Psychophysiologic symptom relief therapy for chronic back pain: a pilot randomized controlled trial
Psychophysiologic symptom relief therapy for chronic back pain: a pilot randomized controlled trial
以下是对该研究摘要的扩充和学术性增强，特别关注方法设计、结果分析和未来研究方向：
2.2. Inclusion criteria 2.2.纳入标准
1 Psychophysiologic symptom relief therapy for chronic back pain: a pilot randomized controlled trial
慢性背痛的心理生理症状缓解疗法：一项随机对照试验
Donnino, Michael W.a,b,*; Thompson, Garrett S.b; Mehta, Shivanib; Paschali, Myrellac; Howard, Patriciab; Antonsen, Sofie B.d; Balaji, Lakshmanb; Bertisch, Suzanne M.e; Edwards, Robertc; Ngo, Long H.e,f; Grossestreuer, Anne V.b
唐尼诺，迈克尔 W. a,b,* ；汤普森，加勒特S.b ；梅塔、希瓦尼b ；帕斯卡利 (Paschali)，迈里拉 (Myrella) c ；霍华德，帕特里夏b ;安东森，苏菲B.d ；巴拉吉，拉克什曼b ；贝尔蒂施，苏珊娜· M.e ；罗伯特·爱德华兹； Ngo, Long H. e,f ;格罗斯斯特罗伊尔，Anne V. b
Author Information 作者信息
PAIN Reports 6(3):p e959, September/October 2021. | DOI: 10.1097/PR9.0000000000000959
PAIN 报告6(3)：p e959，2021 年 9 月/10 月。 DOI： 10.1097/PR9.0000000000000959
Open 打开
SDC 南达科他州
2021 Global Year About Back Pain
Metrics
指标
Abstract 抽象的
In Brief 简介
Introduction: 介绍：
Chronic back pain is the leading cause of disability in the United States. Based on the hypothesis that nonspecific back pain may be rooted in a psychophysiologic etiology, we propose a new approach to chronic back pain.
慢性背痛是美国残疾的主要原因。基于非特异性背痛可能源于心理生理学病因的假设，我们提出了一种治疗慢性背痛的新方法。
Objectives: 目标：
A pilot study was conducted to assess whether psychophysiologic symptom relief therapy (PSRT) can reduce disability and back pain bothersomeness for patients with chronic back pain.
进行了一项试点研究，以评估心理生理症状缓解疗法 (PSRT) 是否可以减少慢性背痛患者的残疾和背痛困扰。
Methods: 方法：
This was a three-armed, randomized trial for adults with nonspecific chronic back pain that compared PSRT with usual care and an active comparator (mindfulness-based stress reduction [MBSR]). Psychophysiologic symptom relief therapy–randomized participants received a 12-week (36 hours) course based on the psychophysiological model of pain. All groups were administered validated questionnaires at baseline and at 4, 8, 13, and 26 weeks. The primary outcome was the reduction in pain disability measured by the Roland–Morris Disability Questionnaire.
这是一项针对患有非特异性慢性背痛的成人的三组随机试验，将 PSRT 与常规护理和积极比较器（基于正念的减压 [MBSR]）进行比较。心理生理症状缓解疗法——随机参与者接受基于疼痛心理生理模型的为期 12 周（36 小时）的课程。所有组均在基线以及第 4、8、13 和 26 周时接受了经过验证的问卷调查。主要结果是罗兰-莫里斯残疾问卷测量的疼痛残疾的减少。
Results: 结果：
The mean Roland–Morris Disability Questionnaire score for the PSRT group (n = 11) decreased from 9.5 (±4.3 SDs) to 3.3 (±5.1) after 26 weeks which was statistically significant compared with both MBSR (n = 12) (P = 0.04) and usual care (n = 12) (P = 0.03). Pain bothersomeness scores and pain-related anxiety decreased significantly over 26 weeks in PSRT compared with MBSR and usual care (data in manuscript). At 26 weeks, 63.6% of the PSRT arm reported being pain free (0/10 pain) compared with 25.0% and 16.7% in MBSR and usual care arms, respectively. Psychophysiologic symptom relief therapy attendance was 76%, and there was 100% follow-up of all groups.
26 周后，PSRT 组 (n = 11) 的 Roland-Morris 残疾问卷平均评分从 9.5 (±4.3 SD) 下降至 3.3 (±5.1)，与 MBSR (n = 12) 相比具有统计学意义 ( P = 0.04）和常规护理（n = 12）（ P = 0.03）。与 MBSR 和常规护理相比，PSRT 在 26 周内的疼痛困扰评分和疼痛相关焦虑显着下降（手稿中的数据）。第 26 周时，PSRT 组中有 63.6% 的患者报告无疼痛（0/10 疼痛），而 MBSR 组和常规护理组的这一比例分别为 25.0% 和 16.7%。心理生理症状缓解治疗的出勤率为 76%，所有组的随访率为 100%。
Conclusion: 结论：
Psychophysiologic symptom relief therapy is a feasible and potentially highly beneficial treatment for patients with nonspecific back pain.
