The Added Value of a Behavioral Weight Reduction Program to Blended Rehabilitation in Patients With Chronic Low Back Pain: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Brief Pain inventory (BPI)
研究概览
简要总结
We will recruit overweight/ obese participants between the age of 18 and 65 with chronic nonspecific low back pain . The participants will be randomly assigned to one of two interventions (each lasting 10 weeks). All interventions will be delivered in a blended format and will be a combination of online education material and face-to-face sessions with a physical therapist. The first group (experimental intervention) will receive a behavioral weight reduction program combined with pain neuroscience education plus cognition-targeted exercise therapy. Participants in the second group (control intervention) will receive pain neuroscience education and cognition-targeted exercise therapy alone. Allocation to the groups will be at random. Participants and assessors will be blinded for group allocation. The primary outcomes is pain intensity. Secondary outcomes include other pain related outcomes, body composition, physical activity, sedentary behavior, dietary intake and function.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overweight (BMI ≥ 25 kg/m2) or obese (BMI ≥ 30 kg/m2) with chronic low back pain
- •Non-specific low back pain for at least 3 months' duration
- •Currently seeking care for low back pain
- •Native Dutch speaker
- •Access to internet and computer/tablet/smartphone
排除标准
- •Leg pain of 7 or higher (on a maximum of 10) on a numeric rating scale
- •Evidence of specific spinal pathology (e.g., hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture or malignancy)
- •Evidence of a severe underlying comorbidity (e.g. diabetes, cardiovascular problems, metabolic diseases)
- •BMI ≥ 40 kg/m2
- •Being pregnant or given birth in the preceding year
- •Currently receiving dietary or exercise interventions
研究组 & 干预措施
Experimental intervention
10 weeks blended therapy delivered using a blended approach. The blended (online and on site) therapy consists of instructive video's, challenges to complete, 1-on-1 sessions with the therapist, online quizzes, online booklets, and online diaries/workbooks. . The experimental group will receive a behavioral weight reduction program combined with pain neuroscience education plus cognition-targeted exercise therapy. The combined therapy will adhere to guidelines for patient-centered care
干预措施: Pain Neuroscience Education (Behavioral)
Experimental intervention
10 weeks blended therapy delivered using a blended approach. The blended (online and on site) therapy consists of instructive video's, challenges to complete, 1-on-1 sessions with the therapist, online quizzes, online booklets, and online diaries/workbooks. . The experimental group will receive a behavioral weight reduction program combined with pain neuroscience education plus cognition-targeted exercise therapy. The combined therapy will adhere to guidelines for patient-centered care
干预措施: Cognition-targeted exercise therapy (Behavioral)
Experimental intervention
10 weeks blended therapy delivered using a blended approach. The blended (online and on site) therapy consists of instructive video's, challenges to complete, 1-on-1 sessions with the therapist, online quizzes, online booklets, and online diaries/workbooks. . The experimental group will receive a behavioral weight reduction program combined with pain neuroscience education plus cognition-targeted exercise therapy. The combined therapy will adhere to guidelines for patient-centered care
干预措施: Behavioral weight reduction program (Behavioral)
Control intervention
Identically to the experimental intervention, the therapy is provided in a blended format within 10 weeks. Also identical to the experimental intervention, the control intervention will adhere to guidelines for patient-centered care. The control group will receive pain neuroscience education in combination with cognition-targeted exercise therapy alone.
干预措施: Pain Neuroscience Education (Behavioral)
Control intervention
Identically to the experimental intervention, the therapy is provided in a blended format within 10 weeks. Also identical to the experimental intervention, the control intervention will adhere to guidelines for patient-centered care. The control group will receive pain neuroscience education in combination with cognition-targeted exercise therapy alone.
干预措施: Cognition-targeted exercise therapy (Behavioral)
结局指标
主要结局
Brief Pain inventory (BPI)
时间窗: Difference between groups at 6 months (T3) after therapy completion
Questionnaire for assessing clinical pain
次要结局
- Brief Pain inventory (BPI)(T3-assessment 6 months after therapy completion)
- Central sensitization inventory (CSI)(T3-assessment 6 months after therapy completion)
- TANITA Bio-electrical Impedance Analyzer(T3-assessment 6 months after therapy completion)
- SECA wall-fixed SECA wall-fixed stadiometer(T3-assessment 6 months after therapy completion)
- TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat(T3-assessment 6 months after therapy completion)
- TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass(T3-assessment 6 months after therapy completion)
- TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status(T3-assessment 6 months after therapy completion)
- Food Frequency Questionnaire(T3-assessment 6 months after therapy completion)
- International Physical Activity Questionnaire (IPAQ)(T3-assessment 6 months after therapy completion)
- Sedentary Behavior Questionnaire of Busschaert et a(T3-assessment 6 months after therapy completion)
- The Short Form Health Survey-36 items (SF-36)(T3-assessment 6 months after therapy completion)
- Fear avoidance Beliefs Questionnaire(T3-assessment 6 months after therapy completion)
研究者
Malfliet Anneleen
Prof. Dr. Anneleen Malfiet
Vrije Universiteit Brussel