Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain (SUPPORT trial)
针对背部相关腿痛的综合支持性生物心理社会自我管理(SUPPORT 试验)
基本信息
- 批准号:10317103
- 负责人:
- 金额:$ 34.93万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2020
- 资助国家:美国
- 起止时间:2020-12-15 至 2023-11-30
- 项目状态:已结题
- 来源:
- 关键词:AchievementAddressAdherenceAdvocateAreaBackBack PainBehaviorBehavioralBreathingCaringChiropractorChronicChronic disabling painChronic low back painClinical TrialsCognitiveCompetenceComplexDataData CollectionEffectivenessEnrollmentExerciseFoundationsFutureGuided imageryGuidelinesHealthHealth PersonnelHomeHuman ResourcesIndividualInterventionLightLow Back PainMedicalMind-Body InterventionMinorityMinority EnrollmentModalityMuscle relaxation phaseNational Center for Complementary and Integrative HealthOpioidOutcome MeasurePainPain DisorderPain ResearchPain in lower limbPain managementParticipantPatientsPersonal CommunicationPersonal SatisfactionPersonsPharmaceutical PreparationsPhasePilot ProjectsPlayProblem SolvingProceduresProtocols documentationProviderPsychological FactorsQuality of lifeRandomized Clinical TrialsRelaxationResearchRiskRoleSecureSelf CareSelf ManagementSeveritiesSiteSpecific qualifier valueSpinal ManipulationSurveysSymptomsTrainingUnited StatesWomanbasebiopsychosocialcare deliverychronic painchronic painful conditioncomparative effectivenesscomparison interventioncostdisabilityeffective therapyevidence basefollow-upinnovationnon-drugnovelpain patientpain reductionpain self-managementphysical therapistprovider interventionpsychosocialrandomized trialrecruitresponsesocial factorssymptom managementtrial comparing
项目摘要
PROJECT SUMMARY
Low back pain (LBP) disorders are the most common and disabling chronic pain conditions worldwide. Nearly
1/3 of LBP patients develop back-related leg pain (BRLP), which is associated with greater pain severity and
poorer quality of life. Chronic BRLP is complex, influenced by interrelated physical, psychological, and social
factors. Most cases are not optimally managed, as demonstrated by persistent disability, and use of unimodal
treatments, including opioids, which have limited scientific backing, are risky, and fail to meet patient
biopsychosocial needs. While guidelines advocate several complementary modalities for chronic LBP, there is
little high-quality research on treatments for BRLP, especially ones that promote healthy pain management
behaviors. Physical therapists (PTs) and chiropractors (DCs) are the most common front-line providers of
conservative LBP treatment in the US, and are well-suited to play a larger role in supporting patient self-care
for the prevalent, burdensome, and costly BRLP conditions.
The long-term objective of this research is to shift the current paradigm for BRLP away from unimodal,
symptom-based care, to an individualized, whole person, behavioral targeted approach. In response to current
evidence gaps, we propose a pilot study (R34) to assess the feasibility of a future phase II multi-site randomized
clinical trial (RCT). Informed by our previous and ongoing LBP research, the Integrated SUPPORTed
Biopsychosocial Self-Management for Back Related Leg Pain trial will assess the comparative effectiveness of
a novel supported biopsychosocial self-management (SBSM) intervention delivered by PTs and DCs, versus
Medical Care (MC). The R34 pilot study aims are:
AIM 1: to conduct a Planning Phase to develop protocols, train personnel, and secure regulatory
approvals. Special emphasis will be placed on providing competency-based training to PTs and DCs in the
SBSM intervention focused on whole person care delivery, integrating psychosocial and physically oriented
strategies specifically for chronic BRLP.
AIM 2: To assess the feasibility of recruitment and enrollment (recruitment/enrollment rates, participant
views on participation), delivering experimental and comparison interventions (acceptability and adherence,
provider fidelity, participant and provider views), and data collection (follow-up rates).
This research addresses NCCIH high priorities areas of integrated mind body approaches for
symptom management of chronic BRLP, a costly, disabling, and understudied condition. The pilot study will
establish the essential foundation for the SUPPORT trial, the first RCT comparing an innovative SBSM
intervention to medical care for BRLP. In doing so, we anticipate DCs and PTs will play a more impactful role
guiding BRLP patients’ healthy pain self-management behaviors, resulting in less disability and greater overall
health and wellbeing.
