The Adult Degenerative Scoliosis Exercise Trial (Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
Adult degenerative scoliosis is the most common spine deformity in adults. Patients present a lateral curvature of the spine and vertebra rotation. Curves meeting indications for treatment affect 24% of the aging adult population. Adult scoliosis causes pain, curve progression, and cosmetic deformity affecting quality of life and function. Pain affects 90% of patients with AS. Other than surgery for severe cases and pain medication, very little non-operative treatments have been investigated. Scoliosis-specific exercises have shown promise in a single study in adults and in an Alberta adolescent study.
The goal of this pilot randomized controlled trial on the effect of Schroth exercises in adults with degenerative scoliosis compared to observation is to determine the feasibility of conducting a larger study. This study will help plan and secure funding for a larger study by examining the ability to recruit enough eligible participants, whether patients can follow the prescribed program session attendance and complete the home exercises prescribed. The early estimate the effects of the exercises on pain, quality of life, disability, deformity and posture measurements will help determine the potential of this approach and the likely success of a larger RCT. This study addresses a need of adults with degenerative scoliosis who do not meet surgical indications but still experience pain and disability by exploring a promising exercise approach.
详细描述
1.1 Adult degenerative scoliosis. Scoliosis is a 3D spine deformity including frontal curves, vertebral rotations, and sagittal changes.1 A curve >10o after 18 years of age is called Adult Scoliosis (AS) and is the most common adult spinal deformity.2 Degenerative AS arises from asymmetric disc and facet degeneration or due to leg length discrepancy, hip pathology, and osteoporosis.3 Most AS curves are lumbar or thoracolumbar.4 The prevalence of degenerative AS is higher than adolescent scoliosis, but estimates range widely at 2.4% - 68%56. The prevalence of curves >20° is 24%.7
AS causes pain, curve progression, radiculopathy, or cosmetic deformity affecting quality of life and physical function8-10. Pain affects 90% of patients with AS9. Adults with degenerative scoliosis present more pain than with idiopathic scoliosis.3 Severe radiculopathy (47%), claudication (9%), weakness (8%), myelopathy, and bowel/bladder dysfunction(1%) are also more common in adults with scoliosis.11 Sagittal imbalance in AS is strongly correlated with disability and low quality of life.12 Curve progression is common in AS at 2-6o/yr.13 It is thus relevant to offer treatments to prevent curve progression and the signs and symptoms above.
1.2 What treatment is available? There is an important lack of evidence about non-operative treatments for AS despite the recommendation of non-operative treatments are the first line for treating AS.8,14,15 This suggestion arise mostly because of the high complications rates with surgery and poor bone quality8. However, exercise has generally not been offered in studies comparing non-operative to operative care.8,14,15 The main goal of rehabilitation in AS is to decrease pain, improve function and slow disease progression to avoid surgery.16,17 Our review on exercises for AS18 found only one study with high risk of bias showing that 20 weeks of scoliosis specific exercises compared to general physiotherapy led to significantly more improved pain (by 3.2/10 pts), SRS-22 quality of life (by 0.7/5 for function, 0.9 pain, 0.5 self-image, 0.7 mental health and 1.0 for satisfaction with care), and Oswestry disability (by 12%). Only adults with idiopathic scoliosis were included in this study19 and exercises have not yet been tested in adults with degenerative scoliosis.
1.3 Rationale for Schroth treatment: Our award winning work with adolescent idiopathic scoliosis suggests that pain, self-image and back muscle endurance improvements, as well as, reduced curve progression result from short exercise programs.20-22 Schroth is a 3D autocorrection exercise aiming to correct posture.23 Schroth exercises are not yet routinely used for adults in Edmonton, but surgeons and patients have expressed interest for evidence on exercise. Patients routinely seek treatment options for smaller curvatures and inquire about less invasive treatments than surgery.
1.4 Schroth treatment: Posture corrections are achieved with the use of pressure, mirror and therapist verbal and tactile feedback.24,25 Schroth exercises aim to improve the ability to maintain correct posture through endurance and strength training.22 Schroth exercises include de-rotation, side shifting, and stretching to establish vertebral alignment, torsion respiratory exercises, and strengthening for postural muscles.26
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
- Single (Outcomes Assessor)
盲法说明
Baseline exams will occur before randomization. Participants and therapists will be reminded not to discuss their group allocation. Evaluators will be blinded to group allocation. The statistician will also complete analyses blinded to which group received therapy or when they did.
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over 50 years old with degenerative scoliosis (n=20) with pain (>2/10). Other inclusion criteria are: (1) curves 15°-45°.
排除标准
- •Curves over 50° are surgical candidates, and will be excluded. Patients who have had cortisone or anesthetic injections within the last 3 months, surgery or presenting contra-indications to exercises (fractures, cancer, severe cardio-vascular co-morbidities, or osteopenia) will be excluded.
研究组 & 干预措施
Schroth exercise group
Will attend 5 1-hr long individual sessions to learn Schroth exercises and the home program. A 30-min. daily home program of 3 to 4 exercises will be progressed by the certified Schroth therapist using an algorithm. Patients will attend weekly 1-hr long group therapist-led exercise classes for 3 months. At each group class, adequate exercise performance will be assessed using the checklist. An algorithm guides the prescription of exercises intensity and progression from static to dynamic depending on the participant's ability. Prescription begins with Sitting on a Ball. If performed adequately, a more challenging exercise is attempted. The 3 most challenging exercises performed adequately as per the checklist will be prescribed with a detailed handout.
干预措施: Schroth exercises (Other)
Control group
Observation without treatment or with previously prescribed pain medication is the current standard for adults with degenerative scoliosis not planning surgery.
结局指标
主要结局
Recruitment rate
时间窗: 1 year
Percent of patients enrolled out of all patients invited.
次要结局
- Eligibility rate(1 year)
- Drop out rate(1 year)
- Compliance(1 year)
- Adherence(1 year)
