A COgNitive FuncTional Therapy+ Pathway Versus an Interdisciplinary Pain Management Pathway for Patients With Severe Chronic Low Back Pain (CONFeTTI Trial): a Randomized Controlled Trial of a Combined Physical/Psychological Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- Pain-related disability during the last 7 days
研究概览
简要总结
This study is a patient-blinded 2-arm randomized controlled trial (RCT) assessing the effectiveness (in the short and long term) as well as total healthcare costs of a CFT+ (a combined physiotherapist/psychologist intervention) pathway compared with interdisciplinary pain management pathway (usual care) for patients with chronic low back pain referred to interdisciplinary pain treatment.
The primary aim of this pragmatic randomized controlled trial (RCT) is to investigate if a physiotherapy-led CFT pathway that includes psychologist support (CFT+) with the option of additional usual care (if needed) is superior to the currently recommended interdisciplinary pain management pathway (usual care) in reducing disability at 12 months in patients with severe cLBP. In addition, an economic evaluation will investigate total health care costs of the two pathways at 12 months.
In addition the study will explore changes in pain intensity, quality of life, thoughts and beliefs about back pain, and analgesic consumption in patients randomized to the CFT+ pathway compared with patients randomized to the interdisciplinary pain management pathway.
详细描述
Evidence suggests that chronic low back pain (LBP) is a multidimensional biopsychosocial problem including various contributing factors, such as negative pain cognitions, pain-related fear and emotional distress, avoidant and protective movement behaviors,and unhelpful lifestyle factors such as activity avoidance and sleep problems. Current guidelines recommend that patients with chronic LBP who do not benefit from primary care treatment should be referred to interdisciplinary pain rehabilitation in secondary care settings. However, such treatments are often expensive, not easily accessible, and have only modest effects.
Cognitive Functional Therapy (CFT) is a newer physiotherapeutic treatment approach for patients with chronic low back pain, involving all important elements for the individual patient. Physical factors are handled via change in pain-provoking movement patterns. Psychological factors are handled in relation to fear, avoidance behaviour, catastrophization, stress, anxiety, depression and negative thoughts. Lifestyle factors are addressed in relation to physical inactivity and sleep problems. The approach is individualized and provides the patient with opportunities for action in relation to his or her own situation via information, reflection, change of movement and training of functions and physical level.
CFT has been shown to reduce fear and worry in patients with chronic low back pain compared to other interventions, and the effect of CFT alone on patients with severe chronic low back pain has been recently investigated in an observational pilot study (without randomization) in our Pain Center (publication attached in link). In this study, we found a good and clinically relevant effect of CFT compared to standard treatment in a University Hospital Interdisciplinary Pain Center. In the pilot study, we noted that there were barriers to optimal treatment engagement for some patients (e.g. lack of motivation), and that several patients with high levels of psychological distress had limited benefits. Inclusion of early psychologist support to assist in promoting behavioral change and directly target deeper behavioral strategies could potentially improve patient adherence to the CFT intervention.
This fully-powered randomized controlled study compares effectiveness of this physiotherapeutic intervention including psychologist support (CFT+) pathway with effectiveness of interdisciplinary pain treatment (recommended care) pathway in patients with severe chronic low back pain.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This study has ethical approval that the patients involved are not aware that there is a difference between the two treatment strategies in the study. Patient masking in this study is done to ensure that included patients are as representative as possible.
The randomization sequence is distributed and stored in sealed opaque envelopes handled only by an independent study secretary who has no other involvement in the trial. All outcome measurements are completed via an electronic questionnaire system sent via personal links to the patients' official digital inbox, e-Boks (used by public hospitals, municipalities and other institutions to send official documents to citizens of Denmark). The researcher responsible for the statistical analyzes are blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-75 years referred to interdisciplinary pain management at the Pain Center
- •Adequate Danish language skills
- •• Chronic low back pain (pain in the area between the 12th rib and buttock crease lasting more than 6 months)
- •Low back pain self-reported as significant contributor to daily disability (Yes/No)
- •Low back pain intensity > 4 on 0-10 numerical rating scale
- •Provide consent that data collected via questionnaires and registries can be used for research purposes
排除标准
- •Previously attended an interdisciplinary pain management program
- •Wheel chair bound
- •Suicidal ideation - evaluated using Patient Health Questionnaire-9 (Item 9 has to be answered "never")
- •Self-reported former/ present addictive drug or alcohol behavior
- •Self-reported current pregnancy
结局指标
主要结局
Pain-related disability during the last 7 days
时间窗: Change from baseline to 12 months
Proportion of patients who have an improvement of 8 points or more on the Oswestry Disability Index (ODI) at 12 months. The ODI assesses pain-related disability within the last 7 days, asking patients to reflect on their ability to manage their everyday life despite their back pain for these domains: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and travelling. Each domain is scored on a 0-5 scale. The index is calculated by dividing the summed score by the total possible score multiplied by 100 and expressed as a percentage with 100 representing the greatest disability.
次要结局
- Analgesics(Assessed at 0, 3 and 12 months)
- Average pain intensity during the last 24 hours(Assessed at 0, 3, 6, 9, and 12 months)
- Health-related quality of life(Assessed at 0, 3 and 12 months)
- The Patient Global Impression of Change(Assessed at 3, 6, 9 and 12 months)
- Level of pain catastrophization(Assessed at 0, 3 and 12 months)
- Level of patient enablement(Assessed at 0, 3 and 12 months)
- Economical evaluation(Assessed at 12 months)
- Trajectory of Pain-related disability during the last 7 days(Assessed after 0, 3, 6, 9, and 12 months)
- Adverse reactions(Assessed at 3, 6, 9 and 12 months)
研究者
Henrik Bjarke Vægter
Professor in Physiotherapy
Odense University Hospital