Pulsed Radiofrequency in Chronic Lumbosacral Radicular Pain

NCT05713032 | Completed

• 1 other identifier: E/C. S/N. T124/2022
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Conditions

Lumbar Radiculopathy

Outcome Measures

Primary Outcomes (1)

• 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)

  6 months

Secondary Outcomes (1)

• Oswestry low back disability questionnaire

  6 months

Other Outcomes (1)

• Record of Complications intra or post-intervention

  6 months

Study Arms (2)

standard voltage group

ACTIVE COMPARATOR

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.

Procedure: Pulsed radiofrequency on lumbar dorsal root ganglion

high voltage group

ACTIVE COMPARATOR

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.

Procedure: Pulsed radiofrequency on lumbar dorsal root ganglion

Interventions

Pulsed radiofrequency on lumbar dorsal root ganglion PROCEDURE

voltage of pulsed radiofrequency on DRG

high voltage group; standard voltage group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Medical Research Institute

Alexandria, Al, 1234, Egypt

Location

Related Publications (11)

• 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.

  PMID: 34265792 RESULT

• 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.

  PMID: 24641192 RESULT

• 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.

  PMID: 29983585 RESULT

• 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.

  PMID: 29565952 RESULT

• 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.

  PMID: 32281592 RESULT

• 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.

  PMID: 21812907 RESULT

• 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.

  PMID: 28700369 RESULT

• 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.

  PMID: 31577546 RESULT

• 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.

  PMID: 31337167 RESULT

• 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.

  PMID: 27389115 RESULT

• 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.

  PMID: 32791709 RESULT

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Sahar A Elkaradawy, professor

  yes

  STUDY DIRECTOR

• Mohamed H Ellakany, professor

  yes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 6, 2023
• Study Start: February 1, 2023
• Primary Completion: January 15, 2024
• Study Completion: February 14, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

EG (1)