From the Physical Medicine & Rehabilitation Service, VA North Texas Health Care System, Dallas, Texas (TMA); Department of Physical Medicine & Rehabilitation, UT Southwestern Medical Center at Dallas, Dallas, Texas (TMA, KJC); Edward Via College of Osteopathic Medicine-Louisiana Campus, Monroe, Louisiana (MK); Physical Medicine & Rehabilitation Service, VA North Texas Health Care System, Fort Worth, Texas (LY); Infirmary Medical Clinics, Mobile, Alabama (MH); Riverside Community Hospital, Riverside, California (C-KL); and Star Orthopedics and Sports Medicine, Coppell, Texas (JP).
Am J Phys Med Rehabil. 2021 Aug 1;100(8):742-749. doi: 10.1097/PHM.0000000000001743.
We performed this study to evaluate the effect of back bracing to treat patients with chronic low back pain.
This was a prospective, unblinded, randomized controlled trial of 61 adults with uncomplicated chronic low back pain (>12 wks) and imaging findings of degenerative spondylosis, to assess the effectiveness of a semirigid back brace. All study participants received back school instruction. The treatment group also received a lumbar orthosis and was instructed to wear it as needed for symptom relief. At baseline, 6 wks, 12 wks, and 6 mos after intervention, we collected: Numerical Rating Scale to measure pain intensity, Pain Disability Questionnaire, Patient-Reported Outcome Measurement Information System, and EuroQol 5-Dimension (EQ-5D) to measure patient-reported function and quality of life.
An interim analysis at the halfway point in enrollment (61 of 120 planned participants) revealed the Pain Disability Questionnaire, Patient-Reported Outcome Measurement Information System, and EQ-5D scores in the treatment group to be worse than in the control group, but no significant group differences in Numerical Rating Scale scores. Outcome differences between groups analyzed over time revealed (effect [P]): Pain Disability Questionnaire = 0.84 (0.04); Patient-Reported Outcome Measurement Information System = 0.78 (0.005); EQ-5D = 0.06 (0.01); and Numerical Rating Scale = 0.02 (0.6). We halted the study because continuation was unlikely to produce significant changes to the results.
In patients with uncomplicated chronic low back pain, a back brace when combined with education and exercise instruction did not provide any pain relief compared with education and exercise instruction alone.
Complete the self-assessment activity and evaluation online at http://www.physiatry.org/JournalCME.
Upon completion of this article, the reader should be able to: (1) Describe the effect of lumbar back bracing on pain intensity in patients with chronic low back pain; (2) Discuss the effects of lumbar back bracing on pain-related disability, function, and quality of life in patients with chronic low back pain; and (3) Understand the role of lumbar back bracing in the treatment of patients with chronic low back pain.
Advanced.
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我们进行这项研究是为了评估背带在治疗慢性下背痛患者中的作用。
这是一项前瞻性、非盲、随机对照试验，共纳入 61 例无并发症的慢性下背痛（>12 周）且影像学表现为退行性脊柱关节炎的成年人，评估半刚性背带的有效性。所有研究参与者均接受背部学校指导。治疗组还接受腰椎支具，并被指示在需要缓解症状时佩戴。在基线、6 周、12 周和干预后 6 个月时，我们收集了以下数据：数字评分量表（用于测量疼痛强度）、疼痛残疾问卷、患者报告的结果测量信息系统和欧洲五维健康量表（EQ-5D），以测量患者报告的功能和生活质量。
在招募过程中的中途进行的一项中期分析（计划参与者的 120 人中的 61 人）显示，治疗组的疼痛残疾问卷、患者报告的结果测量信息系统和 EQ-5D 评分均比对照组差，但数字评分量表评分无显著组间差异。随着时间的推移对组间结果进行分析显示（效应[P]）：疼痛残疾问卷=0.84（0.04）；患者报告的结果测量信息系统=0.78（0.005）；EQ-5D=0.06（0.01）；数字评分量表=0.02（0.6）。我们停止了这项研究，因为继续进行不太可能对结果产生显著影响。
在患有单纯性慢性下背痛的患者中，与教育和运动指导相比，背带结合教育和运动指导并不能提供任何缓解疼痛的效果。
