Lumbosacral Radicular SyndromeNCT00991237
PRF Treatment for Patients With Chronic Lumbosacral Radicular Pain Compared to Conventional Medical Management
A study testing Pulsed Radiofrequency in people with Lumbosacral Radicular Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of the study is to evaluate the effect of PRF treatment adjacent to the lumbar dorsal root ganglion (DRG) of L5 or S1 in patients with a chronic lumbosacral radicular syndrome (LRS). Prospective, single blinded, multicenter clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lumbosacral Radicular Syndrome
- What is being tested?
- Pulsed Radiofrequency
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2010to Dec 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Symptoms more than 3 months 18,48
- Optimized conventional medical management at least for 1 month
- Pain radiating into the leg, up to the hallux (big toe) (L5) or little toe (S1)
- The pain in the leg dominates over a possible lumbalgia, the average pain in the leg measured 3 times a day, at predefined time points, over 4 consecutive days prior to inclusion should be more than 5 (NRS 10-point scale) 8
- Pattern of radiation suggestive for L5 or S1 pathology 49,50
- One or more positive neurological tests of nerve root tension or neurological deficit 51 ; straight leg raising test (SLRT), contralateral SLRT, motor reaction during SLRT and passive cervical flexion, motor reaction during passive cervical flexion while bending forward in standing position
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- Capable of understanding the information relative to the treatment and procedure and willing to provide informed consent
- Capable of understanding and filling-out the questionnaires necessary for evaluation of the treatments
- Patients having undergone low back surgery like discectomy with or without laminectomy are allowed to participate in the study
Who cannot join
- Patients younger than 18 years
- Malignant disorder or currently under treatment for a malignant disorder
- Previous lumbar fractures
- Proven myelum lesion or abnormalities in the central neurological structures
- Systemic or connective tissue diseases
- Diabetes mellitus type I
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- Multiple sclerosis
- Coagulation disorders
- Pregnancy
- Conventional medical management less then 1 month
- Pain Catastrophizing Scale > 45. When the patient has a higher score he/she will first be referred to a psychologist for consultation 52
- Leg pain due to localized hip or knee pathology
- Patients with a pacemaker or neurostimulator
- Patients previously treated with RF or PRF of the lumbar DRG
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, Limburg, 6217 jn
About this study
Official title: Pulsed Radiofrequency Treatment of the Lumbar Dorsal Root Ganglion for Patients With Chronic Lumbosacral Radicular Pain
The purpose of the study is to evaluate the effect of PRF treatment adjacent to the lumbar dorsal root ganglion (DRG) of L5 or S1 in patients with a chronic lumbosacral radicular syndrome (LRS).
Prospective, single blinded, multicenter clinical trial.
- Conditions
- Lumbosacral Radicular Syndrome
- Being tested
- Pulsed Radiofrequency
- Keywords
- NRS, GPE, pain reduction, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed RadiofrequencyOther
Also called PRF
Pulsed Radiofrequency
| Study group | Role | What they receive |
|---|---|---|
| Pain reduction | Experimental | Not described Receives: Other: Pulsed Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction
Measured: 2 months
Secondary outcomes (1)
Quality of life
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startFeb 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbosacral Radicular SyndromeStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg, Sint Jozef Hospital Bornem en Willebroek Belgium
- Responsible party
- Sponsor
- Investigators
- Maarten v Kleef, Prof. dr., Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991237
- Sponsor's protocol ID
- NL28367.068.09
- Status last verified
- Oct 2013
- First submitted
- 6 Oct 2009
- Last updated
- 24 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Radiofrequency Treatment of the Lumbar Dorsal Root Ganglion for Patients With Chronic Lumbosacral Radicular Pain
- ClinicalTrials.gov ID
- NCT00991237
- Acronym / sponsor ID
- NL28367.068.09
- Conditions
- Lumbosacral Radicular Syndrome
- Keywords
- NRS, GPE, pain reduction, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg, Sint Jozef Hospital Bornem en Willebroek Belgium
- Study start
- Feb 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 7 Oct 2009 (estimated)
- 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.
The purpose of the study is to evaluate the effect of PRF treatment adjacent to the lumbar dorsal root ganglion (DRG) of L5 or S1 in patients with a chronic lumbosacral radicular syndrome (LRS).
Prospective, single blinded, multicenter clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain reduction | Experimental | Other: Pulsed Radiofrequency |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Symptoms more than 3 months 18,48
- Optimized conventional medical management at least for 1 month
- Pain radiating into the leg, up to the hallux (big toe) (L5) or little toe (S1)
- The pain in the leg dominates over a possible lumbalgia, the average pain in the leg measured 3 times a day, at predefined time points, over 4 consecutive days prior to inclusion should be more than 5 (NRS 10-point scale) 8
- Pattern of radiation suggestive for L5 or S1 pathology 49,50
Key exclusion criteria (14 listed)
- Patients younger than 18 years
- Malignant disorder or currently under treatment for a malignant disorder
- Previous lumbar fractures
- Proven myelum lesion or abnormalities in the central neurological structures
- Systemic or connective tissue diseases
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 RadiofrequencyAlso: PRFPulsed Radiofrequency | Other | Pain reduction |
Primary outcome
Pain reduction
Time frame: 2 months
1 secondary outcome
Quality of life
Time frame: 2 months
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 24 Oct 2013.
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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.
Maarten v Kleef, Prof. dr. principal investigator
Maastricht UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Radiofrequency in people with Lumbosacral Radicular Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
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 9 inclusion and 14 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 24 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Pain reduction (time frame: 2 months). 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 24 Oct 2013.