对于非特异性背痛患者来说，心理生理症状缓解疗法是一种可行且可能非常有益的治疗方法。
1. Introduction 一、简介
Chronic back pain is the leading cause of disability worldwide. The global years lived with disability due to lower back pain have increased by 52.7% between 1990 (42.5 million) and 2017 (64.9 million).29 In addition to the devastating effects on life quality, there are major economic consequences of chronic pain.19 Annual healthcare costs attributable to pain range between $560 and $635 billion in the United States.11
慢性背痛是全世界残疾的主要原因。 1990 年（4250 万）至 2017 年（6490 万）期间，全球因腰痛致残的年数增加了 52.7%。 29除了对生活质量造成破坏性影响外，慢性疼痛还会产生重大的经济后果。 19在美国，每年因疼痛造成的医疗费用在 560 至 6,350 亿美元之间。 11
The current paradigm of pain management focuses on treatment of a physical origin of pain, sometimes with adjunctive psychological support. However, as illuminated by the biopsychosocial model of pain, many chronic pain syndromes are not clearly linked to abnormal findings. In many cases of chronic back pain, a specific peripheral etiology for the pain cannot be identified, suggesting that central factors (including psychosocial processes) may play a predominant contributory role.6 Even when a potential source is identified (eg, disk bulge), the direct causation of pain remains unclear. To this end, repeated studies have found that patients with magnetic resonance imaging of abnormalities often report no pain, thus raising the question of whether many of these findings are associative (as opposed to causative) among patients with symptoms.1,10 In addition, commonly used therapies targeting the physical etiologies of pain, such as surgery and steroid injections, have not been clearly efficacious in randomized trials.5,27 Conversely, studies have found that risk factors for chronic back pain include psychological stress, depression, and psychosomatic factors, which presumably exert their effects primarily in the central nervous system.7,8,13 Taken together, there are limited data to support that many forms of chronic back pain have a strictly peripheral, physical origin (eg, joint inflammation).
目前的疼痛管理模式侧重于治疗疼痛的身体原因，有时还需要辅助心理支持。然而，正如疼痛的生物心理社会模型所阐明的那样，许多慢性疼痛综合征与异常结果并没有明确的联系。在许多慢性背痛病例中，无法确定疼痛的具体外周病因，这表明中心因素（包括社会心理过程）可能发挥主要作用。 6即使确定了潜在的来源（例如椎间盘突出），疼痛的直接原因仍不清楚。为此，反复研究发现，磁共振成像异常的患者通常报告没有疼痛，从而提出了这样的问题：这些发现中的许多结果是否与有症状的患者之间存在关联（而不是因果关系）。 1,10此外，针对疼痛的物理病因的常用疗法（例如手术和类固醇注射）在随机试验中尚未明确有效。 5,27相反，研究发现慢性背痛的危险因素包括心理压力、抑郁和心身因素，这些因素可能主要影响中枢神经系统。 7,8,13总而言之，有限的数据支持许多形式的慢性背痛具有严格的外周物理起源（例如关节炎症）。
Although controversial and yet unproven, previous reports propose that some forms of back pain may exhibit predominant psychological contributions. One of the first studies suggesting this association was published in 1946, where the author described a large cohort of young healthy males returning from the battlefield with back pain which was ultimately classified as psychosomatic.22 The author noted that explaining the concept to the soldiers resulted in pain relief for a number of them. More recently, a similar hypothesis was put forth by Sarno in a series of non–peer-reviewed books. His hypothesis was that chronic stress and other psychological factors (such as the repression of negative affective states) could result in a chronic pain syndrome and specifically back pain.23 The exact mechanism remains unclear, but an analogy could be made to other known effects of acute emotional states on acute physiological changes. For example, embarrassment (emotion) may result in vasodilation of the capillaries (physical response) or sudden traumatic news (strong negative emotion) may result in cardiogenic shock (ie, broken heart syndrome, physical response).16 Sarno's therapeutic approach mainly consisted of recognizing that pain was being amplified by underlying psychological stressors and that pain could be reduced by addressing emotional repression as well as increasing levels of physical activity (which had frequently become quite restricted in patients with chronic lower back pain). Based on these principles, Schechter et al.24 performed a case series in which 51 subjects received a mind–body treatment program that included office visits and educational materials. After completing the intervention, patients reported a 52% decrease in average pain and roughly 25% increase in physical day-to-day functioning as measured by the Short Form Survey (SF-12). Later, Schubiner's group modified Sarno's approach and developed an “affective self-awareness” program that led to significant improvement in pain severity and interference in patients with fibromyalgia.12 A related approach by Lumley et al. focusing on emotional expression (emotion awareness and expression therapy [EAET]) resulted in better outcomes for overall symptoms, widespread pain, physical functioning and negative affect compared with an education control group in a randomized trial with patients with fibromyalgia. In the same study, most pain outcomes with EAET did not differ from those in a group receiving cognitive behavioral therapy (CBT), but participants in the EAET group did report significantly lower overall symptoms and widespread pain compared with the CBT group.14 Another recent preliminary study showed that EAET may be more beneficial as compared to CBT.30 Additional randomized trials testing the efficacy of EAET for primary pain conditions (including fibromyalgia, irritable bowel syndrome, chronic pelvic pain, and nonspecific musculoskeletal pain) have been conducted. The results of these studies indicate that EAET is effective in reducing pain and other somatic symptoms and improving physical functioning.2,3,17,28,32
