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使用远程传授的春森林气功™减轻脊髓损伤成人的神经性疼痛:一项非随机对照试验。

Using remotely delivered Spring Forest Qigong™ to reduce neuropathic pain in adults with spinal cord injury: A non-randomized controlled trial.

作者信息

Van de Winckel Ann, Carpentier Sydney T, Deng Wei, Zhang Lin, Philippus Angela, Monden Kimberley R, Battaglino Ricardo, Morse Leslie R

出版信息

medRxiv. 2023 Feb 15:2023.02.11.23285793. doi: 10.1101/2023.02.11.23285793.

Abstract

IMPORTANCE

The manuscript proposes the feasibility and potential of a remote Qigong intervention to reduce neuropathic pain in adults with spinal cord injury (SCI)-related neuropathic pain.

OBJECTIVE

We determined the feasibility and estimates of efficacy of a remotely delivered Qigong intervention in adults with SCI-related neuropathic pain.

DESIGN

This is a non-randomized controlled trial with outcomes assessed at baseline-, 6- and 12-weeks of Qigong practice, and at 6-weeks and 1-year follow-up.

SETTING

Completely remote clinical trial.

PARTICIPANTS

Adults with SCI-related neuropathic pain, with SCI ≥3 months, with complete or incomplete SCI, and highest neuropathic pain level of >3 on the Numeric Pain Rating Scale (NPRS). We used nationwide volunteer sampling.We recruited 23 adults with chronic SCI (7/2021-2/2022). Eighteen participants started the study and completed all study components, including the 6-week follow-up. Twelve participants completed the 1-year follow-up assessment.

INTERVENTION

Participants practiced the Spring Forest Qigong™ "Five Element Healing Movements" with an online video by combining movement with kinesthetic imagery, at least 3x/week for 12 weeks.

MAIN OUTCOMES AND MEASURES

To address the feasibility outcome and track adherence, the website automatically monitored the days and duration that the Qigong video was played. Self-report neuropathic pain intensity and SCI-related symptoms such as spasms, functional performance, mood, and body appreciation were also collected.

RESULTS

Eighteen participants, 60±12 years of age, 15±11 years post-SCI had a highest baseline of 7.94±2.33 on the NPRS, which was reduced to 4.17±3.07 after 12 weeks of Qigong practice (Cohen's =1.75). This pain relief remained at 6-week and 1-year follow-ups. Participants reported reduced spasm frequency (change score 1.17±1.20, =0.98) and severity (0.72±1.02, =0.71), and reduced interference of neuropathic pain on mood (3.44±2.53, =1.36), sleep (3.39±2.40, =1.41), and daily activities (3.17±2.77, =1.14). They had a greater ability to perform functional activities (Patient Specific Functional Scale, 6.68±3.07, =2.18) and had improved mood (Patient Health Questionnaire-9, 2.33±3.31, =0.70).

CONCLUSIONS AND RELEVANCE

Our preliminary data demonstrate the feasibility of Qigong practice in adults with SCI-related neuropathic pain and promising results of neuropathic pain relief and improvement in SCI-related symptoms after Qigong practice.

TRIAL REGISTRATION THIS MANUSCRIPT REFERS TO THE QUASI-EXPERIMENTAL SUBSTUDY: CREATION: A Clinical Trial of Qigong for Neuropathic Pain Relief in Adults with Spinal Cord Injury, NCT04917107 , https://www.clinicaltrials.gov/ct2/show/NCT04917107 .

摘要

重要性

该手稿提出了一种远程气功干预措施对减轻脊髓损伤(SCI)相关神经性疼痛的成年人神经性疼痛的可行性和潜力。

目的

我们确定了远程提供的气功干预措施对患有SCI相关神经性疼痛的成年人的可行性和疗效评估。

设计

这是一项非随机对照试验,在气功练习的基线、6周和12周以及6周和1年随访时评估结果。

地点

完全远程临床试验。

参与者

患有SCI相关神经性疼痛的成年人,SCI病程≥3个月,完全或不完全性SCI,数字疼痛评分量表(NPRS)上最高神经性疼痛水平>3。我们采用全国范围内的志愿者抽样。我们招募了23名患有慢性SCI的成年人(2021年7月至2022年2月)。18名参与者开始研究并完成了所有研究内容,包括6周随访。12名参与者完成了1年随访评估。

干预措施

参与者通过在线视频练习春林气功™“五行康复动作”,将动作与动觉意象相结合,每周至少练习3次,共12周。

主要结局和测量指标

为了评估可行性结果并跟踪依从性,网站自动监测气功视频的播放天数和时长。还收集了自我报告的神经性疼痛强度以及SCI相关症状,如痉挛、功能表现、情绪和身体感知。

结果

18名参与者,年龄60±12岁,SCI后15±11年,基线时NPRS最高评分为7.94±2.33,气功练习12周后降至4.17±3.07(科恩d值=1.75)。这种疼痛缓解在6周和1年随访时仍持续存在。参与者报告痉挛频率(变化得分1.17±1.20,d值=0.98)和严重程度(0.72±1.02,d值=0.71)降低,神经性疼痛对情绪(3.44±2.53,d值=1.36)、睡眠(3.39±2.40,d值=1.41)和日常活动(3.17±2.77,d值=1.14)的干扰减少。他们进行功能活动的能力更强(患者特定功能量表,6.68±3.07,d值=2.18),情绪改善(患者健康问卷-9,2.33±3.31,d值=0.70)。

结论及相关性

我们的初步数据证明了气功练习对患有SCI相关神经性疼痛的成年人的可行性,以及气功练习后神经性疼痛缓解和SCI相关症状改善的良好结果。

试验注册 本手稿涉及准实验性子研究:创建:一项针对脊髓损伤成年人气功缓解神经性疼痛的临床试验,NCT04917107,https://www.clinicaltrials.gov/ct2/show/NCT04917107

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