A prospective, double-blind, pilot, randomized, controlled trial of an "embodied" virtual reality intervention for adults with low back pain.

A prospective, double-blind, pilot, randomized, controlled trial of an "embodied" virtual reality intervention for adults with low back pain.
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DOI:
10.1097/j.pain.0000000000002617
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发表时间:
2022-09-01
期刊:
影响因子:
7.4
通讯作者:
--
中科院分区:
医学1区
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文本中提供了补充数字内容。与假安慰剂和标准护理对照相比,一种针对腰痛患者的新型自动化虚拟现实心理干预减少了对运动的恐惧。患有慢性腰痛、残疾、中度至重度疼痛以及对运动和再次受伤高度恐惧的成年人被招募参加一项新颖的自动化数字疗法、虚拟现实、疼痛心理干预(DTxP)试验。我们进行了一项三臂、前瞻性、双盲、试点、随机、对照试验,将 DTxP 与假安慰剂比较剂和开放标签标准护理进行比较。参与者入组 6 至 8 周,之后,标准护理对照组被重新随机分配接受 DTxP 或假安慰剂。 42 名参与者完成了基线、治疗后(6-8 周)、9 周和 5 个月随访的评估。我们发现,与假安慰剂和治疗后标准护理相比,DTxP 组的参与者对运动的恐惧明显减少,对变化的整体印象更好。治疗后或随访时没有发现其他组间差异。与基线相比,DTxP 组的参与者在 5 个月的随访中报告残疾率较低,治疗后和随访后的疼痛干扰和对运动的恐惧较低,治疗后的疼痛强度较低。与基线相比,假安慰剂组在 5 个月的随访中还报告称,残疾和对运动的恐惧程度较低。标准护理没有报告任何重大变化。存在许多不良事件,一名参与者报告假安慰剂出现严重不良事件,该事件与治疗无关。药物治疗没有发生实质性变化,DTxP 组的参与者报告了积极的游戏体验。
Supplemental Digital Content is Available in the Text. A novel, automated, virtual reality, psychological intervention for people with low back pain reduced fear of movement compared with sham placebo and standard care control. Adults with chronic low back pain, disability, moderate-to-severe pain, and high fear of movement and reinjury were recruited into a trial of a novel, automated, digital therapeutics, virtual reality, psychological intervention for pain (DTxP). We conducted a 3-arm, prospective, double-blind, pilot, randomized, controlled trial comparing DTxP with a sham placebo comparator and an open-label standard care. Participants were enrolled for 6 to 8 weeks, after which, the standard care control arm were rerandomized to receive either the DTxP or sham placebo. Forty-two participants completed assessments at baseline, immediately posttreatment (6-8 weeks), 9-week, and 5-month follow-up. We found that participants in the DTxP group reported greater reductions in fear of movement and better global impression of change when compared with sham placebo and standard care post treatment. No other group differences were noted at posttreatment or follow-up. When compared with baseline, participants in the DTxP group reported lower disability at 5-month follow-up, lower pain interference and fear of movement post treatment and follow-up, and lower pain intensity at posttreatment. The sham placebo group also reported lower disability and fear of movement at 5-month follow-up compared with baseline. Standard care did not report any significant changes. There were a number of adverse events, with one participant reporting a serious adverse event in the sham placebo, which was not related to treatment. No substantial changes in medications were noted, and participants in the DTxP group reported positive gaming experiences.
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发表时间: 2018-12
期刊: Pain
影响因子: 7.4
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发表时间: 2018-10-30
影响因子: 5.3
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DOI: 10.2196/11973
发表时间: 2019-01-31
期刊: JMIR MENTAL HEALTH
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