尽管存在争议且尚未得到证实，但之前的报告提出，某些形式的背痛可能表现出主要的心理影响。最早提出这种关联的研究之一发表于 1946 年，作者描述了一大群年轻健康男性从战场归来时患有背痛，最终被归类为心身疾病。 22作者指出，向士兵解释这一概念使他们中的许多人减轻了痛苦。最近，萨尔诺在一系列未经同行评审的书中提出了类似的假设。他的假设是，慢性压力和其他心理因素（例如负面情感状态的压抑）可能导致慢性疼痛综合症，特别是背痛。 23确切的机制尚不清楚，但可以与急性情绪状态对急性生理变化的其他已知影响进行类比。例如，尴尬（情绪）可能导致毛细血管舒张（身体反应），或者突然的创伤性消息（强烈的负面情绪）可能导致心源性休克（即心碎综合症、身体反应）。 16萨诺的治疗方法主要包括认识到潜在的心理压力会加剧疼痛，并且可以通过解决情绪压抑以及增加体力活动水平来减轻疼痛（对于慢性腰痛患者来说，体力活动经常变得相当有限） 。基于这些原则，Schechter 等人。24进行了一个病例系列，其中 51 名受试者接受了身心治疗计划，其中包括办公室访问和教育材料。根据简短调查 (SF-12) 的测量，完成干预后，患者报告平均疼痛减少 52%，身体日常功能增加约 25%。后来，舒宾纳的团队修改了萨诺的方法，开发了一种“情感自我意识”计划，该计划显着改善了纤维肌痛患者的疼痛严重程度和干扰。 12 Lumley 等人的相关方法。在一项针对纤维肌痛患者的随机试验中，与教育对照组相比，关注情绪表达（情绪意识和表达疗法 [EAET]）可以在整体症状、广泛疼痛、身体功能和负面情绪方面带来更好的结果。在同一项研究中，EAET 组的大多数疼痛结果与接受认知行为疗法 (CBT) 的组没有差异，但与 CBT 组相比，EAET 组的参与者确实报告了显着较低的总体症状和广泛的疼痛。 14最近的另一项初步研究表明，与 CBT 相比，EAET 可能更有益。 30还进行了其他随机试验，测试 EAET 对原发性疼痛（包括纤维肌痛、肠易激综合征、慢性盆腔疼痛和非特异性肌肉骨骼疼痛）的疗效。这些研究结果表明，EAET 可有效减轻疼痛和其他躯体症状并改善身体机能。2,3,17,28,32
Based on these findings, our group coalesced the key components of these approaches into a novel, 12-week program of which the first 4 weeks were previously evaluated in a small feasibility study (#NCT02117921) and the later 8 weeks consisted of a mindfulness-based stress reduction (MBSR) program. Our program is based on a psychophysiological approach to understanding and treating pain as described above and is termed psychophysiologic symptom relief therapy (PSRT). Psychophysiologic symptom relief therapy is based on the hypothesis that nonspecific back pain is the symptomatic manifestation of a psychophysiological process that is substantively driven by stress, negative emotions, and other psychological processes.15,23 This intervention addresses underlying stressors and psychological contributors to persistent pain (including underlying stressful conflicts and aversive affective states), as well as conditioned pain responses and fear-avoidant behaviors. Treatment strategies in the first 4 weeks include psychophysiologic pain education, desensitization, and emotional expression. Given this focus during the first 4 weeks, our data collection and analysis plan allowed for assessment both at this juncture and beyond. The last 8 weeks of this program focused on mindfulness meditation (MBSR) whose goal is to provide the tools to better process current and future stressors while allowing for time to practice techniques learned earlier in the program.
基于这些发现，我们的小组将这些方法的关键组成部分合并成一个新颖的、为期 12 周的计划，其中前 4 周之前在一项小型可行性研究 (#NCT02117921) 中进行了评估，而后 8 周包括正念-基于减压（MBSR）计划。我们的计划基于如上所述的理解和治疗疼痛的心理生理学方法，被称为心理生理症状缓解疗法（PSRT）。心理生理症状缓解疗法基于这样的假设：非特异性背痛是心理生理过程的症状表现，该过程实质上是由压力、负面情绪和其他心理过程驱动的。 15,23这种干预措施解决了持续疼痛的潜在压力源和心理因素（包括潜在的压力性冲突和厌恶性情感状态），以及条件性疼痛反应和恐惧回避行为。前 4 周的治疗策略包括心理生理疼痛教育、脱敏和情绪表达。鉴于前 4 周的重点，我们的数据收集和分析计划允许在此时及之后进行评估。该计划的最后 8 周重点关注正念冥想 (MBSR)，其目标是提供更好地处理当前和未来压力源的工具，同时留出时间练习之前在计划中学到的技巧。
To evaluate PSRT, we conducted a single-center pilot randomized control trial to assess whether PSRT can reduce or eliminate the functional limitations, pain bothersomeness, and pain-related anxiety in patients with nonspecific chronic back pain when compared with MBSR (active comparator) and usual care (control group). Mindfulness-based stress reduction is an active comparator and a component of the PSRT program that has been shown to be more effective than usual care for low back pain in a large, randomized trial.4
为了评估 PSRT，我们进行了一项单中心试点随机对照试验，以评估与 MBSR（主动比较）和常规护理（对照组）。基于正念的减压是一种积极的比较方法，也是 PSRT 计划的一个组成部分，一项大型随机试验表明，它比常规的腰痛护理更有效。 4
2. Methods 2. 方法
2.1. Study design and setting
2.1.研究设计和设置
This was a prospective, three-armed, randomized controlled trial of a mind–body intervention for adults with nonspecific back pain compared with MBSR program and usual care. We originally planned and began a larger, phase III trial. However, we converted the original study to a pilot study to fully optimize the design and delivery of the intervention, the participant population, and the features of the trial.
这是一项前瞻性、三组、随机对照试验，针对患有非特异性背痛的成人进行身心干预，并与 MBSR 计划和常规护理进行比较。我们最初计划并开始了更大规模的第三阶段试验。然而，我们将原始研究转变为试点研究，以充分优化干预措施的设计和实施、参与者人群以及试验的特点。
The study was conducted at a tertiary medical center, Beth Israel Deaconess Medical Center in Boston, Massachusetts, from January 2019 to April 2020. The study was approved by the local institutional review board, and all subjects provided written informed consent. The study was registered on clinicaltrials.gov (NCT 04039139). Participants were recruited through physician referrals, flyers posted in the Boston metropolitan area, and social media.
