Effects of the "Spinomed Active" Orthosis on Chronic Back Pain in Women With Osteoporotic Vertebral Bone Fracture and Hyperkyphosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Back pain
研究概览
简要总结
Osteoporotic vertebral fractures often lead to postural changes, chronic spinal pain conditions and limited functionality. Orthoses that straighten the spine have been shown in studies to have a positive effect on pain, posture and the functional state of patients with a fresh vertebral fracture.
The planned study investigates the effect of the orthosis "Spinomed active" in patients aged ≥ 65 years with at least one non-acute osteoporotic vertebral fracture (at least 3 months ago) and chronic back pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor were unaware of participant status (i.e. spinomed active or control) and were not allowed to ask correspondingly
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Living independently in the community
- •≥ 1 low-traumatic vertebral fracture ≥ 3 months ago
- •Chronic back pain according to the national guideline for low back pain
- •Mean back pain intensity NPS ≥ 1 (1-10 scale)
- •Hyperkyphosis, kyphosis angle according to Debrunner >40°
- •Intact skin or adequate wound coverage in the area of the contact surface of the orthosis
排除标准
- •Secondary osteoporosis (as determined by study physician)
- •Expected change in overall pain therapy during the study period
- •Structurally fixed kyphosis, lack of extension ability of the thoracic spine
- •Kyphoplasty, vertebroplasty
- •Use of back orthoses during the last 6 months
- •Depression
- •Dementia, cognitive impairment (Mini Mental Test < 25)
- •Fresh neurological deficits; incontinence > grade 1
- •Body dimensions that do not allow for adjustment of the back orthosis
- •Absence during baseline and follow-up assessments
研究组 & 干预措施
Spinomed active orthosis
Wearing the orthosis for 16 weeks
干预措施: Spinomed active (Other)
Control group
No intervention: non spinomed active control
结局指标
主要结局
Back pain
时间窗: At baseline and after 16 weeks (i.e. over 16 weeks)
Change in back pain (mean intensity over 4 weeks on the "numeric pain scale (NPS) "0-10").
次要结局
- Kyphosis angle(At baseline and after 16 weeks (i.e. over 16 weeks))
- Trunk strength/performance(At baseline and after 16 weeks (i.e. over 16 weeks))
- Functional capacity(At baseline and after 16 weeks (i.e. over 16 weeks))
- Everyday life skills(At baseline and after 16 weeks (i.e. over 16 weeks))
- Pulmonary function(At baseline and after 16 weeks (i.e. over 16 weeks))
- Balance capacity(At baseline and after 16 weeks (i.e. over 16 weeks))