Myofascial Trigger Point Release and Paced Breathing Training for Chronic Low Back Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Post-intervention pain severity
研究概览
简要总结
A study to explore whether two different treatment approaches, myofascial trigger point release and core stabilization exercises, both with and without additional paced breathing training, can help patients with chronic low back pain (CLBP) and whether one of the two treatments is superior.
详细描述
This is a randomized controlled trial to evaluate the effect of myofascial trigger point release therapy compared to core stabilization exercises, both with and without additional paced breathing training, on patients with chronic low back pain (CLBP). The main focus is on changes in pain severity, anxiety and depression, heart rate variability, and use of analgesic medication. Outcomes are measured at baseline (pre-intervention), after ten treatments (post-intervention), at three- and at six-month follow-up.
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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Age between 20 and 70 years
- •LBP at least once a week during the last three months
- •Pain intensity rated at least 4 on an 11-point scale (0=no pain, 10=worst pain imaginable)
- •Muscular pain during flexion, extension and lateral flexion
排除标准
- •Acute hernia
- •Acute local or generalized inflammation
- •Neurological disorders such as multiple sclerosis, Parkinson's disease, hemiplegia
- •Fibromyalgia
- •Radicular symptoms (Lasègue's sign, weakness of foot dorsiflexion muscle, needles or tingling in the legs)
- •Paraspinal tumors or metastases
- •Cancer under chemo- or radio-surgical treatment or requiring such during the next 12 months
- •Leg prostheses
- •Rheumatic, cardiovascular or chronic pulmonary condition precluding 45-minute physical therapy (contraindication declared by a physician)
- •Severe depression or severe anxiety currently requiring psychotherapy and/or pharmacotherapy
- •Suicidal tendencies
- •Drug abuse or addiction
- •Pregnancy existing or planned during the study period
研究组 & 干预措施
Core stabilization exercises
Patients with CLBP who practice core stabilization exercises
干预措施: Core stabilization exercises (Other)
Core stabilization exercises and paced breathing training
Patients with CLBP who practice core stabilization exercises combined with paced breathing training
干预措施: Core stabilization exercises and paced breathing training (Other)
Myofascial trigger point release
Patients with CLBP who receive myofascial trigger point release therapy
干预措施: Myofascial trigger point release (Other)
Myofascial trigger point release and paced breathing training
Patients with CLBP who receive myofascial trigger point release therapy combined with paced breathing training
干预措施: Myofascial trigger point release and paced breathing training (Other)
结局指标
主要结局
Post-intervention pain severity
时间窗: 5 weeks
Self-reported severity of LBP after ten treatments with the assigned intervention, assessed with the 4-item pain severity score of the Brief Pain Inventory (BPI). The items are rated on an 11-point scale (0=no pain, 10=worst pain imaginable), the score is reported as the mean of the corresponding items.
次要结局
- HRV analysis: Change in RMSSD(24-hour ECG measurements taken at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up)
- Pain severity at three-month follow-up(Measured at three-month follow-up)
- Pain severity at six-month follow-up(Measured at six-month follow-up)
- Change in patients' belief in therapists' expertise(Measured at baseline (pre-intervention) and 5 weeks (post-intervention))
- Change in the use of analgesic medication(Assessed at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up)
- Change in anxiety(Measured at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up)
- Change in therapists' expectation of improvement(Measured at baseline (pre-intervention) and 5 weeks (post-intervention))
- HRV analysis: Change in LF/HF ratio(24-hour ECG measurements taken at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up)
- Change in patients' expectation of improvement(Measured at baseline (pre-intervention) and 5 weeks (post-intervention))
- HRV analysis: Change in SDNN(24-hour ECG measurements taken at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up)
- Change in pain interference(Measured at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up)
- Change in depression(Measured at baseline (pre-intervention), 5 weeks (post-intervention), three- and six-month follow-up)