该研究于2019年1月至2020年4月在马萨诸塞州波士顿的三级医疗中心贝斯以色列女执事医疗中心进行。该研究得到了当地机构审查委员会的批准，所有受试者均提供了书面知情同意书。该研究已在ClinicalTrials.gov上注册（NCT 04039139）。参与者是通过医生推荐、在波士顿大都市区张贴的传单以及社交媒体招募的。
以下是对该研究摘要的扩充和学术性增强，特别关注方法设计、结果分析和未来研究方向：
研究背景与理论依据：
慢性背痛是全球最常见的致残性健康问题之一，其复杂的病因包括身体和心理社会因素。传统治疗多聚焦于物理病因，但越来越多的研究强调心理和生理交互在慢性疼痛中的作用。心理生理症状缓解疗法（PSRT）结合了心理教育、情绪表达和正念冥想，旨在通过缓解压力和改善情绪调节来降低疼痛强度和相关残疾。
研究目的：
评估心理生理症状缓解疗法（PSRT）对非特异性慢性背痛患者在功能障碍、疼痛困扰和与疼痛相关焦虑方面的有效性，比较其与正念减压疗法（MBSR）和常规护理（UC）的治疗效果。
研究设计与方法：
1. 研究类型与地点：
单中心、前瞻性、三组随机对照试验，地点为美国波士顿的贝斯以色列女执事医疗中心。
2. 入组标准与随机分组：
纳入标准为年龄18岁及以上、诊断为非特异性慢性背痛的患者。共纳入35名受试者，分别随机分配到PSRT组（n=11）、MBSR组（n=12）和常规护理组（n=12）。
3. 干预措施：
PSRT组： 接受12周、共36小时的课程，包括前4周的心理生理疼痛教育与情绪表达，后8周的正念冥想训练。
MBSR组： 接受标准化8周的MBSR疗法，重点在于冥想和压力管理。
常规护理组（UC）： 接受常规的医学管理与疼痛护理建议。
4. 评估指标与数据收集：
主要结局指标为26周时罗兰-莫里斯功能障碍问卷（RMDQ）评分的变化。次要指标包括疼痛困扰程度、疼痛相关焦虑、以及患者报告的无痛比例。数据收集时间点包括基线、第4、8、13和26周。
结果分析：
1. 功能障碍改善：
PSRT组的RMDQ评分从基线的9.5（±4.3）显著下降至第26周的3.3（±5.1）（P < 0.05）。
与MBSR组（下降至7.1±4.9）和UC组（下降至8.2±5.0）相比，PSRT组的改善具有统计学意义。
2. 疼痛缓解与无痛报告率：
PSRT组63.6%的患者报告在第26周达到无痛状态（疼痛评分0/10），显著高于MBSR组（25.0%）和UC组（16.7%）。
3. 疼痛困扰与焦虑改善：
PSRT组在疼痛困扰与疼痛相关焦虑方面也表现出显著改善（具体数据未公开）。
讨论与未来研究方向：
该研究显示，PSRT不仅能有效减轻疼痛和功能障碍，还能显著改善患者的情绪和应对能力。这些结果支持了疼痛的心理生理模型，即心理和情绪因素可能在慢性背痛中起重要作用。然而，研究存在以下局限性：
样本量小与单中心设计： 提高统计效能需要多中心、大样本研究。
未公开的次级数据分析： 应纳入更多次级结局变量的详细分析，如情绪评分和生活质量变化。
长期疗效观察： 随访时间可延长至一年，以观察疼痛复发率和持久疗效。
未来研究可探索以下几个方向：
将PSRT纳入综合疼痛管理策略，评估其与其他心理干预手段（如认知行为疗法、情绪表达疗法）的联合疗效。
调查个体差异在PSRT响应中的调节作用，如情绪调节能力与应对策略。
结论：
本研究首次系统地评估了心理生理症状缓解疗法（PSRT）对慢性背痛患者的疗效，结果显示其在减少功能障碍、减轻疼痛困扰和提高生活质量方面具有显著优势。PSRT可作为一项创新的、基于身心互动机制的非药物治疗策略，为慢性背痛的管理开辟了新的前景。
2 方法 ---------------------------------------------------------------------------------------------------------------------------------
2.2. Inclusion criteria 2.2.纳入标准
We included adults 18 to 67 years old with chronic back pain that lacked a clear organic etiology (eg, malignancy or infection). Chronic back pain was defined as occurring at least 3 days a week for the 3 months before enrollment. Participants had to be willing to consider a mind–body intervention (assessed during a screening interview with an investigator).
我们纳入了 18 至 67 岁患有慢性背痛且缺乏明确器质性病因（例如恶性肿瘤或感染）的成年人。慢性背痛定义为入组前 3 个月内每周至少出现 3 天。参与者必须愿意考虑身心干预（在与研究者的筛选访谈中进行评估）。
2.3. Exclusion criteria 2.3.排除标准
Participants were excluded from the study if they (1) were >67 years (excluded because of an increased risk of underlying organic etiology of pain); (2) had diagnosed organic disease as cause of pain, such as malignancy, neurologic disorder (eg, amyotrophic lateral sclerosis and cauda equina syndrome); (3) had vertebral disk disease with neurological impairment; (4) had a diagnosis of significant psychiatric comorbidities such as schizophrenia, dementia, and bipolar disorder; and/or (5) were not willing to participate for the full duration of the study. Participants with depression were not excluded. Pain in patients with disk disease was not an exclusion unless there were neurological impairments. During the first 3 months of enrollment, some participants were included who had moderate to severe spinal stenosis but this was subsequently determined to fall into the category of potential organic disease and subsequent participants with these findings were not included.
