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Pulsed Radiofrequency in Chronic Lumbosacral Radicular Pain

Primary Purpose

Lumbar Radiculopathy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulsed radiofrequency on lumbar dorsal root ganglion
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Radiculopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: More than 18 years old Radiating Leg pain (with or without low back pain) Unresponsiveness or partial response to oral medications, physical therapy Confirmed by clinical examination and lasting for > 6 months with preoperative Numeric Rating Scales (NRS) score more than 4 Clinical presentation confirmed by Magnetic resonance imaging showing neural compression. Exclusion Criteria: Blood coagulopathies Infection at the site of puncture, History of mental disorder History of drug abuse MRI not consistent with clinical symptoms Radiculopathies with significant motor deficits requiring urgent surgery (e.g., Cauda Equina syndrome). Patients affected by central neurological impairment or peripheral distal neuropathies in the lower limbs.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    standard voltage group

    high voltage group

    Arm Description

    The Standard voltage group will be given a onetime pulsed radiofrequency (PRF) therapy. All subjects in this group will be given radiofrequency therapy on the dorsal root ganglion using the same tools and procedures by the same operator. Pulsed RF mode of RF generator will be used with following parameters --Temperature 42°C -- Frequency 2 Hertz - Pulse Width 20msec-Amplitude output voltage 45 Volt for Duration of 480sec done in 2 cycles.

    The High voltage group will be given a onetime pulsed radiofrequency (PRF) therapy. All subjects in this group will be given radiofrequency therapy on the dorsal root ganglion using the same tools and procedures by the same operator. Pulsed RF mode of RF generator will be used with following parameters --Temperature 42°C -- Frequency 2 Hertz - Pulse Width 20msec-Amplitude output voltage will be gradually increased to reach the highest voltage for each patient (55-75 Volt) for Duration of 480sec done in 2 cycles.

    Outcomes

    Primary Outcome Measures

    Numeric rating scale
    Numeric scale used to evaluate pain severity with 0 as the lowest score (no pain at all) and 10 as the highest score (most serious pain beyond endurance)

    Secondary Outcome Measures

    Oswestry low back disability questionnaire
    Questionnaire composed of ten questions and for each question, there is a possible points; 0 for the first answer, 1 for the second answer, etc. Score 0-4 : No disability Score 5-14 : Mild disability Score 15-24 : Moderate disability Score 25-34 : Severe disability Score 35-50 : Completely disabled

    Full Information

    First Posted
    January 24, 2023
    Last Updated
    February 2, 2023
    Sponsor
    Alexandria University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05713032
    Brief Title
    Pulsed Radiofrequency in Chronic Lumbosacral Radicular Pain
    Official Title
    High-voltage Fluoroscopic Guided Pulsed Radiofrequency in Comparison With Standard-voltage Pulsed Radiofrequency on Dorsal Root Ganglion in Chronic Lumbosacral Radicular Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2023 (Anticipated)
    Study Completion Date
    November 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Alexandria University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To evaluate the efficacy of usage of High-voltage pulsed radiofrequency on DRG in comparison to standard-voltage pulsed radiofrequency intervention in patients with chronic lumbosacral radicular pain
    Detailed Description
    Lumbosacral radicular (LRS) pain is one of the most common health care problem. Up to 5% of the population older than 30 years of age suffer low back pain radiating into the leg, making it probably the most commonly occurring form of neuropathic pain. Radicular pain has been discerned as the pain arising in a limb or trunk which is caused by ectopic activation of nociceptive afferent fibers in a spinal nerve or its roots or other neuropathic mechanisms. More accurately, radicular pain is a term applied to describe pain that results from the stimulation of, or a disorder of, a nerve root. Acute lumbosacral radicular pain, caused by disc herniation, improves considerably in the short-term. About three quarters of patients will have symptoms of recovery within 3 months; however, there is a high recurrence rate, and when pain persists after this period the prognosis is rather unfavorable, especially in the female population. Conservative therapy (pharmacotherapy or physiotherapy) is effective in 60% of cases, while the rest of cases progress into chronic pain. This results in a high degree of disability and ending with higher medical expenses. Patients suffering lumbosacral radicular pain often experience a reduced functionality leading to incapacity to work. A quarter of patients are still out of work 2 years after onset. Despite its high prevalence and significant impact on quality of life, the optimal conservative treatment for patients with radicular pain is not known. Considering the moderate quality of published evidence, the efficacy and tolerability of pharmacological treatment in primary care for patients with lumbosacral radicular pain is unclear. In the DRG, there is a process that takes place after being compressed by disc prolapse where a cascade of events within the DRG and upstream within the dorsal horn (DH) of the spinal cord leads to constitutive release of cytokines, production of abnormal ion channels, abnormal ion currents, early and late gene changes, and the development of chronic neuropathic pain. With this knowledge regarding the role of DRG neurons and non-neuronal cells within the DRG in the genesis of neuropathic pain, pharmacologic agents such as tetrodotoxin and non-pharmacologic treatments for neuropathic pain including electrical stimulation (neuromodulation) therapies targeting the DRG have been or are being developed. Pulsed radiofrequency (PRF) is a therapeutic strategy that has been used by pain practitioners as a non- or minimally autodestructive technique in which short bursts of high-frequency current are applied to nervous tissue. PRF is delivered in a pulse of 20 ms followed by a silent period of 480 ms to avoid radiofrequency heat lesions, and Pulsed radiofrequency (PRF) treatment uses high-frequency current intermittently and its use adjacent to the dorsal root ganglion (DRG) has been suggested for the treatment of radicular pain. It was previously demonstrated in other studies that the therapeutic effectiveness of PRF is affected by its parameters and the high-voltage PRF has been promising to enhance the clinical therapeutic effectiveness significantly for patients with neuralgia

