No registrations found.
ID
Source
Brief title
Health condition
Chronic neuropathic radicular pain
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the technical differences and the influence of single versus multiple lumbar levels in performing PRF treatment of lumbar radicular pain.
Secondary outcome
To relate the abovementioned variables to patient clinical outcomes such as effective pain reduction.
Background summary
Moderate evidence for treating lumbar radicular pain using PRF treatment is available. However PRF procedural settings such as voltage, number of cycles, treatment duration, and needle tip placement vary among pain physicians. Consequentially resistance (Ohm) and current (mA) can vary as well. Therefore is it not clear which treatment strategy contributes most substantial to pain reducing results.
The aim of the present prospective longitudinal observational data collection is twofold. First, the data collection should identify the degree of variability in performing PRF procedures in patients with LRP, between different hospitals in the Netherlands. Secondly, this data collection should identify differences in efficacy in pain reduction after 3 and 6 months, related to the different PRF treatment settings and needle tip positions.
These findings may help to obtain consensus on optimal PRF treatment duration, efficacy of single level versus multi level PRF, needle tip position, and length of active needle tip in order to obtain optimal pain reduction in patients with LRP. These data will serve as basis for new hypotheses regarding optimal PRF techniques to be tested in future RCT’s.
Study objective
To identify the degree of variability in performing PRF procedures in patients with LRP, between different hospitals in the Netherlands and relate it to the efficacy of the procedure
Study design
Baseline: questionnaires and procedural variables
3 months: questionnaires and procedural variables
6 months: questionnaires and procedural variables
Intervention
Lumbar PRF procedure at baseline
Jennifer Breel
0610019257
j.s.breel@amsterdamumc.nl
Jennifer Breel
0610019257
j.s.breel@amsterdamumc.nl
Inclusion criteria
• Patients >= 18 and <70 years
• Dutch speaking
• Dominant unilateral leg pain, with a back/leg pain ratio of at least 40/60%
• The leg pain should be the primary complaint with an average pain score of at least 5 on an 11-point numerical rating scale (NRS)
• Chronic LRP lasting >=6 months
• Previous inadequate conservative management such as physiotherapy, exercise therapy or analgesic (anti-neuropathic) medications
• Willing and able to sign consent for re-use of care data
Exclusion criteria
• Refusal to participate in the data collection
• Age < 18 or >70 years
• Acute pain of onset lasting <12 weeks
• Radicular pain in both legs
• Signs of progressive motor weakness or neurologic deficits
• Planned lumbar and/or sacral surgery
• Patients who received epidural steroid injection(s) within the previous 6 months
• Patients who received previous PRF treatment within the previous 6 months
• Systemic infection
• Injection site infection
• Hypersensitivity to LA and/or the radiographic contrast agent
• Malignancy/presence of cancer as a cause of radicular pain
• Presence of a cardiac pacemaker
• Unstable medical or psychiatric condition
• Other current pain syndromes besides lumbar radicular pain
• Inability to receive a 6 months follow up
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9396 |
| Other | METC of Amsterdam UMC, location AMC : W21_019 # 21.021 |