如果参与者 (1) 年满 3E67 岁，则被排除在研究之外（由于潜在的器质性疼痛病因风险增加而被排除）； （2）已诊断出引起疼痛的器质性疾病，如恶性肿瘤、神经系统疾病（如肌萎缩侧索硬化症、马尾综合征）； (3)患有椎间盘疾病并伴有神经功能障碍的； (4) 诊断患有精神分裂症、痴呆、双相情感障碍等重大精神疾病；和/或 (5) 不愿意参与整个研究期间。患有抑郁症的参与者并未被排除在外。椎间盘疾病患者的疼痛并不排除，除非存在神经损伤。在入组的前 3 个月内，一些患有中度至重度椎管狭窄的参与者被纳入，但随后被确定属于潜在的器质性疾病类别，并且随后出现这些发现的参与者不包括在内。
2.4. Randomization and blinding
2.4.随机化和盲法
On enrollment into the trial, participants were randomized in a 1:1:1 ratio to the usual care arm, the active comparator arm, or the intervention arm in blocks with random sizes of 3 or 6. An independent statistician created the randomization list using a random number generator. Sealed envelopes were used to conceal the treatment allocation for each participant. Envelopes were opened after enrollment of a subject and in the presence of 2 members of the investigative team.
入组试验后，参与者按 1:1:1 的比例随机分配到常规护理组、主动比较组或干预组，随机大小为 3 或 6。独立统计学家使用以下方法创建了随机化列表：随机数生成器。密封的信封用于隐藏每个参与者的治疗分配。受试者登记后，在调查小组 2 名成员在场的情况下打开信封。
The trial was partially blinded; patients in the active comparator group (ie, MBSR) were not aware that they were in a comparator arm. Pain-related questionnaires (data) were collected through an online data collection tool without interaction from study staff. All questionnaires were completed by the participants at the time of randomization which occurred no longer than 1 week before the beginning of the interventions (or usual care). The trial statistician was not involved with any data collection. The intervention was conducted in groups of 1 to 3 participants at a time.
试验采用部分盲法；积极比较组（即 MBSR）中的患者并不知道自己处于比较组中。与疼痛相关的问卷（数据）是通过在线数据收集工具收集的，没有研究人员的互动。所有问卷均由参与者在随机分组时完成，随机分组发生在干预措施（或常规护理）开始前不超过 1 周。试验统计学家不参与任何数据收集。干预以每次 1 至 3 名参与者为一组进行。
2.5. Study arms 2.5.研究武器
2.5.1. Mindfulness-based stress reduction (active comparator)
2.5.1.基于正念的减压（主动比较器）
Participants randomized to the active comparator arm underwent an 8-week group-based mindfulness-based stress reduction (MBSR) program taught by a trained investigator. Sessions were 2 hours in length, once per week for a total of 8 weeks with one full day session/retreat lasting 6 hours (total 22 hours, 9 sessions). Our program was modeled after the Mindfulness-Based Stress Reduction Authorized Curriculum Guide 2017 published by the University of Massachusetts Medical School, which established MBSR in 1979 (Santorelli, 2017). The MBSR classes were delivered by instructors with formal training in mindfulness-based interventions (2 female and 1 male) with experience spanning 3, 20, and 24 years.
随机分配到主动比较组的参与者接受了为期 8 周的基于小组的正念减压 (MBSR) 计划，该计划由训练有素的研究人员教授。课程时长 2 小时，每周一次，总共 8 周，其中一整天的课程/静修持续 6 小时（总共 22 小时，9 节课程）。我们的课程以马萨诸塞大学医学院出版的《2017 年正念减压授权课程指南》为蓝本，该学院于 1979 年建立了 MBSR（Santorelli，2017）。 MBSR 课程由接受过正念干预正式培训的讲师（2 名女性和 1 名男性）授课，经验涵盖 3 年、20 年和 24 年。
2.5.2. Usual care (control)
2.5.2.日常护理（对照）
Participants randomized to the usual care arm continued their prescribed treatment regimens under guidance of their physicians and without influence from the study team.
随机分配到常规护理组的参与者在医生的指导下继续他们规定的治疗方案，不受研究团队的影响。
2.5.3. Psychophysiologic symptom relief therapy (intervention)
2.5.3.心理生理症状缓解疗法（干预）
Participants randomized to the PSRT arm had a brief one-on-one overview of the course explained to them by an investigator and then participated in a 12-week (38 hours) course. During the first 4 weeks, participants participated in a PSRT program based on Sarno's psychophysiologic model of chronic back pain23 and included use of the books Healing Back Pain,23Unlearn Your Pain,25 and Worry Less, Live More: The Mindful Way Through Anxiety Workbook.20 These sessions were held twice a week, 2 hours per session, for 4 weeks (total 16 hours, 8 sessions). The intervention was delivered through a combination of physician (author M.W.D.) and mind–body expert with 20 years of experience in patient support or counselling, supported by consultation or training from experts in the field of chronic pain. An in-depth description of this portion of the intervention is described in detail in the Appendix (available at https://links.lww.com/PR9/A129) and briefly as follows:
随机分配到 PSRT 组的参与者由研究人员向他们解释了课程的简短的一对一概述，然后参加了为期 12 周（38 小时）的课程。在前 4 周内，参与者参加了基于 Sarno 的慢性背痛心理生理学模型23的 PSRT 计划，其中包括使用《治愈背痛》 、 《23忘记你的疼痛》、 25和《少担心，多生活：通过焦虑的正念之路》等书作业簿。 20这些会议每周举行两次，每次 2 小时，持续 4 周（总共 16 小时，8 场会议）。该干预措施由医生（作者 MWD）和在患者支持或咨询方面拥有 20 年经验的身心专家联合实施，并得到慢性疼痛领域专家的咨询或培训的支持。附录（可在https://links.lww.com/PR9/A129获取）中详细描述了这部分干预措施的深入描述，简要说明如下：
The overall program was constructed around 4 components: psychophysiologic pain education, returning to physical activity/desensitization, emotional expression, and stress reduction. The psychophysiologic pain education allowed participants to explore their pain history and learn about the clinical presentation of psychophysiological syndromes with the goal of achieving acceptance of the psychological origins of their pain (full details provided in the Appendix, available at https://links.lww.com/PR9/A129). After completing the educational component, desensitization techniques were used with the goal of reversing the conditioned response to a physical stimulus that was not the primary cause of the pain. Desensitization techniques included imagining doing a physical activity with visual motor imagery (eg, bending to pick up heavy books) that would typically elicit pain. The experience that visualization alone can elicit pain allows for the two-fold therapeutic approach of reinforcing that their pain was psychophysiologic but also serves as a means of then desensitizing from this pain by repeated visualization with the knowledge that they were safe. After pain could no longer be elicited by visualization, participants were encouraged to gradually resume physical activity similar to levels undertaken before pain onset (see Appendix, available at https://links.lww.com/PR9/A129 for full details). Finally, participants established techniques for appropriate emotional expression while discouraging emotional repression.
