Prolotherapy Versus Epidural Steroid Injections (ESI) for Lumbar Pain Radiating to the Leg
Condition: Sciatica; Spinal Stenosis of Lumbar Region; Degeneration of Lumbar or Lumbosacral Intervertebral Disc
MeSH terms: Spinal Stenosis; Sciatica
Study type: Interventional
Phase: Phase 4

Summary: 
      The hypothesis is that in the treatment of low back pain (LBP) radiating to the leg, the
      long-term results of prolotherapy are more effective than those of the current conventional
      treatment: epidural steroid injections (ESI). This research will examine the efficacy of
      prolotherapy injections versus epidural steroid injections for the treatment of low back pain
      radiating to the leg. This is a randomized, unblinded study, in which patients seen in the
      principle investigator's pain clinic will be randomly divided to receive treatments from
      either the experimental, prolotherapy group, or the active control, ESI group.
    

Detailed description: 
      The primary goal of the study is to investigate the long-term efficacy of prolotherapy for
      patients with LBP referring to the leg. The secondary goal is to compare this efficacy with
      that of epidural steroids. The reason for exploring options other than ESI is that the latter
      have proved to be disappointing. Comprehensive reviews have been written on interlaminar and
      transforaminal epidurals which basically show poor long-term results of longer than 3 months.
      In addition, ESI carries risks of neurological damage, epidural hematoma and infection.
      However, ESI continues to be the most widely used treatment worldwide. Research also shows
      that with increasing age, there is an increased incidence of ligament laxity,
      spondylolisthesis and angulation which may in turn lead to nerve impingement and
      deterioration in function with time. Sprained and strained ligaments are themselves capable
      of referring pain down the leg even as far as the ankle. Research shows that much of the pain
      referred down the leg is not from impinged nerve roots but from other soft tissues, such as
      the above-mentioned ligaments; these must be addressed and treated not only to treat pain but
      in order to improve function.

      The term prolotherapy is otherwise known as proliferative regeneration therapy and is aimed
      at doing just the opposite of cortisone, namely, to strengthen the structures injected,
      usually ligaments. Prolotherapy solutions are also used to treat partially torn tendons, as
      in the case of partial rotator cuff tears. Research on prolotherapy has shown that this
      treatment mode produces varying results in the treatment of low back pain and carries fewer
      risks than epidurals. One can infer from this that it may provide a safer and better
      long-term treatment method than ESI. Yelland's review shows that prolotherapy works for the
      treatment of LBP if this treatment method is combined with other measures such as exercises
      or manipulations. In this study, patients with low back pain radiating to the leg will be
      randomized to receive either epidural steroid injections or prolotherapy injections using a
      solution made up of 20% dextrose. In light of the results of the research quoted, it was
      decided to give exercise instructions tailored to every patient's condition. Both patients
      from the experimental and the control groups will receive this instruction in order to avoid
      the presence of another confounding variable.

      A precondition to being included in the trial is having either a CT or MRI of the lumbar
      spine within the previous 18 months and not having any of the exclusion criteria cited below.
      Once included in the trial, patients will be randomized into the study and control groups.
      All epidural injections will be performed under fluoroscopy, and radiocontrast dye will be
      injected to verify that the injectate will be given in the correct place. Patients in this
      group will receive 3 interlaminar epidural steroid injections approximately 4 weeks apart.
      The solution injected will be made up of 80mg methylprednisolone acetate with bupivacaine.
      The level injected will depend on the clinical picture.

      All of the prolotherapy dextrose injections will be performed under ultrasound guidance.
      Prolotherapy patients will receive 5 sessions approximately 4 weeks apart. In each session, 6
      injections in different areas of the lumbosacral spine and sacroiliac ligaments will be
      injected with 20% dextrose solution using a 25 gauge spinal needle. The targeted structures
      include the following: the facet joint capsular ligaments, interspinous ligaments, and some
      of the sacroiliac ligaments, depending on the clinical assessment. The clinical picture will
      determine what levels will be injected in each session.

      As described below, patients will be assessed prior to the study and after the study
      regarding their pain and function.

      Because several patients fail to improve and continue to suffer from severe pain, it was
      considered unethical to keep patients in their original grouping and prevent crossover for a
      period of 12 months.

      Crossover will be permitted if all of the following conditions apply:

        1. At least 1 month has passed since the last treatment in the original allocation group

        2. NRS pain levels are at least 6 out of 10

        3. Pain and function have not improved with the originally allocated treatment

        4. The patient requests the crossover. Participants will receive the same treatments in the
           crossover groups as patients who were originally allocated to those groups Therefore,
           patients who cross over to the epidural side will receive up to 3 epidural injections
           approximately 1 month apart. Participants who cross over to the prolotherapy grouping
           will receive up to 5 treatment sessions also approximately 1 month apart.

      Follow-up of crossover participants will also be performed in the same manner and by the same
      independent investigator as for non-cross-over participants at 1, 3, 6 and 12 months after
      the last crossover treatment.
    

Intervention name(s): prolotherapy solution of 20% dextrose; Epidural Steroid Injection
Intervention type(s): Drug; Drug
Intervention description(s): After verifying the anatomy of the lumbosacral spine under ultrasound, a 9cm 22 gauge needle will be used to inject the prolotherapy solution to each of the points specified. In order to view the needle under ultrasound, a needle at least as thick as 22G is required. In order for the prolotherapy injections to be safe, bone must be contacted in order to avoid nerve damage. At each point a total of 1cc prolotherapy solution will be injected.; Prior to the epidural injection a local anaesthetic solution of 1% lidocaine will be injected into the relevant subcutaneous and ligamentous interlaminar space. The injectant solution will be comprised of 80mg methylprednisolone combined with 10mg (2cc) 0.5% bupivicaine. The resulting 4cc will be diluted with another 4cc of normal saline giving a total volume of 8cc. A loss of resistance technique will be used and radiocontrast dye will be injected to verify the placement of the needle prior to injecting the steroid solution.
Other intervention name(s): Dextrose 20% solution
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a study comparing prolotherapy treatments with an active control, which happens to be the gold standard treatment for radicular pain.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: low back pain; sciatica; spinal stenosis; epidural injections; prolotherapy; sacroiliac pain or dysfunction.; Ligament laxity