Licciardone John C, Kearns Cathleen M, Hodge Lisa M, Minotti Dennis E
The Osteopathic Research Center, University of North Texas Health Science Center, Fort Worth, TX 76107-2644, USA.
J Am Osteopath Assoc. 2013 Jun;113(6):468-78.
Chronic pain is often present in patients with diabetes mellitus.
To assess the effects of osteopathic manual treatment (OMT) in patients with diabetes mellitus and comorbid chronic low back pain (LBP).
Randomized, double-blind, sham-controlled, 2×2 factorial trial, including OMT and ultrasound therapy (UST) interventions.
University-based study in Dallas-Fort Worth, Texas.
A subgroup of 34 patients (7%) with diabetes mellitus within 455 adult patients with nonspecific chronic LBP enrolled in the OSTEOPAThic Health outcomes In Chronic low back pain (OSTEOPATHIC) Trial.
The Outpatient Osteopathic SOAP Note Form was used to measure somatic dysfunction at baseline. A 100-mm visual analog scale was used to measure LBP severity over 12 weeks from randomization to study exit. Paired serum concentrations of tumor-necrosis factor (TNF)-α obtained at baseline and study exit were available for 6 subgroup patients.
Key osteopathic lesions were observed in 27 patients (79%) with diabetes mellitus vs 243 patients (58%) without diabetes mellitus (P=.01). The reduction in LBP severity over 12 weeks was significantly greater in 19 patients with diabetes mellitus who received OMT than in 15 patients with diabetes mellitus who received sham OMT (mean between-group difference in changes in the visual analog scale pain score, -17 mm; 95% confidence interval [CI], -32 mm to -1 mm; P=.04). This difference was clinically relevant (Cohen d=0.7). A corresponding significantly greater reduction in TNF-α serum concentration was noted in patients with diabetes mellitus who received OMT, compared with those who received sham OMT (mean between-group difference, -6.6 pg/mL; 95% CI, -12.4 to -0.8 pg/mL; P=.03). This reduction was also clinically relevant (Cohen d=2.7). No significant changes in LBP severity or TNF-α serum concentration were associated with UST during the 12-week period.
Severe somatic dysfunction was present significantly more often in patients with diabetes mellitus than in patients without diabetes mellitus. Patients with diabetes mellitus who received OMT had significant reductions in LBP severity during the 12-week period. Decreased circulating levels of TNF-α may represent a possible mechanism for OMT effects in patients with diabetes mellitus. A larger clinical trial of patients with diabetes mellitus and comorbid chronic LBP is warranted to more definitively assess the efficacy and mechanisms of action of OMT in this population.
糖尿病患者常伴有慢性疼痛。
评估整骨手法治疗（OMT）对糖尿病合并慢性下腰痛（LBP）患者的疗效。
随机、双盲、假对照、2×2析因试验，包括OMT和超声治疗（UST）干预。
德克萨斯州达拉斯 - 沃思堡的一项基于大学的研究。
在整骨疗法治疗慢性下腰痛（OSTEOPATHIC）试验中纳入的455例非特异性慢性LBP成年患者中的34例（7%）糖尿病患者亚组。
使用门诊整骨疗法SOAP记录表格在基线时测量躯体功能障碍。使用100毫米视觉模拟量表从随机分组到研究结束的12周内测量LBP严重程度。6例亚组患者可获得基线和研究结束时配对的肿瘤坏死因子（TNF）-α血清浓度。
27例（79%）糖尿病患者出现关键整骨病变，而无糖尿病患者为243例（58%）（P = 0.01）。接受OMT的19例糖尿病患者在12周内LBP严重程度的降低显著大于接受假OMT的15例糖尿病患者（视觉模拟量表疼痛评分变化的组间平均差异为 -17毫米；95%置信区间[CI]，-32毫米至 -1毫米；P = 0.04）。这种差异具有临床意义（Cohen d = 0.7）。与接受假OMT的患者相比，接受OMT的糖尿病患者TNF-α血清浓度相应显著降低（组间平均差异为 -6.6 pg/mL；95% CI，-12.4至 -0.8 pg/mL；P = 0.03）。这种降低也具有临床意义（Cohen d = 2.7）。在12周期间，UST与LBP严重程度或TNF-α血清浓度无显著变化相关。
糖尿病患者中严重躯体功能障碍的出现频率显著高于非糖尿病患者。接受OMT的糖尿病患者在12周内LBP严重程度显著降低。TNF-α循环水平降低可能是OMT对糖尿病患者产生作用的一种可能机制。有必要对糖尿病合并慢性LBP患者进行更大规模的临床试验，以更明确地评估OMT在该人群中的疗效和作用机制。