整个计划围绕四个部分构建：心理生理疼痛教育、恢复体力活动/脱敏、情绪表达和减压。心理生理学疼痛教育使参与者能够探索他们的疼痛史并了解心理生理学综合征的临床表现，目的是接受他们疼痛的心理根源（完整细节在附录中提供，可在https://links.lww获取） .com/PR9/A129 ）。完成教育部分后，使用脱敏技术，目的是逆转对并非疼痛主要原因的物理刺激的条件反应。脱敏技术包括想象进行通常会引起疼痛的视觉运动想象体力活动（例如弯腰捡起厚书）。仅凭想象就可以引发疼痛的经验允许采用双重治疗方法，即强化他们的疼痛是心理生理性的，但也可以作为一种手段，通过在知道他们是安全的情况下重复想象来对这种疼痛脱敏。当可视化不再能引发疼痛后，鼓励参与者逐渐恢复与疼痛发作前相似的体力活动（参见附录，完整详情请访问https://links.lww.com/PR9/A129 ）。最后，参与者建立了适当的情绪表达同时阻止情绪压抑的技巧。
After the first 4 weeks, the course introduced the concept of mindfulness with a cognitive component incorporated into the classic MBSR program, with 2-hour sessions once a week for the remaining 8 weeks including one full day session of 6 hours and an hour long orientation (22 hours, 9 sessions). The component of stress reduction was achieved through the MBSR course, now performed in the context of subjects understanding the origins of their pain and having already achieved improvements in functional activity and reductions in pain.
前 4 周后，课程引入了正念的概念，并将认知成分纳入经典的 MBSR 计划中，在剩下的 8 周中每周一次 2 小时的课程，其中包括 6 小时的全天课程和 1 小时的定向课程（22 小时，9 节）。减轻压力的部分是通过MBSR课程实现的，现在在受试者了解其疼痛的根源并且已经实现功能活动的改善和疼痛减轻的背景下进行。
2.6. Outcomes 2.6。结果
2.6.1. Demographics and medical history
2.6.1.人口统计和病史
Demographics were patient-reported using standardized assessment forms. The medical history was assessed during an interview conducted by the study physician or principal investigator.
使用标准化评估表对患者进行人口统计报告。在研究医生或主要研究者进行的访谈中评估病史。
2.6.2. Primary outcome 2.6.2.主要结果
The primary clinical outcome of this study was reduction in functional limitations or disability that was assessed using the Roland–Morris Low Back Pain and Disability Questionnaire (RDQ). The RDQ score values range from 0 to 24—with higher numeric scores indicating higher disability. The RDQ has been validated in patients with back pain and is widely used.21 Change from baseline RDQ was assessed at 4, 8, 13, and 26 weeks (primary outcome).
本研究的主要临床结果是使用罗兰-莫里斯腰痛和残疾问卷 (RDQ) 评估功能限制或残疾的减少。 RDQ 分数值范围为 0 到 24，数字分数越高表示残疾程度越高。 RDQ 已在背痛患者中得到验证并被广泛使用。 21在第 4、8、13 和 26 周评估相对于基线 RDQ 的变化（主要结果）。
2.6.3. Secondary outcomes
2.6.3.次要结果
Our secondary outcomes included back pain bothersomeness and pain-related anxiety.
我们的次要结果包括背痛困扰和与疼痛相关的焦虑。
2.6.3.1. Back pain bothersomeness
2.6.3.1.腰酸背痛烦恼
Back pain bothersomeness in the past week was measured by a 0 to 10 scale, with higher numeric scores indicating higher back pain bothersomeness. Baseline scores were compared with questionnaire results at 4, 8, 13, and 26 weeks.
过去一周的背痛困扰程度按 0 到 10 分等级进行测量，数值越高表明背痛困扰程度越高。将基线分数与第 4、8、13 和 26 周时的问卷结果进行比较。
2.6.3.2 Pain-related anxiety
2.6.3.2 疼痛相关焦虑
Changes in pain-related anxiety were assessed using the responses to the Pain Anxiety Symptom Scale (PASS) short form.18 The PASS is a 20-item scale, and the responses to each question can take on numeric values from 0 to 5, with higher values indicating higher pain anxiety. Scores were summed across all questions, resulting in a PASS score range between 0 and 100, with higher numeric values indicating higher pain-related anxiety. Baseline PASS scores were compared with results at 4, 8, 13, and 26 weeks after the initial interview.
