Determining the Effectiveness of the Pain and Disability Drivers Management Model on the Management of Low Back Pain - a Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Number of participants recruited for the study
研究概览
简要总结
This study aims to assess the feasibility of procedures for conducting a pragmatic cluster nonrandomized controlled trial and to collect data on the effectiveness of a previously validated approach that takes into account all the pain and disability drivers associated with low back pain - the Pain and Disability Drivers Management Model (PDDM).
The overall objective is to provide data to assess the feasibility of implementing a multisite pragmatic cluster nonrandomized clinical trial to determine the effectiveness of the PDDM on short-term patient-related outcomes compared to the most recent clinical practice guidelines to improve the management of patients living with low back pain.
详细描述
Rationale: Low back pain (LBP) is highly prevalent, recurrent and is the leading cause of disability among all MSK disorders (1). Evidence endorses the use of clinical practice guidelines (CPGs) to help clinicians establish the diagnosis and guide treatments. Yet, they have shown limitations as they mostly focus on addressing biological deficits and poorly integrate psychosocial factors. Thus, we recently developed and validated the Low Back Pain and Disability Drivers Management (PDDM) model that aims to identify the domains influencing pain and disability to create a personalized clinical profile facilitating diagnosis, prognostic and treatment options (2).
Aims and hypotheses: 1) To assess the feasibility of procedures for conducting a pragmatic cluster nonrandomized controlled trial and 2) to explore preliminary evidence of the effectiveness of the PDDM model compared to CPGs on short-term patient-related outcomes. We hypothesize that the feasibility of conducting such trial will be confirmed. Our secondary hypothesis is that the PDDM model will lead to better short-term patients' outcomes compared to CPGs.
Methods:
Design: A pilot cluster nonrandomized controlled trial where allocation occurs at the level of the clinics (CONSORT). Physiotherapy clinics from different demographic and administrative settings will be recruited.
Participants: We aim to recruit a minimum of 12 physiotherapists (PT) per group arm with each PT recruiting a minimum of 5 patients within a 9-month timeframe. To be included, PTs will have to 1) be working with LBP patients, 2) be able to participate in a 1-day training workshop and 3) assess and initiate treatment of their patients guided by the PDDM model (intervention group) or CPGs (comparator). Patients 18 years or older presenting with a primary complaint of LBP without serious underlying pathology will be included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participating patients will be blinded to their therapist's allocation. Outcomes assessor will be blinded to the participants' allocation since data will be coded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinicians' eligibility criteria:
- •Inclusion Criteria:
- •be working with patients presenting with LBP
- •be able to participate in a one-day training workshop
- •assess and initiate treatment of their LBP patients based on the PDDM model (intervention) or the most recent CPGs (control)
- •be fluent in French
排除标准
- •For the control group, clinicians will be excluded if they have already attended a workshop on the PDDM model
- •Patients' eligibility criteria:
- •Inclusion Criteria:
- •be 18 years or older
- •presenting with a primary complaint of LBP
- •be able to understand and read French
- •have access to an email address
- •be willing to provide patient-related outcomes measures
- •Exclusion Criteria:
- •Patients not deemed fit for rehabilitation by their therapist (i.e., red flags)
- •Patients already undergoing physiotherapy treatment for their episode of LBP
研究组 & 干预措施
The Low Back Pain and Disability Drivers Management model
Participating clinicians in the intervention arm will use the PDDM model to guide assessment and treatment of their patients and data will be collected over a 12-weeks period.
干预措施: The Low Back Pain and Disability Drivers Management model (Other)
Low back pain clinical practice guidelines
Participating clinicians in the active comparator arm will perform assessment and treatment of their patients based on the recommendations from the most recent and high-quality clinical practice guidelines (CPGs) and data will be collected over a 12-weeks period.
干预措施: Low back pain clinical practice guidelines (Other)
结局指标
主要结局
Number of participants recruited for the study
时间窗: up to nine months.
Overall recruitment of participants during the nine months recruitment period. Recruitment rate defined as % of eligible clinicians who enrolled in the study for each clinic. Clinician/patient recruitment ratio.
Retention rate of participants
时间窗: T2 (12 weeks post enrollment for patients and through study completion, up to nine months for clinicians)
Measured by attrition rate of the participants : % of patients enrolled in the study but who did not complete the study (e.g., questionnaires, dropped out, lost to follow-up)
Suitability of admissibility criteria
时间窗: T2 (through study completion, up to nine months)
Determined based on overall recruitment rate and clinicians' answers to two questions at the end of the study (T2): are the criteria sufficient or too restrictive? Is it obvious who meets and who does not meet the eligibility criteria
Clinicians' compliance to study protocol/fidelity of intervention
时间窗: T2 (through study completion, approximately nine months)
Assessment of clinician's compliance to the study protocol will include (yes/no): 1) completion of the knowledge and skills assessment following the workshop, and 2) the reporting of five patients' clinical data by the PT according to the PDDM model or CPGs following their initial assessment at baseline (T0).
次要结局
- Change from baseline in nervous system dysfunctions at 12 weeks(Change in CSI-9 scores at 0, 6 and 12 weeks.)
- Change from baseline in severity and impact of pain on function at 12 weeks(Change in BPI scores at 0, 6 and 12 weeks.)
- Change from baseline in cognitive-affective drivers of pain and disability at 12 weeks(Change in SBST scores at 0, 6 and 12 weeks.)
- Change from baseline in contextual drivers of pain and disability at 12 weeks(Change in FABQ-W scores at 0, 6 and 12 weeks.)
- Change from baseline in nervous system dysfunctions at 12 weeks(Change in PAINdetect scores at 0, 6 and 12 weeks.)
- Change from baseline in cognitive-affective drivers of pain and disability at 12 weeks(Change in FABQ-physical activity scores at 0, 6 and 12 weeks.)
- Change from baseline in cognitive-affective drivers of pain and disability at 12 weeks(Change in CPSS scores at 0, 6 and 12 weeks.)