Movement Control Exercises With and Without Specific Breathing Techniques for the Treatment of Chronic Low Back Pain: an Open-label Feasibility Study With 2-month
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Well-Being in Pain Questionnaire
研究概览
简要总结
Chronic low back pain (CLBP) is a leading disability globally. Exercise therapies are one of the most commonly prescribed treatment options for CLBP. Specific breathing techniques have been shown to enhance brain-based pain modulation and autonomic nervous system balance; these changes have been shown to improve clinical effectiveness in terms of pain management and psychological factors compared to general exercise. However, no previous studies have added a specific breathing technique protocol to an evidence-based exercise program for CLBP.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-68-years-old
- •Low back pain lasting more than 3 months (pain sensation more than 3 days per week)
- •A numerical pain scale of more than 3
- •≥ 2/6 positive low back movement control tests (as described by Luomajoki et al.)
- •Roland-Morris Disability Questionnaire score of five or greater
- •Who are physically able to perform movement control tests and provide written informed consent.
排除标准
- •Any history of malignant cancer
- •Neurological disease affecting the central nervous system (MS, dementia)
- •Rheumatic disease (fibromyalgia, ankylosing spondylitis/rheumatoid arthritis)
- •Chronic obstructive pulmonary disease,
- •Spinal surgery in the last 12 months
- •A cardiac pacemaker
- •Signs and symptoms of nerve root pathology during the clinic visits.
- •Women who become pregnant during the data collection will also be excluded from the study.
结局指标
主要结局
Well-Being in Pain Questionnaire
时间窗: Change from Baseline Well-Being in Pain Questionnaire at 2 months
Self-developed questionnaire to screen the effects of pain on a person's biopsychosocial well-being. Scale from 0 (no subjective well-being in pain) to 60 (maximum subjective well-being in pain)
The numerical pain rating scale (NRPS)
时间窗: Change from Baseline The numerical pain rating scale at 2 months
Eleven-point numerical pain scale. Scale from 0 (no pain) to 10 (worst imaginable)
The Tampa Scale of Kinesiophobia (TSK)
时间窗: Change from Baseline The Tampa scale of Kinesiophobia at two months
Assessment of subjective kinesiophobia (fear of movement). Scale from 17 (the minimal kinesophobia) to 68 (the most maximum kinesiophobia).
The Roland Morris Disability Questionnaire (RMDQ)
时间窗: Change from Baseline The Roland Morris Disability Questionnaire at 2 months
Questionnaire measuring disability in chronic low back pain populations. Scale from 0 (no disability) to 24 (maximum low back pain related disability)
The Pain and Sleep Questionnaire Three-Item Index (PSQ-3)
时间窗: Change from Baseline The Pain and Sleep Questionnaire Three-Item Index at two months
Effect of pain on sleep. Scale from 0 (pain have no any effect on sleep) to 30 (pain have maximum effect on sleep)
The Pain Catastrophizing Scale (PCS)
时间窗: Change from Baseline he Pain Catastrophizing Scale at two months
Assessment of catastrophizing (tendency to magnify the threat value of a pain stimulus) related to pain. Scale from 0 (no catastrophizing thoughts) to 52 (maximum catastrophizing thoughts)
Central Sensitization Inventory (CSI)
时间窗: Change from Baseline Central Sensitization Inventory at two months
Screening of central sensitization phenomenon. Scale from 0 (no central sensitization) to 100 (worst imaginable central sensitization)
The 5-level EQ-5D version of the EuroQol
时间窗: Change from Baseline The 5-level EQ-5D version of the EuroQol at 2 months
Health status. Scale from 0 (dead) to 1 (full health)
The Generalised Anxiety Disorder Assessment (GAD-7)
时间窗: Change from Baseline The Generalised Anxiety Disorder Assessment at two months
Measure of generalised anxiety disorder related symptoms. Scale from 0 (the most minimal anxiety) to 21 (the most severe anxiety)
The Pain Self-Efficacy Questionnaire (PSEQ)
时间窗: Change from Baseline The Pain and Sleep Questionnaire Three-Item Index at two months
assess the self-efficacy of people in pain have in daily activities. The scale is from 0 points (not at all confident) to 6 points (completely confident).
次要结局
- Quantifying(Through study completion, an average of 2 months)
- Feasibility of intervention protocol, recruitment and enrollment(Through study completion, an average of 2 mothns)
- Responsiveness(Through study completion, an average of 2 months)
研究者
Jani Mikkonen
Principal Investigator / PhD student at Institute of Clinical Medicine
Kuopio University Hospital