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Trial of Pulsed Radiofrequency for Sciatica and Disc Herniation (PRATS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04209322
Recruitment Status : Completed
First Posted : December 24, 2019
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Alessandro Napoli, University of Roma La Sapienza

Brief Summary:

Transforaminal epidural injection of treatments, commonly steroids (TFESI), is offered to people with sciatica and might improve symptoms, reduce disability and speed up return to normal activities (NICE guidelines) Imaging-guided TFESI has traditionally been performed in the sciatica context because injection is administered directly to the nerve root, which relieves the pain markedly; however, the maintenance time is usually short.

Treatment with radiofrequency for pain management is in clinical use since decades primarily with nerve lesioning (thermoablation) once the specific pain tributary nerve is identified.

Pulsed radiofrequency (PRF) with neuromodulation intention (not lesioning) has been shown to be effective in reducing some types of chronic pain, both degenerative and neuropathic.

Pulsed radiofrequency has been also extensively used in the context of acute and subacute sciatica due to disc herniation without sufficient level of evidence. In a prospective RCT, comparing prf directed to dorsal root ganglia and Tfesi in patients with sciatica did not allow conclusions on efficacy because of limitations of the trial. In that trial, only few participants completed the study due to violation of trial protocol translating the results as not consistent.

One retrospective trial, in which the use of Prf in addition to tfesi was evaluated in patients with acute and subacute sciatica, demonstrated rapid pain relief onset and prolonged maintenance; the overall efficacy was superior to that of the single method treatment (either tfsei or prf).

The investigators conducted a randomized, double-blind, controlled trial (Pulsed Radiofrequency in Addition to Tfesi for Sciatica [PRATS]) to determine if PRF in addition to TFESI leads to better outcomes in the management of patients with acute and subacute sciatica due to disc herniation, compared to TFESI alone.


Condition or disease Intervention/treatment Phase
Sciatica Lumbar Disc Herniation Procedure: pulsed Radiofrequency Procedure: Transforaminal Epidural Steroid Injection Not Applicable

Detailed Description:

The investigators conducted a multicenter, prospective, randomized trial among patients with 6 to 12 weeks of sciatic pain to determine whether a strategy of PRF in addition to TFESI leads to better outcomes during the first year than does a strategy of TFESI only means for sciatica treatment.

Eligible patients were 18 to 75 years of age, had a radiologically confirmed disk herniation, and had received a diagnosis from an attending neurologist of an incapacitating lumbosacral radicular syndrome that had lasted for 6 to 12 weeks. Correlation of magnetic resonance imaging (MRI) findings with symptoms was registered. Patients presenting with cauda equina syndrome, muscle paralysis, or insufficient strength to move against gravity were excluded. Other exclusion criteria were cardiac pace-maker implant, pregnancy, or severe coexisting disease. The occurrence of another episode of symptoms similar to those of the current episode during the previous 12 months, previous spine surgery and spondylolisthesis were not considered contraindications but bony stenosis.

A computer-generated permuted-block scheme was used for randomization, with patients stratified according to center. A few hours before randomization, the patients were evaluated again, and those who had recovered from their symptoms at that time were excluded from the trial.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: multicenter, prospective, randomized trial
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Trial of Pulsed Radiofrequency for Sciatica and Disc Herniation
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : January 31, 2020
Actual Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia Sciatica

Arm Intervention/treatment
Experimental: Pulsed Radiofrequency
Aseptic technique was adopted. Imaging guided (CT) catheter needle (active tip electrode) was inserted and a sensory stimulation test was carried out using an RF generator. The catheter needle was then advanced toward the DRG until the patient reported a tingling sensation and/or dysesthesia at less than 0.3V. PRF treatment was administered at 5 Hz and a 2 ms pulsed width for 10 minutes at 45V under the constraint that the electrode tip temperature not exceed 42°C. Finally, patients received 1 mL lidocaine 20 mg/ml mixed with 40 mg triamcinolone acetonide.
Procedure: pulsed Radiofrequency
Non-surgical treatment of lumbar disc herniation causing sciatica using pulsed radiofrequency (10 minutes) directed to the interested dorsal root ganglia (percutaneous technique); after radiofrequency application, using the same needle, steroid was administered (as per the control arm). The procedure was guided by CT imaging

