Identification and Treatment of Back Pain in Elderly Women With Osteoporosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 4
- 主要终点
- Back pain
研究概览
简要总结
Background: Back pain and osteoporosis with vertebral fractures are common conditions in elderly women and significantly affect their quality of life. A common complication of osteoporosis are vertebral fractures. Treatment with bone-specific drugs does often not help the pain condition caused by the vertebral fractures even when the progress of the disease has decreased. Vertebral fractures often result in deformation of the spine and poorer quality of life of the individual. The spinal kyphosis also affects the lung function and the effect of the kyphosis itself is severe. Alternative treatments of back pain may lead to reduced drug demand for pain. Physical activity is one of the most important factors that regulates bone mass and can also affect balance and fall risk positively. The back orthosis that we intend to use in the treatment study has been shown in some previous scientific studies to strengthen the muscles in the back and also decrease the pain.
Purpose: The purpose of the study was to evaluate the effect of treatment of back pain in elderly women with an activating functional orthosis versus treatment with a group of physiotherapeutic tools and a control group for a six-month treatment period and follow-up after 12 months from the start of study. The aim was also to study elderly women with osteoporosis and back pain in a follow-up study of a cohort of women at high risk of osteoporotic fractures, with focus on back pain, functional capacity and quality of life.
The aim was to study the effect of treatment with activating functional orthosis versus physiotherapeutic treatment in a group and a control group without treatment. The main outcomes will be the experienced perceived back pain and back extensor strength. Additional outcomes will be quality of life, balance, lung function and kyphosis. Biochemical markers for pain will be measured in the RCT (Randomized Controlled Trial).
Significance: Evaluation of alternative treatment methods such as exercise by a physiotherapist and treatment with a functional orthosis will give new additional treatment options for our patients. An activating functional orthosis could reduce the use of analgesics and increase the quality of life of the affected women.
详细描述
The aims: 1. Identification in a population-based cohort of elderly women the occurrence of vertebral fractures, back pain and their impact on quality of life.
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To study the effect of treatment with a functional activating orthotic and physiotherapy in an equipment training group, both in comparison with a control group, on the perceived pain, back extensor muscle strength, quality of life, balance and incidence of falls, lung function and kyphosis.
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Qualitative study of how participants experienced treatment and exercise in an activating orthotic. The investigators hypothesis was that a functional orthotic could be a complementary treatment method that could reduce the use of analgesics and increase the quality of life.
The purpose of the study was to evaluate the effect of treatment of back pain in elderly women with an activating spinal orthotic versus treatment with a physiotherapy equipment training group and a control group for a six-month treatment period and a follow-up six months after the end of treatment. The aim was also to identify the occurrence of vertebral fractures in a cohort of elderly women and to investigate their perceived quality of life.
Background: Osteoporosis is a condition in the skeleton that is characterized by reduced bone density and an increased risk of fractures [1]. Back pain and osteoporosis with vertebral fractures are common conditions in elderly women that significantly affect their quality of life. Vertebral fractures are the most common type of osteoporotic fracture [2]. Vertebral fractures are underdiagnosed and are a major problem. It is estimated that only one third of vertebral fractures are clinically detected [3]. The lifetime risk for a Swedish postmenopausal woman to get a clinically detected vertebral fracture is approximately 15% [4].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Spinal orthosis group
Women wearing the spinal orthosis Spinomed for 6 months at least 2 hours a day.
干预措施: Spinal orthosis Spinomed (Device)
Equipment training group
Women training once a week in an equipment training group led by a physiotherapist for six months.
干预措施: Equipment training (Other)
Control
Women in the control group get no intervention for six months.
结局指标
主要结局
Back pain
时间窗: Baseline and six months
Measured with Visual Analogue Scale
次要结局
- Substance P(Baseline and six months)
- IL-6 Interleukin(Baseline and six months)
- Back muscle extensor strength(Baseline and six months)
- Kyphosis(Baseline and six months)
- Paindrawing(Baseline and six months)
- Falls(Baseline and six months)
- Balance(Baseline and six months)
- SF-36(Baseline and six months)
- Hand grip strength(Baseline and six months)
- Height(Baseline and six months)
- Log book(Baseline and six months)
- Gait speed(Baseline and six months)
- Borg CR-10(Baseline and six months)
- CGRP Calcitonin Gene Related Peptide(Baseline and six months)
- QUALEFFO-41(Baseline and six months)
- Lung function(Baseline and six months)
- EQ-5D(Baseline and six months)
研究者
Helena Salminen
PI
Karolinska Institutet