Trial of Pulsed Radiofrequency for Sciatica and Disc Herniation
Condition: Sciatica; Lumbar Disc Herniation
MeSH terms: Intervertebral Disc Displacement; Sciatica; Hernia
Study type: Interventional

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.
    

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.
    

Intervention name(s): pulsed Radiofrequency; Transforaminal Epidural Steroid Injection
Intervention type(s): Procedure; Procedure
Intervention description(s): 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; Percutaneous injection of steroid in the nerve root foramen. The procedure was guided by CT imaging
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: multicenter, prospective, randomized trial
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: sciatica; lumbar disc herniation; radiofrequency; non invasive treatment