Active Comparator: Transforaminal Epidural Steroid Injection
Aseptic technique was adopted. Imaging guided (CT) catheter needle (active tip electrode) was inserted and a sensory stimulation test was carried out using an RF generator. The catheter needle was then advanced toward the DRG until the patient reported a tingling sensation and/or dysesthesia at less than 0.3V. After 10 minutes await (as per pRF), patients received 1 mL lidocaine 20 mg/ml mixed with 40 mg triamcinolone acetonide.
Procedure: Transforaminal Epidural Steroid Injection
Percutaneous injection of steroid in the nerve root foramen. The procedure was guided by CT imaging




Primary Outcome Measures :
  1. Leg-Pain Intensity [ Time Frame: 52 weeks ]
    The primary outcome was the average leg-pain intensity score over the course of the previous 1 week (on a numerical pain-rating scale from 0 to 10, with 0 indicating no pain and 10 the worst possible pain; clinically important difference, 2 points), as assessed at 1 week, 4 weeks, 12 weeks and 52 weeks.


Secondary Outcome Measures :
  1. Roland Morris disability questionnaire [ Time Frame: 52 weeks ]
    extent of disability as measured on the Roland Disability Questionnaire for Sciatica (scores range from 0 to 23, with higher scores indicating greater disability; clinically important difference, 8 points), as assessed at 4 weeks, 12 weeks and 52 weeks.

  2. Oswestry Disability Index questionnaire [ Time Frame: 52 weeks ]
    extent of disability as measured on the Oswestry Disability Index (on a % scale from 0 to 100, version 2.0, MODEMS; clinically important difference, 10 points), as assessed at 4 weeks, 12 weeks and 52 weeks.

  3. Pain change questionnaire [ Time Frame: 52 weeks ]
    global perceived effect (post-treatment symptoms as compared with baseline, on a scale from −5 [vastly worse] to 0 [unchanged], to +5 [completely recovered])


Other Outcome Measures:
  1. Adverse events [ Time Frame: 52 weeks ]
    Data regarding treatment-related side-effects will be registered.

  2. workplace absenteeism questionnaire [ Time Frame: 52 weeks ]
    The cumulative number of days of workplace absenteeism due to sciatica

  3. Satisfaction on current condition [ Time Frame: 52 weeks ]
    Subjective evaluation of current condition, expressed in terms of percentage, with 0% indicating completely disappointed and 100% indicating completely satisfied



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible patients had radiologically confirmed disk herniation, and had received a diagnosis from an attending neurologist of an incapacitating lumbosacral radicular syndrome that had lasted for 6 to 12 weeks. Correlation of magnetic resonance imaging (MRI) findings with symptoms was required.
  • The occurrence of another episode of symptoms similar to those of the current episode during the previous 12 months, previous spine surgery and spondylolisthesis were not considered contraindications

Exclusion Criteria:

  • Patients presenting with cauda equina syndrome, muscle paralysis, or insufficient strength to move against gravity were excluded. Other exclusion criteria were cardiac pace-maker implant, pregnancy, or severe coexisting disease.
  • Vertebral canal stenosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209322


Locations
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Italy
Centro Sana
Aprilia, LT, Italy, 04011
Alessandro Napoli
Rome, Italy, 00100
Sponsors and Collaborators
University of Roma La Sapienza
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Responsible Party: Alessandro Napoli, Associated Professor of Radiology, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT04209322    
Other Study ID Numbers: PRF003
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data are available to all authors for 5 years after main study completion

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alessandro Napoli, University of Roma La Sapienza:
sciatica
lumbar disc herniation
radiofrequency
non invasive treatment
Additional relevant MeSH terms:
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Sciatica
Hernia
Pathological Conditions, Anatomical
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neuralgia
Pain
Neurologic Manifestations
Signs and Symptoms