Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Percentage of Screened Participants Who Are Female
研究概览
简要总结
Guidelines advocate several complementary modalities as alternatives to drugs and other invasive treatments for chronic low back pain (LBP) conditions. However, there is little high-quality research investigating treatments for back-related leg pain, one of the more severe and disabling presentations of LBP. The investigators are conducting a pilot study to assess the feasibility of a future phase II multi-site randomized clinical trial (RCT). The future trial will assess the comparative effectiveness of a novel supported biopsychosocial self-management (SBSM) intervention versus Medical Care (MC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Back-related leg pain (BRLP) consistent with the Quebec Task Force (QTF) classifications 2-4 (radiating pain into proximal or distal extremity with or without neurological signs).
- •18 years of age or older.
- •Back-related leg pain severity of 3 or higher at all screening assessments (0 to 10 scale)
- •Episode duration of 12 weeks or more
- •Ability to read English fluently
排除标准
- •Spinal stenosis (QTF 7)
- •Specific, non-mechanical causes of BRLP (QTF 11; e.g. infection, tumor)
- •Contraindications to study interventions (e.g. spinal fracture (QTF 5))
- •Inflammatory conditions of the lumbar spine (QTF 11)
- •Lumbar fusion
- •Progressive neurological deficits
- •Cauda equina syndrome
- •Pregnancy, nursing
- •Ongoing care from another healthcare provider for BRLP
- •Severe unmanaged comorbid conditions (e.g. substance abuse, major depressive disorder, stage 3 hypertension).
研究组 & 干预措施
Supported Biopsychosocial Self-Management (SBSM)
Supported Biopsychosocial Self-Management (SBSM)
干预措施: Supported Biopsychosocial Self-Management (SBSM) (Behavioral)
Medical Care
Medical Care
干预措施: Medical Care (Drug)
结局指标
主要结局
Percentage of Screened Participants Who Are Female
时间窗: 6 month period of active study screening
As a measure of recruitment feasibility, the number of female participants in the study is reported
Percentage of Enrollees in Medical Care Group Reporting Taking Medications as Prescribed
时间窗: Through study treatment, an average of 3 months
As a measure of participant treatment adherence associated with feasibility, the number of enrollees who are part of the medical care arm self-reporting taking medications as prescribed is reported.
Percentage of Provider Visits Where All Required Intervention Activities Were Delivered
时间窗: Through study treatment, an average of 3 months
As a measure of provider fidelity, the percentage of provider vists where 100% of required intervention activities were delivered is reported.
Percentage of Enrollees Attending Required Sessions
时间窗: Through study treatment, an average of 3 months
As a measure of participant treatment adherence associated with feasibility, the number of enrollees attending the minimum number of required study sessions (6 for SBSM and 2 for Medical Care) are reported.
Percentage of Enrollees in Supported Biopsychosocial Self-management Group Reporting Participation in Home Practice
时间窗: Through study treatment, an average of 3 months
As a measure of participant treatment adherence associated with feasibility, the number of enrollees who are part of the supported biopsychosocial self-management arm of the study who self-report participation in home treatment practice is reported.
Percentage of Enrollees Completing the Month 6 Assessment
时间窗: Month 6 assessment
As a measure of data collection feasibility, the number of enrollees completing the month 6 assessment is reported.
Percentage of Enrollees Not Receiving Any Treatment
时间窗: Through study treatment, an average of 3 months
As a measure of intervention acceptability and credibility associated with feasibility, the number of enrollees not receiving any treatment is reported.
Percentage of Enrollees Completing the Month 3 Assessment
时间窗: Month 3 assessment
As a measure of data collection feasibility, the number of enrollees completing the month 3 assessment is reported.
Percentage of Weekly Pain Severity and Frequency Assessments Completed
时间窗: Through completion of all weekly assessments, an average of 6 months
As a measure of data collection feasibility, the number of weekly pain severity and frequency assessments completed by participants is reported.
Percentage of Enrolled Participants Who Are From Racial or Ethnic Minority Populations
时间窗: 6 month period of active enrollment
As a measure of enrollment feasibility, the number of participants enrolled from racial or ethnic minority populations is reported.
Percentage of Enrollees Receiving Prohibited Treatments
时间窗: Through study treatment, an average of 3 months
As a measure of intervention acceptability and credibility associated with feasibility, the number of enrollees receiving prohibited treatments, (contamination), during the 12-week intervention phase of the study is reported.
Number of Particpants Screened Per Month
时间窗: 6 month period of active study screening
As a measure of recruitment feasibility, the average number of participants screened per month is reported
Percentage of Screened Participants Who Are From Racial or Ethnic Minority Populations
时间窗: 6 month period of active study screening
As a measure of recruitment feasibility, the number of participants from racial or ethnic minority populations is reported.
Number of Participants Enrolled Per Month
时间窗: 6 month period of active study screening
As a measure of enrollment feasibility, the average number of participants recruited per month is reported.
Percentage of Enrolled Participants Who Are Female
时间窗: 6 month period of active study enrollment
As a measure of enrollment feasibility, the number of female participants enrolled in the study is reported.
Percentage of Enrollees Satisfied With Treatment
时间窗: Through study treatment, an average of 3 months
As a measure of intervention acceptability and credibility associated with feasibility, treatment satisfaction was reported by participants via a 7-point Likert satisfaction scale, ranging from 1, "completely satisfied," to 7, "completely dissatisfied," where lower numbers indicate greater satisfaction. The percentage of enrollees satisfied with treatment is reported as a percent value representing those who choose "somewhat satisfied" or better on the scale.
次要结局
未报告次要终点