCS) and plantar fasciitis (PF) are common foot conditions affecting
approximately 10-15% of the population. These conditions can cause severe heel pain and
disability, affecting the patients' quality of life and productivity.
Treatment of these conditions is complex and sometimes resistant to conventional therapies,
such as rest, ice, stretching, orthotics, and anti-inflammatory drugs. Some studies have
shown that conservative treatments can improve PCS and PF symptoms within 12 months. However,
if conservative treatments fail, interventional procedures such as corticosteroid injections,
radiofrequency ablation, or surgery may be used on the PCS and surrounding nerves.
PRF and RFT are two modalities of thermal ablation that can be used to treat chronic pain
conditions. PRF delivers short bursts of high-voltage electrical current to the target nerve,
creating a non-thermal effect that modulates the transmission of pain signals. RFT delivers a
continuous current that heats the target tissue, causing coagulation, and can promote
thinning of hard tissues, such as calcaneal spurs and plantar fascia. The PTN is a branch of
the sciatic nerve that provides sensory and motor innervation to the heel and sole of the
foot, where calcaneal spurs and PF occur. The advantage of the PTN over its smaller branches
is that it can be visualized and targeted using US. FL can visualize PCS.
US-guided PTN PRF and FL-guided intralesional RFT for pain management in PCS and PF have been
used in a limited number of studies; however, no studies have compared their efficacy and
adverse event rates.
The primary aim of this study was to compare the efficacy of these two treatment modalities.
The secondary aim was to determine the incidence of adverse events associated with US-guided
PTN PRF and FL-guided intralesional TRF treatment. A total of at least 46 patients, 23
patients in each group, will be enrolled for comparison. NRS, and AOFAS scores before, 1
month, and 3 months after treatment will be compared both within and between groups.