Body Structure and Capacity Evaluation of Adults With Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Socliosis Research Society 22-revised total score
研究概览
简要总结
Adults with scoliosis have not been the focus of much research in physical therapy despite their prevalence being very important. Adults with idiopathic scoliosis have a reported prevalence of about 2-11%. This includes adolescents with idiopathic scoliosis who have become adults but still have a scoliosis. They do not get much treatment as the adolescent treatment focuses on preventing worsening of the curvatures and the risk of progression is significantly reduced once a person reaches skeletal maturity. Still some patients experience self-image, function and pain issues which may be amenable to treatment using specific exercises as was recently shown. With ageing population a growing number of adults with de novo degenerative scoliosis is observed. This is a spinal misalignment due to spine degeneration. Adult degenerative scoliosis with pain is thought to affect about 24% of the ageing adults. This population has not been investigated very much.
Before planning conservative treatments for adults with scoliosis it would be important to describe what deficit these adults present that may be targeted by physical therapy. The objective of this study is to compare samples of patients with adults degenerative scoliosis, adult idiopathic scoliosis to matched healthy controls (for age, height and weight). Participants will complete questionnaires and a physical exam to identify which limitations they present that may be amenable to treatment with physical therapy. This information will assist planning trials to address the needs of these two neglected patient populations.
详细描述
Study design: A cross sectional study will be undertaken.
Participants will complete 45 minutes of questionnaires online using REDCAP then complete a physical exam for 1h15 including assessment of the posture, flexibility of the spine and lower extremity, neurological function, response to pain provocation test of the spine, pelvis and hips and tests of pulmonary function.
Sample size: A 0.8 point difference is expected between the expected score in the healthy groups (of 4.5) and the score in the scoliosis groups (expected scores of 3.7) on the SRS 22 with an expected SD of 1 in each group. With alpha=0.0167 (corrected for multiple comparisons) and beta=0.8 using an unilateral test needed 27 patients per group for a paired t test analysis.
Assessment methodology: Participants will bring their last X-ray and will fill out a survey and have a physical exam.
-Analysis : The population will be described with averages and standard deviations for the continuous data and frequencies with confidence intervals for the categorical.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for the idiopathic scoliosis group :
- •Diagnosis of idiopathic scoliosis
- •Age ⩾18 years old
- •Curve severity over 10°
- •Fluent in English.
- •Inclusion criteria for the degenerative scoliosis group :
- •Diagnosis of degenerative (De novo) scoliosis
- •Age ⩾45 years old
- •Curve severity over 10°
- •Fluent in English.
排除标准
- •for the scoliosis groups :
- •History of spine surgery or
- •History of diseases affecting the torso or lower extremity function
- •Surgery or trauma
- •Secondary scoliosis
- •Unable to fill out the questionnaires or attend the physical examination,
- •Pregnant or gave birth between 0 and 2 years ago.
- •Inclusion criteria for healthy groups:
- •Age ⩾ 18 years
- •Matched for age/height/weight (+/-5 years; +/- 10 lbs; +/- 10cm) to a scoliosis participant
- •Fluent in English
- •Exclusion criteria for healthy groups:
- •Serious systemic pathology
- •Spine deformity
- •Spine surgery
- •Pregnant or gave birth between 0 and 2 years ago
- •Unable to fill out the questionnaires or attend the physical examination
- •Received treatments for the spine/the lower limbs within the last year
结局指标
主要结局
Socliosis Research Society 22-revised total score
时间窗: baseline
The SRS-22r is a quality of life questionnaire which consists of 22 questions assessing 5 quality of life domains: Function, Pain, Self-Image, Mental health (5 questions), satisfaction (2 questions). Each category is rated on 5. The categories are summed and divided by 5 to have a total score on 5 points. 5 is the best score and 1 the worst
次要结局
- Perceived ability to work(baseline)
- Fear avoidance related to work and physical activity(baseline)
- Range of motion (lumbar, thoracic, lower limbs)(baseline)
- Prevalence of patient in each specific LBP categories(baseline)
- Pain intensity: Numerical rating scale(baseline)
- Function(baseline)
- Sensory capacity(baseline)
- Flexibility(baseline)
- Response to the Mechanical Diagnosis and Therapy (McKenzie) exam(baseline)
- Perceived appearance(baseline)
- LBP prognosis score(baseline)
- Physical activity level(baseline)
- Posture(baseline)
- Voluntary motor capacity(baseline)
- Spirometric respiratory capacity(baseline)
- Range of motion (Hip abduction, thoracic rotation)(baseline)
- Range of motion (lumbar rotation)(baseline)
- Nerves tension tests(baseline)
- Involuntary motor capacity(baseline)
- Prevalence of patients per potential treatment(baseline)