Personalized Physical Back Training Program to Improve Physical Functioning in People With Non-specific Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Self-rated physical functioning
研究概览
简要总结
Personalized medicine and individualized therapeutic approaches are prominent in current research. But are these approaches also effective for treating non-specific low back pain (NSLBP)? NSLBP is one of the most common musculoskeletal issues, which can impair physical well-being, reduce the quality of life, and limit physical functioning. Additionally, it contributes to substantial direct and indirect healthcare costs, such as frequent doctor visits and work absences. Despite NSLBP being a significant burden for both individuals and society, effective alleviation methods remain unclear. The investigators' research project therefore aims to investigate whether personalized therapy, specifically a personalized physical back training program, can effectively address NSLBP. Within the context of NSLBP, the investigators' specific aim is to improve physical functioning as this outcome is considered relevant from all perspectives, including those of patients, clinical professionals, researchers, and guidelines.
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
- Quadruple (Participant, Care Provider, 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
- •Access to the University Sports of the Lucerne Universities (i.e., students, employees, alumni, subscribers)
- •NSLBP for at least 6 weeks
- •Activity limiting NSLBP (at least one activity with a PSFS Score of ≤ 50/100 on a scale from 0 = unable to perform due to NSLBP to 100 = able to perform at the same level as before NSLBP)
- •Age between 18 and 65 years
- •Understand the German language
- •Willing to participate in the study
- •Written informed consent
排除标准
- •Specific LBP
- •Red flags associated with any serious pathology or specific LBP,
- •Being on a waiting list for or less than 12 months post any surgery of the lower back
- •Pregnancy or given birth within the last 12 months
- •Diagnosed central neurological disease
- •Not allowed to exercise
- •Participant in the feasibility study
- •Expecting to be absent for more than 2 weeks during the intervention period
研究组 & 干预措施
Personalized back exercises
The study intervention is a 12-week personalized physical back training program. It consists of six to eight exercises selected from a predefined set by a physical therapist or medical doctor. These exercises are selected through a clinical reasoning process, i.e., they are tailored and problem-oriented, based on the results of a clinical assessment.
干预措施: Personalized back exercises (Other)
Non-personalized back exercises
The active control intervention is a 12-week non-personalized physical back training program. It consists of six to eight exercises selected from a predefined set by a physical therapist or medical doctor. These exercises are not selected through a clinical reasoning process, i.e., they are neither tailored nor problem-oriented nor based on the results of a clinical assessment.
干预措施: Non-personalized back exercises (Other)
结局指标
主要结局
Self-rated physical functioning
时间窗: Baseline to 12 weeks
Change in Patient-Specific Functional Scale (PSFS), most bothersome activity. Range from 0 (unable to perform due to NSLBP) to 100 (able to perform at the same level as before NSLBP)
次要结局
- Self-rated physical functioning(Baseline to 4, 8, and 24 weeks)
- Self-rated physical functioning (RMDQ)(Baseline to 4, 8, 12, and 24 weeks)
- Health-related quality of life (EQ-VAS)(Baseline to 4, 8, 12, and 24 weeks)
- Health-related quality of life (EQ-5D-5L)(Baseline to 4, 8, 12, and 24 weeks)
- Pain intensity (NRS)(Baseline to 4, 8, 12, and 24 weeks)
- Safety outcome(During the 12 week intervention period)
研究者
Claudio Perret
Prof. Dr. Claudio Perret
Universität Luzern