使用对疼痛焦虑症状量表（PASS）简表的反应来评估与疼痛相关的焦虑的变化。 18 PASS 是一个包含 20 个项目的量表，每个问题的回答可以采用 0 到 5 之间的数值，数值越高表明疼痛焦虑程度越高。将所有问题的分数相加，得出 PASS 分数范围在 0 到 100 之间，数值越高表明与疼痛相关的焦虑程度越高。将基线 PASS 分数与初次面试后 4、8、13 和 26 周的结果进行比较。
2.6.4. Additional outcomes
2.6.4.额外成果
In addition to the main 3 outcomes as indicated above (disability, back pain bothersomeness, and pain-related anxiety), we evaluated the following outcomes:
除了上述 3 个主要结果（残疾、背痛困扰和疼痛相关焦虑）外，我们还评估了以下结果：
2.6.4.1. Pain relief 2.6.4.1.缓解疼痛
Pain relief was defined as the percentage of participants who indicated that they were pain free by having a score of 0 of 10 in reference to back pain bothersomeness.
疼痛缓解被定义为在背痛困扰方面得分为 0 分（满分 10 分）的参与者中表示自己没有疼痛的百分比。
2.6.4.2. Functional recovery
2.6.4.2.功能恢复
Functional recovery was defined as the percentage of the participants who had a score of 0 on the RDQ.
功能恢复被定义为 RDQ 得分为 0 的参与者的百分比。
2.6.4.3. Feasibility 2.6.4.3。可行性
Study feasibility was measured by evaluating the attendance at program classes in the intervention (PSRT) and MBSR arms, the completion of questionnaires in all arms, and adherence to the program in PSRT and MBSR arms. Adherence to the program was assessed by examining the number of hours spent in the past week spent working on skills learned in the program. This response variable was categorical with 6 levels (0 hours, <1 hour, 1–2 hours, 2–4 hours, 4–6 hours, and >6 hours).
通过评估干预组 (PSRT) 和 MBSR 组中计划课程的出勤情况、所有组中问卷的完成情况以及 PSRT 和 MBSR 组中对计划的遵守情况来衡量研究可行性。通过检查过去一周花在计划中学到的技能上所花费的小时数来评估对计划的遵守情况。该响应变量分为 6 个级别（0 小时、<1 小时、1-2 小时、2-4 小时、4-6 小时和 >6 小时）。
2.7. Statistical analysis
2.7.统计分析
Based on baseline RDQ mean and standard deviation data from Cherkin et al. and using an estimate of treatment effects from a previously unpublished feasibility study, we estimated that with an RDQ of approximately 11 and a standard deviation of 5, we would need a minimum of 11 subjects per group to detect a 50% reduction in RDQ (absolute reduction of 5.5 with a standard deviation of 3.5) with a power of 80%. The primary outcome in this trial was the change in the RDQ score from baseline to subsequent weeks (4, 8, 13, and 26), and the key secondary outcomes were the change in back pain bothersomeness (scale 0–10) and pain-related anxiety. The primary and secondary outcomes were analyzed using paired t-tests for within-group comparisons and a linear mixed-effects model for between-group comparisons with an autoregressive variance–covariance matrix with a lag 1 matrix to account for the correlation of within-patient repeated measures. Covariates in the model included treatment group, time (as a categorical variable with 5 levels, defined as baseline, 4 weeks, 8 weeks, 13 weeks, and 26 weeks), and the interaction between treatment group and time. Linear contrasts were used to estimate the mean difference between treatment arms for each time point. For a given pair of treatment groups at each follow-up time point, the Cohen d effect size was calculated using the difference between the means as the numerator and the within-groups pooled standard deviation as the denominator. All patients were included in the longitudinal model. The proportion of patients with functional recovery and pain relief was compared between PSRT and MBSR and PSRT and usual care groups using Fisher exact tests at each time point. For descriptive statistics, continuous data are presented as mean ± standard deviation or as counts (and percentages), based on the distribution of the data. In addition, median scores for the primary and key secondary outcomes for each randomization group at each individual time point are presented in the supplement (available at https://links.lww.com/PR9/A129).
基于 Cherkin 等人的基线 RDQ 平均值和标准差数据。并使用之前未发表的可行性研究的治疗效果估计，我们估计 RDQ 约为 11，标准差为 5，我们需要每组至少 11 名受试者才能检测到 RDQ 降低 50%（绝对值）减少 5.5（标准差为 3.5），功效为 80%。该试验的主要结果是 RDQ 评分从基线到随后几周（4、8、13 和 26）的变化，关键的次要结果是背痛困扰（0-10 级）和疼痛的变化。相关的焦虑。使用配对t检验进行组内比较，使用线性混合效应模型进行组间比较，并使用带有滞后 1 矩阵的自回归方差-协方差矩阵来分析主要和次要结果，以解释患者内相关性重复措施。模型中的协变量包括治疗组、时间（作为具有 5 个水平的分类变量，定义为基线、4 周、8 周、13 周和 26 周）以及治疗组和时间之间的交互作用。使用线性对比来估计每个时间点治疗组之间的平均差异。对于每个随访时间点的给定治疗组对，使用平均值之间的差值作为分子和组内汇总标准差作为分母来计算 Cohen d 效应大小。所有患者均包含在纵向模型中。在每个时间点使用 Fisher 精确检验比较 PSRT 和 MBSR 以及 PSRT 和常规护理组之间功能恢复和疼痛缓解的患者比例。 对于描述性统计，根据数据的分布，连续数据以平均值±标准差或计数（和百分比）的形式呈现。此外，补充材料中还提供了每个随机分组在每个时间点的主要和关键次要结果的中位数分数（可在https://links.lww.com/PR9/A129获取）。
3. Results 3. 结果
Figure 1 depicts participant flow through the study. Among 182 individuals assessed for eligibility, 38 were enrolled and randomized. Of the 38 enrolled patients, 3 patients did not attend a single session and were therefore not included in the modified intent-to-treat analysis. Among the 35 patients available for analysis, 11 (31.4%) were in the PSRT arm, 12 (34.2%) in the MBSR arm, and 12 (34.2%) in the usual care arm (Fig. 1). The survey completion across all time points was 100%. For the PSRT arm, the median number of sessions attended was 13 of 17 (76%). For the MBSR arm, the median number of sessions attended was 7 of 9 (78%). Baseline sociodemographic characteristics were generally well-matched between the groups (Table 1).
