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
ID
Bron
Verkorte titel
Aandoening
Chronic neuropathic radicular pain
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To determine the technical differences and the influence of single versus multiple lumbar levels in performing PRF treatment of lumbar radicular pain.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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
Onderzoeksopzet
Baseline: questionnaires and procedural variables
3 months: questionnaires and procedural variables
6 months: questionnaires and procedural variables
Onderzoeksproduct en/of interventie
Lumbar PRF procedure at baseline
Publiek
Jennifer Breel
0610019257
j.s.breel@amsterdamumc.nl
Wetenschappelijk
Jennifer Breel
0610019257
j.s.breel@amsterdamumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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| Register | ID |
|---|---|
| NTR-new | NL9396 |
| Ander register | METC of Amsterdam UMC, location AMC : W21_019 # 21.021 |