Clinical Trials

The following two scientific trials are focused on patients with discogenic low back pain. More specifically, these clinical trials are directed at the treatment of Internal Disc Disruption Syndrome (IDDS). The difference between IDDS and DDD (symptomatic degenerative disc disease) is discussed separately within Dr. Helper’s website. As the patient, the simplest way of trying to understand whether IDDS refers to your back condition is this: If you have moderate or severe back pain and your doctor told you have only mild or mild to moderate degenerative changes on your MRI, you MAY be suffering from IDDS.

Biologics: Fibrin Sealant

At the 17th Annual Scientific Meeting of the International Spine Intervention Society (ISIS) an abstract entitled "Intradiscal injection of fibrin sealant for the treatment of symptomatic lumbar internal disc disruption: results of a prospective multicenter IDE pilot study with 6-month follow-up" was presented by authors Way Yin, MD et al. The purpose of this study was to assess the safety and preliminary efficacy of BIOSTAT BIOLOGX® Fibrin Sealant in human adults with chronic symptomatic lumbar internal disc disruption (IDD). The sealant occludes the anular fissures and lays down a tissue repair matrix. Essentially, it functions as a physical barrier between inflammatory substances in the disc and nerves within the fissures, and serves as a scaffold for tissue repair.

The original study included 15 adults with chronic axial low back pain (CLBP). These patients had "failed" conservative therapy and were deemed appropriate for this study after provocation discography for lumbar discogenic pain. The authors concluded that the sealant appears to be safe in adults with discogenic CLBP. As well, initial data suggests intradiscal fibrin sealant injection may improve pain and function in selected patients with IDDS.

Provocative Discography at L3-4, L4-5, L5-S1

Way Yin, M.D. is the Medical Director and Founder of Interventional Medical Associates of Bellingham in Bellingham, Washington. Dr. Yin is a leading expert in minimally invasive diagnostic and therapeutic interventions for spine related pain problems. He is now leading a large multi-centre randomized controlled trail (RCT) to more accurately study the efficacy of this fibrin sealant compared with placebo.

Inclusion Criteria - The primary criteria for entering this study are:

1. Age 18 or older and skeletally mature.
2. Chronic low back pain for at least 6 months.
3. Leg pain, if present, is not due to nerve compression.
4. Leg pain, if present, does not extend below the knee and is no greater than 50% of overall pain experience.
5. Low back pain unresponsive to at least 3 months of non-operative care, (e.g anti-inflammatory and analgesic medications, chiropractic manipulations, acupuncture, massage, physical therapy or home-directed lumbar exercise program).
6. Diagnostic medial branch block or facet joint injection between 18 months and 2 weeks prior to the study procedure indicates no facet joint involvement.
7. Diagnosis of symptomatic lumbar (L1-L2 - L5-S1) internal disc disruption (IDD), which requires confirmation of discogenic pain at one or two contiguous levels through positive precise provocation discography performed between 18 months and 2 weeks prior to the study procedure.
8. Minimal disc height loss -Disc height at least 66% of adjacent control disc

Thermal: Biacuplasty

Various radiofrequency procedures have been designed for the treatment of discogenic low back pain. The goal is to accurately place a radiofrequency device in the posterior of the intervertebral disc where the painful nerve endings are located. Electrical energy is then used to 'turn off' the nerve endings, thus decreasing the sensation of pain from the disc. Two technologies are traditionally discussed: Intradiscal Thermal Annuloplasty (IDTA); better known as Intradiscal Electrothermal Therapy (IDET) and Posterior Radiofrequency Ablation (PRFA).

Unfortunately, when closely studied, the efficacy of these radiofrequency procedures has failed to meet expectations. Therefore, scientists have begun to search for an improved approach to radiofrequency lesioning of the posterior disc annulus. Biacuplasty (Transdiscal) is the most recently developed thermal technology in interventional spine pain management. Simply put, biacuplasty claims to be an easier, more reliable, minimally invasive approach for burning the nerve fibres in your painful disc.

Illustration of the biacuplasty procedure. Notice the band of radiofrequency heat across the posterior aspect of the intervertebral disc.

In the journal of Pain Medicine (2008), Dr. Leonardo Kapural et al. published “Intervertebral Disc Biacuplasty for the Treatment of Lumbar Discogenic Pain: Results of a Six-Month Follow-Up”. The authors reported improved pain scores and functional capacity in most patients. Since then other investigators have reported similar results. The next step in the scientific evaluation of the efficacy of this procedure is a well-designed, multi-centre, randomized controlled trial. Recruitment for such a trial has begun.

Dr. Michael Gofeld, of the University of Washington, is one of the most respected minds in the management of complex pain disorders. Dr. Gofeld is the principal investigator of a multi-centre, randomized, placebo-controlled trial. He is accepting appropriate back pain patients to the University of Washington Centre for Pain Relief (Seattle, Washington) for entry into this study.

Inclusion Criteria:

1. Age ≥ 21
2. History of chronic low back pain (>6 months) unresponsive to non-operative care (including physical therapy, anti-inflammatory medication, epidurals, diagnostic facet joint/medial branch blocks, and sacroiliac joint interventions as performed or deemed appropriate by the Investigator)
3. Stabilized on pain medication regimen for >2 months as defined by a <10% change in dosage
4. Leg pain, if present, is not due to nerve compression.
5. Leg pain, if present, does not extend below the knee and is no greater than 50% of overall pain experience.
6. Single level concordant pain reproduction present on lumbar discography in desiccated disc. Magnetic resonance Imaging (MRI) image also supports discography findings. Changes in other disc spaces in the lumbar region do not demonstrate neural compressive lesion.
7. Minimal disc height loss -Disc height at least 50% of adjacent control disc

Dr. Helper’s Role

Dr. Helper is very excited about the science behind both of the clinical trials discussed above. Unfortunately, participation in either study is not available in Canada. Therefore, Dr. Helper will not have the opportunity to directly recruit patients for treatment (fibrin sealant or biacuplasty) through the False Creek Surgical Centre. Instead, Dr. Helper will support the scientific process by screening appropriate patients for recruitment to these two centres in Washington State.

• Under Dr. Helper’s care, patients with discogenic low back pain will have the opportunity to:
• Have essential radiological imaging (x-ray, MRI), performed and evaluated for eligibility.
• Undergo diagnostic testing
  • X-ray guided diagnostic blockade of the lumbar facet joints (medial branch blocks or intra-articular joint injections)
  • X-ray guided diagnostic blockade of the sacroiliac joints (if necessary)
  • Awake provocative discography by ISIS standards.
• Undergo treatment of their current spine pain condition via the latest technology available in Canada (if not a study candidate).
• Pre-entry counseling on the theoretical risks and benefits of the proposed treatment.

If a patient has met the inclusion criteria and is felt to be a good candidate for entry into one the two above clinical trials they will have the opportunity for referral to the United States.