PMID- 25054648 OWN - NLM STAT- MEDLINE DCOM- 20151008 LR - 20240323 IS - 1528-1159 (Electronic) IS - 0362-2436 (Print) IS - 0362-2436 (Linking) VI - 39 IP - 21 DP - 2014 Oct 1 TI - A randomized clinical trial comparing extensible and inextensible lumbosacral orthoses and standard care alone in the management of lower back pain. PG - 1733-42 LID - 10.1097/BRS.0000000000000521 [doi] AB - 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 LSOs on self-rated disability in patients with LBP. SUMMARY OF BACKGROUND DATA: LSOs are commonly used for the management of LBP, but their effectiveness may vary because of design. An inextensible LSO (iLSO) reduces trunk motion and increases trunk stiffness, whereas an extensible LSO (eLSO) does not. METHODS: A total of 98 participants with LBP were randomized to 3 groups: (1) standard care (SC) group, 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 Scale, pain ratings, and Fear Avoidance Beliefs Questionnaire. RESULTS: There were no statistically significant differences between groups at baseline. Compared with 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% confidence interval [CI], 2.2-7.1), 8.1 (95% CI, 2.8-13.4), and 14.0 (95% CI, 8.2-19.8) 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 than those assigned to SC (95% CI, 1.2-18.5, P = 0.03). Both the eLSO and iLSO groups had a greater improvement in the Patient Specific Activity Scale scores than the SC group (P = .05 and P = 0.01, respectively), but the change did not meet the minimal clinically important difference. Pain ratings improved for all 3 groups, with no statistical difference between them. Finally, no significant differences across groups were found for the Fear Avoidance Beliefs Questionnaire. CONCLUSION: An iLSO led to greater improvement in ODI scores than 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. FAU - Morrisette, David C AU - Morrisette DC AD - *Division of Physical Therapy, College of Health Professions, Medical University of South Carolina, Charleston daggerCenter for Orthopedic Research, Osteopathic Surgical Specialties, College of Osteopathic Medicine, Michigan State University, East Lancing double daggerFamily Services Research Center, Medical University of South Carolina, Charleston section signDivision of Physical Therapy, College of Health Professions, Medical University of South Carolina, Charleston; and paragraph signDepartment of Physical Therapy, Medical University of South Carolina Hospital Authority, Charleston. FAU - Cholewicki, Jacek AU - Cholewicki J FAU - Logan, Sarah AU - Logan S FAU - Seif, Gretchen AU - Seif G FAU - McGowan, Stephanie AU - McGowan S LA - eng GR - UL1 TR000062/TR/NCATS NIH HHS/United States PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't PL - United States TA - Spine (Phila Pa 1976) JT - Spine JID - 7610646 SB - IM MH - Adult MH - Biomechanical Phenomena MH - Disability Evaluation MH - Equipment Design MH - Female MH - Humans MH - Low Back Pain/diagnosis/physiopathology/*therapy MH - Lumbar Vertebrae/*physiopathology MH - Male MH - Middle Aged MH - Numbers Needed To Treat MH - Orthopedic Procedures/*instrumentation MH - *Orthotic Devices MH - Pain Measurement MH - Sacrum/*physiopathology MH - Single-Blind Method MH - Surveys and Questionnaires MH - Time Factors MH - Treatment Outcome PMC - PMC4521401 MID - NIHMS702747 EDAT- 2014/07/24 06:00 MHDA- 2015/10/09 06:00 PMCR- 2015/10/01 CRDT- 2014/07/24 06:00 PHST- 2014/07/24 06:00 [entrez] PHST- 2014/07/24 06:00 [pubmed] PHST- 2015/10/09 06:00 [medline] PHST- 2015/10/01 00:00 [pmc-release] AID - 10.1097/BRS.0000000000000521 [doi] PST - ppublish SO - Spine (Phila Pa 1976). 2014 Oct 1;39(21):1733-42. doi: 10.1097/BRS.0000000000000521.