Spinal Manipulative Therapy Treatment Effect Modifiers in Individuals With Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- numeric pain rating scale
研究概览
简要总结
This study considers whether treatment effects in response to spinal manipulative therapy for individuals experiencing low back pain are dependent upon the context in which the intervention is provided. Half of the participants will receive spinal manipulative therapy with encouragement to interact with the provider and information to enhance expectations for the effectiveness of the intervention. The other half will receive spinal manipulative therapy with minimal interaction with the provider.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently experiencing low back pain defined as pain located below the 12th rib and above the inferior gluteal fold with or without corresponding leg pain;
- •Low back pain symptom intensity rated as 4/10 or higher during the last 24 hour;
- •Appropriate for conservative treatment for low back pain.
排除标准
- •Non-English speaking;
- •Systemic medical conditions know to affect sensation (e.g. diabetes);
- •History of lumbar surgery or fracture within the past 6 months;
- •Received spinal manipulative therapy for treatment of low back pain within past 6 months;
- •Current or history of chronic pain condition other than low back pain
研究组 & 干预措施
augmented spinal manipulative therapy
Participants in this group will receive spinal manipulative therapy provided by a practitioner interacting in a warm and friendly way who is free to respond to participant conversation. Participants in this group will receive information about the effectiveness of spinal manipulative therapy for some individuals experiencing low back pain.
干预措施: spinal manipulative therapy (Procedure)
neutral spinal manipulative therapy
Participants in this group will receive spinal manipulative therapy provided by a practitioner engaging in minimal interaction. Participants in this group will not receive information about the effectiveness of spinal manipulative therapy for some individuals experiencing low back pain.
干预措施: spinal manipulative therapy (Procedure)
结局指标
主要结局
numeric pain rating scale
时间窗: Change in baseline at 2 weeks
0 to 100 with 0= no pain at all to 100= worst pain imaginable
次要结局
- North American Spine Society Lumbar Spine Outcome Assessment(2 weeks)
- Oswestry Disability Index(Change in baseline at 2 weeks)
- Back Performance Scale(Change in baseline immediately following spinal manipulative therapy during day 1 and at 2 weeks)
- Patient Centered Outcome Questionnaire(change in baseline immediately following spinal manipulative therapy during day 1)
- Quantitative Sensory Testing(change in baseline immediately following spinal manipulative therapy during day 1)
- Working alliance subscale of the Pain Rehabilitation Expectation Scale(change in baseline immediately following spinal manipulative therapy during day 1)
- Semi- structured qualitative interview seeking insight into answers on the working alliance subscale of the pain rehabilitation expectation scale(2 weeks)