Personalized Physical Back Training Program to Improve Physical Functioning in People with Non-specific Low Back Pain: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Logistical and operational feasibility: Data collection procedures (Questionnaire)
研究概览
简要总结
The aim of our clinical trial (2024-01285) is to determine how an individualized physical back training program affects physical functioning and back pain. The results will help identify the most effective treatments for low back pain. This feasibility study (2024-01284) aims to conduct a test run of the clinical trial. The main questions are:
- Do all procedures run smoothly?
- Does the back training program improve physical functioning?
- Does the back training program reduce back pain?
Participants will:
- Follow a back training program for 4 weeks.
- Attend group exercise sessions (30 minutes per week)
- Perform exercises at home (3x10 minutes per week).
- Fill out a daily questionnaire on pain and exercise adherence.
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
- •Individuals who
- •have access to the University Sports of the Lucerne Universities (i.e., students, employees, alumni, subscribers),
- •report NSLBP for at least 6 weeks (e.g., no upper limit of pain duration),
- •report activity limiting NSLBP (i.e., at least one activity with a PSFS Score of ≤ 5/10 on a scale from 0 = unable to perform due to NSLBP to 10 = able to perform at the same level as before NSLBP),
- •identify NSLBP as their primary musculoskeletal complaint,
- •are between 18 and 65 years of age,
- •understand the German language,
- •are willing to participate in the study (i.e., adhere to a 4-week intervention),
- •and provide written informed consent.
排除标准
- •Individuals who …
- •have been diagnosed with specific LBP (e.g., fractures, carcinoma, anomalies, nerve root affection with neurological signs such as sensitivity or reflex loss, muscle weakness, or radicular pain below the knee),
- •report red flags associated with any serious pathology or specific LBP (e.g., major trauma of the back, unintended weight loss, saddle anaesthesia, changes in bowel or bladder function associated with LBP, progressive lower extremity neurologic deficits, fever),
- •are less than 12 months post-surgery following any surgery on the lower back,
- •are on a waiting list for any surgery on the lower back,
- •are pregnant or have given birth within the last 12 months,
- •are planning to become pregnant in the next 12 months,
- •have diagnosed peripheral and/or central neurological disease,
- •have diagnosed psychological and/or psychiatric condition,
- •have diagnosed chronic toxic substances abuse (i.e., drugs, alcohol),
- •take specific medication (i.e., neuroleptics, sedatives, anti-epileptics, antidepressants),
- •are not allowed to exercise during the intervention period (e.g., on medical advice, due to a health-related condition),
- •or are expecting to be absent more than 2 weeks during the training intervention period.
结局指标
主要结局
Logistical and operational feasibility: Data collection procedures (Questionnaire)
时间窗: Baseline to 4 weeks
Qualitatively evaluate the usability of the questionnaire through interviews.
Logistical and operational feasibility: Data collection procedures (Clinical Assessment)
时间窗: Baseline to 4 weeks
Qualitatively evaluate the usability of the clinical assessment through interviews.
Logistical and operational feasibility: Resource management
时间窗: Baseline to 4 weeks
Qualitatively evaluate the time and personnel required for conducting the study through interviews.
Logistical and operational feasibility: Data collection procedures (Access)
时间窗: Baseline to 4 weeks
Qualitatively evaluate the access of study personnel to necessary documents and the database through interviews.
Logistical and operational feasibility: Acceptability and suitability of the intervention and study procedures
时间窗: Baseline to 4 weeks
Qualitatively assess the acceptability and suitability of the intervention and study procedures through interviews.
Logistical and operational feasibility: Sample characteristics
时间窗: Baseline to 4 weeks
Analyze sample characteristics (e.g., gender, age) using descriptive statistics.
Logistical and operational feasibility: Response time
时间窗: Baseline
Response time (in days).
Logistical and operational feasibility: Recruitment capability
时间窗: Baseline
Ratio of invited individuals to included participants.
次要结局
- Pain intensity (NRS)(Baseline to 4 weeks)
- Health-related quality of life (EQ-5D-5L)(Baseline to 4 weeks)
- Self-rated physical functioning (PSFS)(Baseline to 4 weeks)
- Self-rated physical functioning (RMDQ)(Baseline to 4 weeks)
- Health-related quality of life (EQ-VAS)(Baseline to 4 weeks)
- Intervention-related (serious) adverse events(During the 4 week intervention period)