SciaticaPRATSNCT04209322
Trial of Pulsed Radiofrequency for Sciatica and Disc Herniation
A study testing pulsed Radiofrequency and Transforaminal Epidural Steroid Injection in people with Sciatica and Lumbar Disc Herniation, run by University of Roma La Sapienza at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sciatica, Lumbar Disc Herniation
- What is being tested?
- pulsed Radiofrequency and Transforaminal Epidural Steroid Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Feb 2017to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 at least 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 were not considered contraindications
Who cannot join
- Patients presenting with previous spine surgery, spondylolisthesis, cauda equina syndrome, muscle paralysis, or insufficient strength to move against gravity were excluded.
- Vertebral canal stenosis
- Other exclusion criteria were cardiac pace-maker implant, pregnancy, or severe coexisting disease.
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read more
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.
Read the detailed description
The investigators conducted a multicenter, prospective, randomized trial among patients with at least 6 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 at least 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 an unstratified variable-block size of 2 and 4. The order of blocks was also randomized with patients assigned (1:1) to PRF/TFESI (treatment) or TFESI (control). 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.
- Conditions
- Sciatica, Lumbar Disc Herniation
- Being tested
- pulsed Radiofrequency, Transforaminal Epidural Steroid Injection
- Keywords
- sciatica, lumbar disc herniation, radiofrequency, non invasive treatment
- Medical subject headings
- Sciatica, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed RadiofrequencyProcedure or surgery
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
Transforaminal Epidural Steroid InjectionProcedure or surgery
Percutaneous injection of steroid in the nerve root foramen. The procedure was guided by CT imaging
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Radiofrequency | Experimental | 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 1mL lidocaine 20mg/mL mixed with 2mL dexamethasone 10mg/mL. Receives: Procedure: pulsed Radiofrequency |
| Transforaminal Epidural Steroid Injection | Active comparator | 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 1mL lidocaine 20mg/mL mixed with 2mL dexamethasone 10mg/mL. Receives: Procedure: Transforaminal Epidural Steroid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg-Pain Intensity
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 and 52 weeks.
Measured: 52 weeks
Secondary outcomes (3)
Roland Morris disability questionnaire
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.
Measured: 52 weeks
Oswestry Disability Index questionnaire
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.
Measured: 52 weeks
Pain change questionnaire
global perceived effect (post-treatment symptoms as compared with baseline, on a scale from -5 [vastly worse] to 0 [unchanged], to +5 [completely recovered])
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start1 Feb 2017
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SciaticaStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicenter, prospective, randomized trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Napoli, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209322
- Sponsor's protocol ID
- PRF003
- Acronym
- PRATS
- Status last verified
- Mar 2022
- First submitted
- 10 Dec 2019
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Pulsed Radiofrequency for Sciatica and Disc Herniation
- ClinicalTrials.gov ID
- NCT04209322
- Acronym / sponsor ID
- PRATS / PRF003
- Conditions
- Sciatica, Lumbar Disc Herniation
- Keywords
- sciatica, lumbar disc herniation, radiofrequency, non invasive treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators conducted a multicenter, prospective, randomized trial among patients with at least 6 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 at least 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 an unstratified variable-block size of 2 and 4. The order of blocks was also randomized with patients assigned (1:1) to PRF/TFESI (treatment) or TFESI (control). 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- multicenter, prospective, randomized trial
| Arm | Type | Receives |
|---|---|---|
| Pulsed Radiofrequency | Experimental | Procedure: pulsed RadiofrequencyAseptic 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 1mL lidocaine 20mg/mL mixed with 2mL dexamethasone 10mg/mL. |
| Transforaminal Epidural Steroid Injection | Active comparator | Procedure: Transforaminal Epidural Steroid InjectionAseptic 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 1mL lidocaine 20mg/mL mixed with 2mL dexamethasone 10mg/mL. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 at least 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 were not considered contraindications
Key exclusion criteria (3 listed)
- Patients presenting with previous spine surgery, spondylolisthesis, cauda equina syndrome, muscle paralysis, or insufficient strength to move against gravity were excluded.
- Vertebral canal stenosis
- Other exclusion criteria were cardiac pace-maker implant, pregnancy, or severe coexisting disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulsed RadiofrequencyNon-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 | Procedure or surgery | Pulsed Radiofrequency |
| Transforaminal Epidural Steroid InjectionPercutaneous injection of steroid in the nerve root foramen. The procedure was guided by CT imaging | Procedure or surgery | Transforaminal Epidural Steroid Injection |
Primary outcome
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 and 52 weeks.
3 secondary outcomes
Roland Morris disability questionnaire
Time frame: 52 weeks
Oswestry Disability Index questionnaire
Time frame: 52 weeks
Pain change questionnaire
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulsed Radiofrequency and Transforaminal Epidural Steroid Injection in people with Sciatica and Lumbar Disc Herniation, run by University of Roma La Sapienza at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leg-Pain Intensity (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.