Integral Movement Therapy Versus Local Movement Therapy Approach in Patients With Idiopathic Chronic Low Back Pain: a Randomized Controlled Trail.
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- CHANGE IN INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (IPAQ) SCORE
研究概览
简要总结
Systematic reviews evaluating the effectiveness of supervised exercise therapies commonly conclude that, to date, there is no evidence to support the superiority of one form of exercise over another. Randomized controlled trials to date included mostly trunk strengthening exercises (e.g. bird dog, plank) and there is no evidence about supervised, individually graded integral movement therapy program for patients with chronic low back pain (CLBP).
The research design is a randomized clinical trial with parallel-group design including two intervention groups: integral movement therapy and conventional local movement therapy. Participants in each group will receive 20 supervised sessions in a 10 week period, two times per week, with approximately 1 hour per session. Outcome assessments will occur at baseline and immediately post-intervention, follow up will take place at 6 months and 12 months after finishing the intervention. Pre specified analyses will evaluate the main effects of the treatment.
This trial will use a novel, previously unexplored integral approach to CLBP through exercises. In contrast to commonly used exercise programs, the integral program does not include specific local strength exercises for hip and trunk flexors and extensors. However, learning dynamic trunk muscle control in various body positions with added limb movements could be beneficial because of the parallels to everyday work. The study will contribute to clinical practice by providing evidence to guide professionals when deciding for the proper and efficient treatment of patients with CLBP.
详细描述
Literature suggests several different methods for coping with CLBP. Supervised exercise therapies are among the most commonly advocated treatments for nonspecific CLBP. However, findings from a systematic reviews concluded the most effective model of exercise therapy remain uncertain. Although several supervised randomized controlled trails, focusing on different approaches for managing the CLBP using movement therapy have been published so far, there is no evidence about integral movement therapy program for patients with CLBP. Systematic reviews evaluating the effectiveness of supervised exercise therapies commonly conclude that, to date, there is no evidence to support the superiority of one form of exercise over another. Randomized controlled trials to date include mostly trunk strengthening exercises (e.g. bird dog, plank).
The Primary study aim is to evaluate the efficiency of supervised and individually graded integral movement therapy program in patients with CLBP on pain, quality of life and functional abilities. Further, the secondary aim is to compare the difference in outcome measures to supervised, conventional local movement therapy. The following research questions are addressed:
(I) Does the supervised and individually graded integral movement therapy program have an effect on reducing pain, improving the quality of life and functional abilities in patients with chronic idiopathic low back pain? (II) Does the supervised and individually graded integral movement therapy program have a clinically more significant effect on reducing pain, improving the quality of life and functional abilities compared to the supervised, conventional local movement therapy? (III) Which program has a better effect on specific core stability strength (e.g., maximal isometric trunk flexion, extension and lateral flexion) and proprioception?
We intend to allocate 80 adults, aged between 30 and 60 years old, into two groups. Repeated measurements will be performed at the baseline and post therapy. Follow-up measures will take place 6 months and one year after the last therapy and include an International Physical Activity Questionnaire (IPAQ), qualitative and quantitative assessment of pain with the Oswestry disability index questionnaire (ODI) and the Numerical rating scale (NRS)
Eligibility Inclusion criteria
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
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic idiopathic low back pain which persists at least 12 weeks or two acute low back pain episodes in the last 12 months.
- •Patients aged between 30 and 60 years.
- •Capable of at least low physical activity to be able to complete movement therapy program.
排除标准
- •Severe spinal stenosis, spondylolisthesis, fibromyalgia.
- •Lumbar spine surgery.
- •Vascular disease.
- •Neurological deficits because of nerve root or spinal cord compression.
- •Ongoing treatment for low back pain.
- •Pregnancy.
- •Comorbid health conditions that could prevent active participation in exercise.
研究组 & 干预措施
Local Movement Therapy
Group receiving treatment in form of Local Movement Therapy Program.
干预措施: Local Movement Therapy (Other)
Integral Movement Therapy
Group receiving treatment in form of Integral Movement Therapy Program.
干预措施: Integral Movement Therapy (Other)
结局指标
主要结局
CHANGE IN INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (IPAQ) SCORE
时间窗: 1 week before the first therapy, after 11 weeks, at 6-month follow up and at 12-month follow up.
The International Physical Activity Questionnaire (IPAQ) is developed to measure health-related physical activity (PA) in populations.
Change in Oswestry Low Back Disability Questionnaire (ODI) Score
时间窗: 1 week before the first therapy, after 11 weeks, at 6-month follow up and at 12-month follow up.
Oswestry Low Back Disability Questionnaire is used to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools.
Change inn Numeric Rating Scale for Pain (NRS) Score
时间窗: 1 week before the first therapy, after 11 weeks, at 6-month follow up and at 12-month follow up.
The NRS for pain is a unidimensional measure of pain intensity in adults.
次要结局
- Change in Sit-to-stand test score(1 week before the first therapy and after 11 weeks of therapy.)
- Change in Chair sit-and-reach test score(1 week before the first therapy and after 11 weeks of therapy.)
- Change in Spine flexibility.(1 week before the first therapy and after 11 weeks of therapy.)
- Change in Timed-up-and-go test (TUG) score(1 week before the first therapy and after 11 weeks of therapy.)
- Change in 6 minute walk test score(1 week before the first therapy and after 11 weeks of therapy.)
- Change in trunk reposition error test score(1 week before the first therapy and after 11 weeks of therapy.)
- Change in Spinal extensor endurance(1 week before the first therapy and after 11 weeks of therapy.)
- Change in Sharpened Romberg test score(1 week before the first therapy and after 11 weeks of therapy.)
- Change in Trunk Muscle Strength(1 week before the first therapy and after 11 weeks of therapy.)
- Change in maximal pelvic inclination(1 week before the first therapy and after 11 weeks of therapy.)
研究者
Nejc Sarabon
Assoc. Prof. Dr. Sc.
University of Primorska