Lateral Branch Cooled Radiofrequency Denervation vs. Conservative Therapy for Sacroiliac Joint Pain
Condition: Sacroiliac Joint Pain
MeSH terms: Arthralgia
Study type: Interventional

Summary: 
      This is a prospective, randomized, controlled, multi-center clinical study. Approximately 208
      subjects will be enrolled at approximately 12-15 active duty military, veterans' care, and
      civilian sites. Eligible subjects will be randomized in 1:1 ratio to receive either
      Sacroiliac denervation using CRF (treatment group) or standard medical management ("SMM,"
      control group).
    

Detailed description: 
      This study will be a 12-month prospective, randomized, controlled, prospective, open-label,
      multi-center clinical study. Adult subjects over the age of 21 with diagnosed chronic
      intractable sacroiliac joint pain (≥ 3 months), who have been previously unresponsive to
      conservative therapy and who meet the selection criteria are eligible to participate in this
      study. Approximately 208 subjects will be enrolled at up to 15 sites in a 1:1 randomization
      ratio to receive either denervation using the SInergy System (cooled radiofrequency (CRF),
      treatment group) or standard medical management (SMM, control group). Follow-up will be
      conducted for a total of 12 months post-Coolief (cooled radiofrequency ablation) procedure,
      with the primary endpoint being completed at month 3. The control arm will utilize physician
      prescribed standard medical management (SMM). For this protocol, this includes, but is not
      limited to, medications, physical therapy, lifestyle changes, acupuncture, yoga,
      chiropractic, and therapeutic injections. An optional crossover-to-treatment design was
      adopted for subjects randomized to standard medical management after their 3-month visit,
      because it would be considered unethical to withhold treatment that could potentially offer
      pain relief to those subjects undergoing standard medical management who continue to suffer
      from pain.

      Eligibility includes BOTH of the following:

        -  50% pain relief lasting for the expected duration of anesthetic or medication from a
           therapeutic or diagnostic sacroiliac joint injection; AND

             -  50% pain relief lasting for the expected duration of anesthetic from a standardized
                set of lateral branch blocks, with total volume of no more than 1 milliliter (ml)
                of 0.5% Bupivacaine, Ropivacaine (or similar). Ideally, 0.5 ml will be utilized at
                L5 and the remaining 0.5 ml should be divided in at least two locations along the
                foramen line

      After the CRF treatment, the CRF treatment group subjects will visit the blinded assessor for
      follow up at 1, 3, 6, 9, and 12 months. At the month 3 visit (three months
      post-randomization), subjects initially randomized to the conservative therapy group will be
      assessed to determine eligibility to receive CRF treatment.

        -  If the conservative treatment subjects fail conservative therapy at 3 months (defined as
           failure to obtain a 2-point decrease in average pain score from baseline AND failure to
           obtain a rating of at least 5 on the Patient Global Impression of Change (PGIC) scale),
           they will be given the option of receiving CRF treatment.

        -  Subjects who choose to cross-over will ideally receive treatment within 30 days of their
           3-month visit but they must receive treatment within 90 days of their 3-month visit.
           They will then be followed-up at 1, 3, 6, 9, and 12 months following CRF denervation
           (new Day 0).

        -  If the conservative treatment group subjects refuse or don't qualify for CRF treatment
           at 3 months, they will subsequently be followed-up at 6, 9, and 12 months from their Day
           0.

      Primary Analysis is planned after all initially treated subjects have completed their 3-month
      post-procedure visit.
    

Intervention name(s): SInergy Cooled Radiofrequency; Medical Management
Intervention type(s): Device; Other
Intervention description(s): ablation of low back pain; physical therapy, medications, lifestyle changes
Other intervention name(s): SInergy; Standard Medical Management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Back Pain; Low Back Pain; Sacroiliac Back Pain