项目概要
腰痛 (LBP) 疾病是全世界最常见且致残的慢性疼痛疾病。几乎
1/3 的 LBP 患者会出现背部相关的腿部疼痛 (BRLP),这与疼痛的严重程度和疼痛程度有关
生活质量较差。慢性 BRLP 很复杂,受到相互关联的身体、心理和社会的影响
因素。大多数病例没有得到最佳管理,如持续的残疾和使用单峰治疗所证明的那样
包括阿片类药物在内的治疗方法的科学依据有限,存在风险,并且无法满足患者的需要
生物心理社会需求。虽然指南提倡多种治疗慢性腰痛的补充方法,但
关于 BRLP 治疗的高质量研究很少,尤其是促进健康疼痛管理的研究
行为。物理治疗师 (PT) 和脊椎按摩师 (DC) 是最常见的一线治疗提供者
在美国,保守的 LBP 治疗非常适合在支持患者自我护理方面发挥更大的作用
针对普遍存在、繁重且昂贵的 BRLP 条件。
这项研究的长期目标是改变当前 BRLP 范式的单峰模式,
基于症状的护理,采取个性化、全面、有针对性的行为方法。响应当前
证据差距,我们提出一项试点研究(R34)来评估未来 II 期多中心随机试验的可行性
临床试验(RCT)。根据我们之前和正在进行的 LBP 研究,综合支持
背部相关腿痛生物心理社会自我管理试验将评估以下方法的比较有效性
由 PT 和 DC 提供的新型支持性生物心理社会自我管理 (SBSM) 干预措施,与
医疗保健(MC)。 R34 试点研究的目标是:
目标 1:进行规划阶段以制定协议、培训人员和确保监管
批准。将特别强调向区域内的 PT 和 DC 提供基于能力的培训
SBSM 干预侧重于提供全人护理,整合心理社会和身体导向
专门针对慢性 BRLP 的策略。
目标 2:评估招募和入学的可行性(招募/入学率、参与者
对参与的看法),提供实验和比较干预措施(可接受性和依从性,
提供者保真度、参与者和提供者观点)以及数据收集(跟进率)。
这项研究涉及 NCCIH 综合身心方法的高度优先领域
慢性 BRLP 的症状管理是一种昂贵、致残且研究不足的疾病。该试点研究将
为 SUPPORT 试验奠定重要基础,这是第一个比较创新 SBSM 的随机对照试验
BRLP 的医疗干预。在此过程中,我们预计 DC 和 PT 将发挥更有影响力的作用
指导 BRLP 患者健康的疼痛自我管理行为,从而减少残疾并提高整体水平
健康和福祉。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Gert Bronfort其他文献
Gert Bronfort的其他文献
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{{ truncateString('Gert Bronfort', 18)}}的其他基金
Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain (SUPPORT trial)
针对背部相关腿痛的综合支持性生物心理社会自我管理(SUPPORT 试验)
- 批准号:
10365290 - 财政年份:2021
- 资助金额:
$ 34.93万 - 项目类别:
Spinal Manipulation and Patient Self-Management to Prevent Back Pain Chronicity
脊柱手法和患者自我管理可预防慢性背痛
- 批准号:
10463642 - 财政年份:2017
- 资助金额:
$ 34.93万 - 项目类别:
Clinical Coordinating Center for Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain (PACBACK)
预防急性至慢性背痛的脊柱手法和患者自我管理临床协调中心 (PACBACK)
- 批准号:
9308477 - 财政年份:2017
- 资助金额:
$ 34.93万 - 项目类别:
Spinal Manipulation and Patient Self-Management to Prevent Back Pain Chronicity
脊柱手法和患者自我管理可预防慢性背痛
- 批准号:
10226259 - 财政年份:2017
- 资助金额:
$ 34.93万 - 项目类别:
Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain (PACBACK) Study
脊柱手法和患者自我管理预防急性至慢性背痛 (PACBACK) 研究
- 批准号:
10893117 - 财政年份:2017
- 资助金额:
$ 34.93万 - 项目类别:
Spinal Manipulation and Patient Self-Management to Prevent Back Pain Chronicity
脊柱手法和患者自我管理可预防慢性背痛
- 批准号:
9923972 - 财政年份:2017
- 资助金额:
$ 34.93万 - 项目类别:
Dose-Response of Manipulation for Cervicogenic Headache
颈源性头痛手法治疗的剂量反应
- 批准号:
8311664 - 财政年份:2011
- 资助金额:
$ 34.93万 - 项目类别:
Dose-Response of Manipulation for Cervicogenic Headache
颈源性头痛手法治疗的剂量反应
- 批准号:
8687601 - 财政年份:2011
- 资助金额:
$ 34.93万 - 项目类别:
Dose-Response of Manipulation for Cervicogenic Headache
颈源性头痛手法治疗的剂量反应
- 批准号:
8496496 - 财政年份:2011
- 资助金额:
$ 34.93万 - 项目类别:
Dose-Response of Manipulation for Cervicogenic Headache
颈源性头痛手法治疗的剂量反应
- 批准号:
8024435 - 财政年份:2011
- 资助金额:
$ 34.93万 - 项目类别:
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