Discopathy with Leg Pain: A Randomized Controlled Trial of Orthotrac
Hypothesis: This study is designed to evaluate the results of using the Orthotrac Pneumatic Vest versus an EZ Form brace in patients with radiating leg pain from disc bulge/protrusion/herniation. Specifically, our hypothesis is that patients given the Orthotrac Pneumatic Vest (OPV) will have greater pain relief and increased self-reported functionality and fewer progressions to surgery that those using the EZ Form brace.
Methods: A randomized clinical trial was initiated to contrast the effects of OPV (n=75) versus EZ Form (EZ) (n=75) brace on patients with 4 weeks failed conservative care, MRI confirmed disc bulge or protrusion and radiating leg pain. Inclusion required ability to stand upright and consistent relief with recumbency. Follow-up evaluations were set at 6, 12, 26 and 52 week intervals. Measures included VAS, Oswestry, SF-36 and ROM.
Results: Initial results of patients who have reached the 12 week interval are available. Figure 1 shows the improvement in pain (LBP & leg pain now; LBP & leg pain in past week) observed with each device. OPV resulted in a 6 times greater reduction in back pain, 8 times for leg pain (p<0 .0003). Activities of daily living (Oswestry) improved 28 points versus 7.3 (p<0.019). The SF-36 mental health score increased by 24 for OPV but decreased 13 EZ (p<0.06). Flexion 20 degrees in the mean and 5.2 EZ.
Comparison of the pre- to post-treatment change in VAS scores in the two treatment groups.
Column 1: LBP New
Column 2: LBP Wk
Column 3: Leg Pain Now
Column 4: Leg Pain Wk
Legend: Blue = OPV, Gray = EZ
Discussion: Axial spine loading from body mass reduces the effective canal size in less than 5 minutes. Disc patients have radiating pain secondary to root compression or chemically induced inflammation of the nerve roots. In cadaver studies, the Orthotrac Vest (OPV) reduces functional disc load by approximately 25% by using pneumatic lifters between a stabilizing ring on the pelvis and a second one around the rib cage. Results from this study demonstrate significant benefit in relieving both back and leg pain, improving functionality and decreasing emotional stress.
Conclusions: A therapeutic method that can reduce axial loading while weight bearing has the potential of providing significant symptomatic relief while retaining functionality. Early results strongly favor use of the OPV for patients who have failed 4 weeks of conservative therapy and are carefully selected for showing relief from spine unloading.
Peer-reviewed and accepted for podium presentation at North American Spine Society 2003