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lumbar Radiculopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    96 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    standard voltage group
    Arm Type
    Active Comparator
    Arm Description
    The Standard voltage group will be given a onetime pulsed radiofrequency (PRF) therapy. All subjects in this group will be given radiofrequency therapy on the dorsal root ganglion using the same tools and procedures by the same operator. Pulsed RF mode of RF generator will be used with following parameters --Temperature 42°C -- Frequency 2 Hertz - Pulse Width 20msec-Amplitude output voltage 45 Volt for Duration of 480sec done in 2 cycles.
    Arm Title
    high voltage group
    Arm Type
    Active Comparator
    Arm Description
    The High voltage group will be given a onetime pulsed radiofrequency (PRF) therapy. All subjects in this group will be given radiofrequency therapy on the dorsal root ganglion using the same tools and procedures by the same operator. Pulsed RF mode of RF generator will be used with following parameters --Temperature 42°C -- Frequency 2 Hertz - Pulse Width 20msec-Amplitude output voltage will be gradually increased to reach the highest voltage for each patient (55-75 Volt) for Duration of 480sec done in 2 cycles.
    Intervention Type
    Procedure
    Intervention Name(s)
    Pulsed radiofrequency on lumbar dorsal root ganglion
    Intervention Description
    voltage of pulsed radiofrequency on DRG
    Primary Outcome Measure Information:
    Title
    Numeric rating scale
    Description
    Numeric scale used to evaluate pain severity with 0 as the lowest score (no pain at all) and 10 as the highest score (most serious pain beyond endurance)
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Oswestry low back disability questionnaire
    Description
    Questionnaire composed of ten questions and for each question, there is a possible points; 0 for the first answer, 1 for the second answer, etc. Score 0-4 : No disability Score 5-14 : Mild disability Score 15-24 : Moderate disability Score 25-34 : Severe disability Score 35-50 : Completely disabled
    Time Frame
    6 months
    Other Pre-specified Outcome Measures:
    Title
    Record of Complications intra or post-intervention
    Description
    as infection (eg; Epidural abscess , diskitis ) , bleeding , dural puncture and nerve injury
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: More than 18 years old Radiating Leg pain (with or without low back pain) Unresponsiveness or partial response to oral medications, physical therapy Confirmed by clinical examination and lasting for > 6 months with preoperative Numeric Rating Scales (NRS) score more than 4 Clinical presentation confirmed by Magnetic resonance imaging showing neural compression. Exclusion Criteria: Blood coagulopathies Infection at the site of puncture, History of mental disorder History of drug abuse MRI not consistent with clinical symptoms Radiculopathies with significant motor deficits requiring urgent surgery (e.g., Cauda Equina syndrome). Patients affected by central neurological impairment or peripheral distal neuropathies in the lower limbs.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mina N Habib
    Phone
    00201227417346
    Email
    mina-habib@live.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sahar A Elkaradawy, professor
    Organizational Affiliation
    yes
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Mohamed H Ellakany, professor
    Organizational Affiliation
    yes
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34265792
    Citation
