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| A randomized clinical trial comparing extensible and inextensible lumbosacral orthoses and standard care alone in the management of lower back pain [with consumer summary] |
| Morrisette D, Cholewicki J, Logan S, Seif G, McGowan S |
| Spine 2014 Oct 1;39(21):1733-1742 |
| clinical trial |
| 7/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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STUDY DESIGN: Single blinded, randomized clinical trial for the evaluation of lumbosacral orthoses (LSOs) in the management of lower back pain (LBP). OBJECTIVE: To evaluate the effects of two types of LSO on self-rated disability in patients with lower back pain. SUMMARY OF BACKGROUND DATA: LSOs are commonly used for the management of LBP, but their effectiveness may vary due to design. An inextensible LSO (iLSO) reduce trunk motion and increases trunk stiffness, whereas an extensible LSO (eLSO) does not. METHODS: 98 participants with LBP were randomized to three groups: (1) standard care group (SC), which included medication and physical therapy (n = 29), (2) SC with eLSO (eLSO group) (n = 32), and (3) SC with iLSO (iLSO group) (n = 37). Outcome measures were evaluated before and after 2 weeks of treatment: modified Oswestry Disability Index (ODI), Patient Specific Activity Score (PSAS), pain ratings, and Fear and Avoidance Beliefs Questionnaire (FABQ). RESULTS: There were no statistically significant differences between groups at baseline. Compared to the SC alone, iLSO group showed greater improvement on the ODI scores (p = 0.01), but not the eLSO group. The ODI scores improved by a mean of 2.4 (95% CI -2.2 to 7.1), 8.1 (95% CI 2.8 to 13.4), and 14.0 (95% CI 8.2 to 19.8) points for SC, eLSO, and iLSO groups respectively. Individuals wearing the iLSO had 4.7 times higher odds of achieving 50% or greater improvement in the ODI scores compared to those assigned to SC (95% CI 1.2 to 18.5, p = 0.03). Both the eLSO and iLSO groups had a greater improvement in the PSAS scores compared to SC (p = 0.05 and p = 0.01, respectively), but the change did not meet the minimal clinically important difference. Pain ratings improved for all three groups, with no statistical difference between them. Finally, no significant differences across groups were found for the FABQ. CONCLUSIONS: An iLSO led to greater improvement in ODI scores in comparison with SC and an eLSO. We surmise that the likely mechanism responsible for this difference in outcome was the added trunk stiffness and motion restriction by the iLSO. LEVEL OF EVIDENCE: 2.
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