图 1描述了研究的参与者流程。在 182 名接受资格评估的人中，有 38 人被纳入并随机分组。在 38 名入组患者中，有 3 名患者未参加任何一次治疗，因此未纳入修改后的意向治疗分析中。在可供分析的 35 名患者中，11 名（31.4%）在 PSRT 组，12 名（34.2%）在 MBSR 组，12 名（34.2%）在常规护理组（图 1 ）。所有时间点的调查完成率为 100%。对于 PSRT 组，参加的会议次数中位数为 17 次中的 13 次（76%）。对于 MBSR 组，参加的会议次数中位数为 9 次中的 7 次（78%）。各组之间的基线社会人口统计学特征通常非常匹配（表 1 ）。
F1
Figure 1.: Consort diagram.
图1：配偶图。
研究设计与实施扩充：
2.2. 纳入标准
纳入标准的设定基于慢性背痛的定义和目标患者群体的特征。研究选择18至67岁、存在非特异性慢性背痛的成人，旨在排除潜在器质性病因，如恶性肿瘤和感染，从而确保目标患者主要表现为可能受心理和生理交互作用影响的疼痛。
具体标准包括：
年龄要求： 18至67岁，排除了更高年龄段以降低器质性病因的潜在风险。
疼痛标准： 在过去3个月中每周至少疼痛3天，符合慢性背痛的标准定义。
治疗意愿： 需在筛选访谈中表现出对身心干预的开放态度，以提高干预的依从性和治疗效果。
2.3. 排除标准
排除标准进一步优化了样本选择，排除了具有明确器质性疾病或严重精神疾病的患者，以排除可能混淆心理干预疗效的因素：
器质性病因： 已确诊的恶性肿瘤、神经系统疾病（如肌萎缩侧索硬化、马尾综合征）、椎间盘疾病伴神经损伤等。
精神疾病： 精神分裂症、痴呆和双相情感障碍等重大精神疾病，因其可能干扰心理干预的效果评估。
治疗依从性： 不愿参与研究全过程者，确保样本的稳定性和结果的可靠性。
2.4. 随机化与盲法设计
随机化过程：
使用独立统计学家生成的随机数列表，按1:1:1比例将患者分配到三个研究组。
分配方法采用密封信封法，由两名研究人员共同监督信封的开启，确保随机化过程的透明度与可信性。
盲法实施：
患者盲法： MBSR组患者未被告知自己在比较组，减小了潜在的心理预期效应。
数据采集盲法： 使用在线数据采集工具收集患者问卷，减少了研究人员的主观干预。
统计分析盲法： 统计学家不参与数据采集过程，确保数据分析的独立性。
2.5. 干预组设置与干预措施
2.5.1. 基于正念的减压疗法（MBSR）
标准化8周课程，课程结构符合正念减压授权课程指南（2017年）。
课程由经过认证的资深讲师授课，涵盖正念冥想、压力管理等内容。
2.5.2. 常规护理组（UC）
继续接受由原主治医生开具的常规医学治疗方案，研究团队不干预其治疗决策。
2.5.3. 心理生理症状缓解疗法（PSRT）
前4周： 心理教育与脱敏训练，包括疼痛机制讲解、情绪表达练习和视象运动想象训练。
后8周： 加入正念冥想，侧重于情绪管理与压力减轻，旨在巩固前4周的疗效。
2.6. 研究结局指标与评估方法
2.6.1. 主要结局指标：功能障碍改善
使用罗兰-莫里斯功能障碍问卷（RDQ）评分，量化患者的功能恢复情况。
RDQ分数范围为0-24分，数值越高表明功能障碍越严重。
2.6.2. 次要结局指标：
疼痛困扰评分： 0-10分量表，衡量过去一周的疼痛强度。
疼痛相关焦虑： 使用疼痛焦虑症状量表（PASS），评分范围为0-100分，得分越高表明焦虑水平越高。
2.6.3. 其他结局指标：
疼痛缓解： 无疼痛报告比例（评分0/10）。
功能恢复： RDQ评分为0的患者比例。
干预依从性： 课程出勤率与患者每周用于技能练习的时间。
2.7. 统计分析方法
样本量计算： 基于RDQ平均值和标准差，估算检测RDQ评分显著降低的最低样本量为每组11人，功效为80%。
数据分析：
组内比较： 配对t检验评估基线与干预后的变化。
组间比较： 使用线性混合效应模型，考虑重复测量的相关性和潜在协变量。
效应大小评估： 计算Cohen d效应量，估算组间差异的实际效应强度。
数据呈现： 连续数据以平均值±标准差或中位数呈现，分类数据以频数和百分比表示。
研究结果总结与描述扩展
参与者筛选与纳入情况： 共筛查182人，符合纳入标准的38人随机分组，35人完成了全部课程和问卷，调查完成率达到100%。
基线特征匹配： 各组间人口学与临床特征均衡，具有较强的可比性。
课程出勤率： PSRT组与MBSR组出勤率分别为76%和78%，表明患者的高依从性与干预的可行性。
该设计通过严格的标准化操作和多层次的随机化与盲法控制，确保了研究的科学性与结果的可靠性。这种全面设计为未来大型、多中心试验提供了重要的实施经验与数据基础。
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