Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298747
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2024-03-01
Brief Title:
Ultrasound-guided Selective Cervical Root Pulsed Radiofrequency Therapy in Patients With Cervical Radicular Pain
Sponsor:
Diskapi Teaching and Research Hospital
Organization:
Diskapi Teaching and Research Hospital
Study Overview
Official Title:
Evaluation of the Efficacy of Ultrasound-guided Selective Cervical Root Pulsed Radiofrequency Therapy in Patients With Cervical Radicular Pain Analysis of Single-Center Data
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
pulsedrf
Brief Summary:
Chronic cervical pain is a common disorder with a prevalence of approximately 35 in adults Cervical radicular pain is defined as radiating pain in the upper limb caused by compression or inflammation of the nerve roots ascending from the intervertebral foramen to the spinal cord due to disc herniation or spinal stenosis C7 and C6 are the two most commonly affected nerve roots Various treatment modalities are available including oral medications physiotherapy and epidural steroid injections However chronic and persistent pain that develops as a result of some patients not responding to these treatments Ultrasound-guided selective cervical nerve root block and pulsed radiofrequency are interventional treatments used in patients with radicular cervical pain unresponsive to conservative treatments Pulsed radiofrequency PRF treatment of peripheral nerves may provide long-term pain relief in patients with short-term pain relief with a local anesthetic block Studies have shown the effectiveness of PRF therapy applied to selective cervical nerve roots in relieving cervical radicular pain
Detailed Description:
Pulsed radiofrequency treatment applied to selective cervical nerve roots C5 C6 and C7 under ultrasound guidance is frequently used in patients with cervical radicular pain due to cervical disc herniation who do not respond adequately to medical treatment and physiotherapy
Pain intensity was evaluated at baseline and 13 and 6 months after US-guided selective cervical nerve root PRF treatment using VAS Visual analog scale The primary outcome measure was percent reduction in pain with 50 pain relief lasting at least 6 months was defined as a positive categorical outcome
Patients functionality and neuropathic pain status were assessed using the Neck Disability Index NDI and Douleur Neuropathique 4 Questions DN4 at baseline and 13 and 6 months after US-guided selective cervical nerve root PRF treatment respectively Secondary outcome measure was defined as a positive categorical outcome of 50 or more improvement in these scores for at least 6 months
In addition demographic data such as age years gender duration of pain months pain side right or left affected cervical nerve root level one or multiple levels and history of surgery for cervical disc herniation and analgesic use nonsteroidal anti-inflammatory drugs or opioids were obtained from patient data and retrospectively analyzed the patients electronic medical history records
The primary aim of this study was to determine the efficacy of US-SCNR PRF treatment and the clinical and demographic variables associated with treatment outcomes The secondary aim of this study was to determine the improvement in functionality and neuropathic pain status of patients after the procedure and treatment-related adverse events
Pain intensity was evaluated at baseline and 13 and 6 months after US-guided selective cervical nerve root PRF treatment using VAS Visual analog scale The primary outcome measure was percent reduction in pain with 50 pain relief lasting at least 6 months was defined as a positive categorical outcome
Patients functionality and neuropathic pain status were assessed using the Neck Disability Index NDI and Douleur Neuropathique 4 Questions DN4 at baseline and 13 and 6 months after US-guided selective cervical nerve root PRF treatment respectively Secondary outcome measure was defined as a positive categorical outcome of 50 or more improvement in these scores for at least 6 months
In addition demographic data such as age years gender duration of pain months pain side right or left affected cervical nerve root level one or multiple levels and history of surgery for cervical disc herniation and analgesic use nonsteroidal anti-inflammatory drugs or opioids were obtained from patient data and retrospectively analyzed the patients electronic medical history records
The primary aim of this study was to determine the efficacy of US-SCNR PRF treatment and the clinical and demographic variables associated with treatment outcomes The secondary aim of this study was to determine the improvement in functionality and neuropathic pain status of patients after the procedure and treatment-related adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None