VA Long Beach Healthcare System, Long Beach, CA, USA.
Arch Phys Med Rehabil. 2012 Apr;93(4):617-22. doi: 10.1016/j.apmr.2011.11.021.
To assess the efficacy of a noninvasive limb cover for treating chronic phantom limb pain (PLP).
Randomized, double-blind, placebo-controlled trial.
Outpatient clinic.
We randomly assigned 57 subjects to 2 groups: true noninvasive limb cover (n=30) and sham noninvasive limb cover (n=27). Inclusion criteria included age of 18 years or greater, upper or lower extremity amputation with healed residual limb, and 3 or more episodes of PLP during the previous 6 weeks.
Subjects received 2 true or sham noninvasive limb covers to be worn over the prosthesis and residual limbs 24 hours a day for 12 weeks.
Primary outcome measure was the numerical pain rating scale of PLP level (0-10). Secondary outcomes included overall pain level (0-10), PLP frequency per week, and the Veterans RAND 12-Item Health Survey (VR-12). We collected data at baseline and at 6- and 12-week follow-up visits.
Demographic and clinical characteristics were not significantly different between groups. The true noninvasive limb cover group reported nonsignificant reductions in PLP from 5.9±1.9 at baseline to 3.9±1.7 at the 12-week follow-up. The sham noninvasive limb cover group also had nonsignificant reducations in PLP from 6.5±1.8 to 4.2±2.3. PLP did not differ significantly between the 2 groups at 6 weeks (mean difference, 0.8; 95% confidence interval [CI], -1.4 to 3) or at 12 weeks (mean difference, 0.2; 95% CI, -1.9 to 2.3). Similarly, overall pain level, PLP episodes per week, and VR-12 physical and mental health component scores did not differ between the 2 groups at 6 and 12 weeks.
A true noninvasive limb cover did not significantly decrease PLP levels or the frequency of PLP episodes per week, overall bodily pain levels, or VR-12 physical and mental health component scores compared with a sham noninvasive limb cover in our veteran amputee sample.
评估一种无创肢体套对治疗慢性幻肢痛（PLP）的疗效。
随机、双盲、安慰剂对照试验。
门诊。
我们将 57 名受试者随机分为 2 组：真实无创肢体套（n=30）和假无创肢体套（n=27）。纳入标准包括年龄 18 岁或以上、上肢或下肢截肢且残肢愈合、过去 6 周内出现 3 次或以上 PLP。
受试者接受 2 个真实或假无创肢体套，每天 24 小时佩戴在假肢和残肢上，持续 12 周。
主要结局指标为 PLP 水平的数字疼痛评分量表（0-10）。次要结局指标包括总体疼痛水平（0-10）、每周 PLP 发作频率以及退伍军人 RAND 12 项健康调查（VR-12）。我们在基线和 6 周及 12 周随访时收集数据。
两组的人口统计学和临床特征无显著差异。真实无创肢体套组报告 PLP 从基线时的 5.9±1.9 显著下降至 12 周随访时的 3.9±1.7。假无创肢体套组的 PLP 也从 6.5±1.8 显著下降至 4.2±2.3。两组在 6 周（平均差异，0.8；95%置信区间 [CI]，-1.4 至 3）或 12 周（平均差异，0.2；95% CI，-1.9 至 2.3）时的 PLP 差异无统计学意义。同样，两组在 6 周和 12 周时的总体疼痛水平、每周 PLP 发作次数以及 VR-12 生理和心理健康分量表评分也无差异。
在我们的退伍军人截肢者样本中，与假无创肢体套相比，真实无创肢体套并不能显著降低 PLP 水平或每周 PLP 发作次数、总体躯体疼痛水平或 VR-12 生理和心理健康分量表评分。
