back pain score image
Figure 2: Back pain score
(larger view)

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Figure 3: Quality of Life measure
(larger view)

total eq 5d score image
Figure 4: Quality of Life measure
(larger view)

roland morris score image
Figure 5: Disability measure
(larger view)

Outcomes according to the clinical trial:

Back Pain

The balloon kyphoplasty group had significantly less back pain than the non-surgical control group throughout the 12 months, with differences in back pain scores especially noticeable after the first month (see Figure 2). This metric was based on patient self-rated back pain (average pain in past week) on a 0 (no pain) to 10 (worst pain imaginable) visual-analogue scale.

  • The balloon kyphoplasty group had significantly favorable scores than the nonsurgical group, starting at 1 month with 2.2 points more improvement from their starting state (prior to any care) and ending at 0.9 points more improvement at 12 months.

Quality of Life

Balloon kyphoplasty, in comparison to non-surgical care, provided faster and greater improvements in quality of life at 1 month and sustained better quality of life scores over 12 months, as seen on two separate quality of life scales (see Figure 3 and Figure 4).

  • Short-Form (SF)-36 physical component summary (PCS) scale is a widely used quality of life measure. It measures physical (e.g., physical function, pain) and mental (e.g., mental health, social function) components via 36 questions posed to the patient. The scale is 0-100 with 0 being the least favorable and 100 being the most favorable, with an expected range of between 8 and 59 points for people over 65 years of age.
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  • The balloon kyphoplasty group had more favorable scores than the nonsurgical group, starting at 1 month with 5.2 points more improvement from their starting state (prior to any care) and ending at 1.5 points more improvement at 12 months.
  • Euro Qol-5D (EQ-5D) is a quality of life questionnaire with a 0 to 1 index scale, with 0 being the presence of severe problems and 1 being the absence of problems as reported by the patient. It measures 5 areas: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
  • The balloon kyphoplasty group had significantly more favorable scores than the nonsurgical group, starting at 1 month with 0.18 points more improvement from their starting state and ending at 0.12 points more improvement at 12 months.
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Disability

  • The Roland-Morris Back Function Scale is a questionnaire that measures disability due to back pain across 24 questions asked of the patient, e.g., I walk more slowly than usual because of my back. This back function scale is 0 to 24 points, with higher scores on this scale associated with greater disability.
  • Balloon kyphoplasty patients reported significantly less disability on the Roland-Morris Back Function Scale compared to non-surgical patients throughout the 12 months (see Figure 5). The balloon kyphoplasty group had significantly more favorable scores than the nonsurgical group, starting at 1 month with 4.0 points more improvement from their starting state and ending at 2.6 points more improvement at 12 months.
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