Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524531
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Pulsed RF Neuromodulation and Leukocyte-Rich PRP for Refractory Low Back Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Efficacy of Pulsed RF Neuromodulation and Leukocyte-Rich PRP for the Treatment of Refractory Low Back Pain Due to Multifidus Dysfunction
Status:
RECRUITING
Status Verified Date:
2024-07
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:
Multifidus
Brief Summary:
This clinical trial aims to check the safety and efficacy profile of pulsed radiofrequency RF neuromodulation combined with leukocyte-rich platelet-rich plasma PRP injections for the treatment of refractory low back pain due to multifidus dysfunction The trial will compare two groups one receiving standard physical therapy and the other receiving pulsed RF neuromodulation and physiotherapy
Detailed Description:
Low back pain is a common condition often associated with multifidus muscle dysfunction which can result from aging obesity or limited movement This dysfunction is characterized by fatty infiltration and loss of muscle function Surgical procedures involving posterior or transpedicular screw insertion can exacerbate this issue by damaging the multifidus muscle leading to persistent pain
This study will investigate the effects of pulsed RF neuromodulation on the L2 and L3 segments bilaterally with each side receiving treatment for 6 minutes In addition leukocyte-rich PRP will be injected into the multifidus muscle and patients will undergo a physiotherapy regimen The primary outcomes will be compared with those of a control group receiving only physical therapy
This study will investigate the effects of pulsed RF neuromodulation on the L2 and L3 segments bilaterally with each side receiving treatment for 6 minutes In addition leukocyte-rich PRP will be injected into the multifidus muscle and patients will undergo a physiotherapy regimen The primary outcomes will be compared with those of a control group receiving only physical therapy
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