    Cohen SP, Greuber E, Vought K, Lissin D. Safety of Epidural Steroid Injections for Lumbosacral Radicular Pain: Unmet Medical Need. Clin J Pain. 2021 Sep 1;37(9):707-717. doi: 10.1097/AJP.0000000000000963.
    Results Reference
    result
    PubMed Identifier
    24641192
    Citation
    Krames ES. The role of the dorsal root ganglion in the development of neuropathic pain. Pain Med. 2014 Oct;15(10):1669-85. doi: 10.1111/pme.12413. Epub 2014 Mar 18.
    Results Reference
    result
    PubMed Identifier
    29983585
    Citation
    Kim SJ, Park SJ, Yoon DM, Yoon KB, Kim SH. Predictors of the analgesic efficacy of pulsed radiofrequency treatment in patients with chronic lumbosacral radicular pain: a retrospective observational study. J Pain Res. 2018 Jun 26;11:1223-1230. doi: 10.2147/JPR.S164414. eCollection 2018.
    Results Reference
    result
    PubMed Identifier
    29565952
    Citation
    Lee DG, Cho YW, Ahn SH, Chang MC. The Effect of Bipolar Pulsed Radiofrequency Treatment on Chronic Lumbosacral Radicular Pain Refractory to Monopolar Pulsed Radiofrequency Treatment. Pain Physician. 2018 Mar;21(2):E97-E103.
    Results Reference
    result
    PubMed Identifier
    32281592
    Citation
    Marliana A, Yudianta S, Subagya DW, Setyopranoto I, Setyaningsih I, Tursina Srie C, Setyawan R, Rhatomy S. The efficacy of pulsed radiofrequency intervention of the lumbar dorsal root ganglion in patients with chronic lumbar radicular pain. Med J Malaysia. 2020 Mar;75(2):124-129.
    Results Reference
    result
    PubMed Identifier
    21812907
    Citation
    Van Boxem K, van Bilsen J, de Meij N, Herrler A, Kessels F, Van Zundert J, van Kleef M. Pulsed radiofrequency treatment adjacent to the lumbar dorsal root ganglion for the management of lumbosacral radicular syndrome: a clinical audit. Pain Med. 2011 Sep;12(9):1322-30. doi: 10.1111/j.1526-4637.2011.01202.x. Epub 2011 Aug 3.
    Results Reference
    result
    PubMed Identifier
    28700369
    Citation
    Vanneste T, Van Lantschoot A, Van Boxem K, Van Zundert J. Pulsed radiofrequency in chronic pain. Curr Opin Anaesthesiol. 2017 Oct;30(5):577-582. doi: 10.1097/ACO.0000000000000502.
    Results Reference
    result
    PubMed Identifier
    31577546
    Citation
    Vigneri S, Sindaco G, La Grua M, Zanella M, Lo Bianco G, Paci V, Vinci FM, Sciacca C, Ravaioli L, Pari G. Electrocatheter-mediated High-voltage Pulsed Radiofrequency of the Dorsal Root Ganglion in the Treatment of Chronic Lumbosacral Neuropathic Pain: A Randomized Controlled Study. Clin J Pain. 2020 Jan;36(1):25-33. doi: 10.1097/AJP.0000000000000766.
    Results Reference
    result
    PubMed Identifier
    31337167
    Citation
    Wan C, Dong DS, Song T. High-Voltage, Long-Duration Pulsed Radiofrequency on Gasserian Ganglion Improves Acute/Subacute Zoster-Related Trigeminal Neuralgia: A Randomized, Double-Blinded, Controlled Trial. Pain Physician. 2019 Jul;22(4):361-368.
    Results Reference
    result
    PubMed Identifier
    27389115
    Citation
    Wan CF, Liu Y, Dong DS, Zhao L, Xi Q, Yu X, Cui WY, Wang QS, Song T. Bipolar High-Voltage, Long-Duration Pulsed Radiofrequency Improves Pain Relief in Postherpetic Neuralgia. Pain Physician. 2016 Jul;19(5):E721-8.
    Results Reference
    result
    PubMed Identifier
    32791709
    Citation
    Yang S, Kim W, Kong HH, Do KH, Choi KH. Epidural steroid injection versus conservative treatment for patients with lumbosacral radicular pain: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2020 Jul 24;99(30):e21283. doi: 10.1097/MD.0000000000021283.
    Results Reference
    result

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    Pulsed Radiofrequency in Chronic Lumbosacral Radicular Pain

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