Benefit of Lumbar Bracing for Chronic Low Back Pain Due to Degenerative Disc Disease
Condition: Degenerative Disc Disease; Lumbar Spondylosis; Low Back Pain
MeSH terms: Spinal Diseases; Intervertebral Disc Degeneration; Spondylosis; Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The main objectives of this study are to evaluate the benefits of back bracing in the
      symptomatic management of patients with CLBP due to degenerative lumbar disc disease. The
      plan is to study patients with uncomplicated CLBP without symptoms of radiculopathy or
      neurogenic claudication.

      The secondary objectives of the study are to evaluate if a back brace provides any additive
      benefit to usual care consisting of exercise and patient education in patients with CLBP due
      to degenerative disc disease.

      Specific Aim 1. To evaluate the effectiveness of back brace to improve pain and
      patient-reported functional measures in patients with uncomplicated CLBP due to degenerative
      disc and degenerative joint disease without associated symptoms of neurogenic claudication or
      lumbosacral radiculopathy.

      Hypothesis 1. Back brace in addition to usual care will provide statistically significant
      improvement in pain and functional measures compared to usual care alone.

      Specific Aim 2. To evaluate the adherence to back brace wear instructions in patients with
      uncomplicated CLBP due to degenerative disc and degenerative joint disease without associated
      symptoms of neurogenic claudication or lumbosacral radiculopathy Hypothesis 2. Patients with
      CLBP, due to degenerative disc and degenerative joint disease without associated symptoms of
      neurogenic claudication or lumbosacral radiculopathy, who are prescribed a back brace, will
      demonstrate clinically acceptable rates of adherence to brace wear instructions.
    

Detailed description: 
      Physiatrists use back braces (lumbar support, back corset, semi-rigid brace, and lumbar
      orthotic) for symptomatic management of patients' chronic low back pain (CLBP) despite very
      poor evidence supporting their use in the few published studies that have examined them.
      Evidence supporting back braces in other populations, such as pregnant women, and patients
      with sub-acute or acute low back pain, is better established. However, the benefits of back
      braces in the CLBP population are very unclear.

      A Cochrane review on the role of lumbar supports in treating chronic LBP revealed that
      limited evidence was available, which led to the conclusion that, "it remains unclear whether
      lumbar supports are more effective than no or other interventions for treating low-back
      pain." The research emphasized the need for high quality randomized trials evaluating the
      effectiveness of back braces, and also recommended that compliance of brace wear be
      monitored.

      The mechanism by which back braces might help patients with CLBP is also unclear. The
      semi-rigid design of the commonly used back brace does not mechanically limit movement enough
      to suggest that movement limitation is the mechanism by which back braces provide relief.
      However, some studies have suggested that back braces help patients with CLBP by providing
      postural support or a kinesthetic reminder of their posture. Using posturography, Munoz et
      al., studied the forces applied by lumbar bracing and concluded that back braces seem to help
      by improving the quality of balance strategy used by the patient. Another mechanism by which
      back braces are believed to help patients is by providing warmth underneath the brace.

      There is poor published information regarding adherence to instructions (compliance) about
      the use of back braces. Based on the investigators' anecdotal clinical experience, adherence
      rates vary widely among patients who are prescribed back braces, ranging from non-use to
      constant use around the clock. Poor adherence to instructions can be a significant factor
      resulting in inconclusive evidence supporting the role of back brace in patients with CLBP. A
      recent study showed that a strong predictor for consistent adherence to back brace usage was
      a positive attitude towards it. In this study, positive attitude towards the back brace
      explained 41% of the variance in outcomes. In addition, investigators found that perceived
      benefit from the brace outweighed any subjective discomfort.

      Back braces have been used as adjunctive therapy in addition to other conservative care
      options. A recent study evaluated the cumulative effect of bracing to exercise and found that
      bracing helps to increase trunk stiffness and augments muscle contractions, which may remind
      the patients to better comply with exercise instructions. This suggested a potential
      synergistic effect of bracing and exercise in the management of patients with CLBP.
    

Intervention name(s): Lumbar back brace; Back school
Intervention type(s): Other; Behavioral
Intervention description(s): A brace that supports the lumbar region of the spine.; Back school consists of patient education physical therapy exercise instruction.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a prospective, randomized controlled trial. Blinding of the subjects is not possible because a back brace is a visibly obvious intervention. In addition, since we are evaluating the adherence of back brace wear, blinding of the investigator is also not possible. Therefore, this study will be an unblinded RCT.
Masking: None (Open Label)
Primary purpose: Treatment