Training Therapy for the Secondary and Tertiary Prevention of Backache and Low Back Pain: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Pain Frequency
研究概览
简要总结
Work place related (lower) back pain in medical personnel is limiting to workability.
Even though occupational prevention programs are increasingly established, data on the effectiveness of training interventions offered at work-sites is largely missing.
In this randomized, investigator-blind, controlled feasibility study we aim to compare the effectiveness of device assisted training therapy in comparison to a general recommendation "to stay active" or group gymnastics in terms of pain frequency and intensity (main outcome). Additional outcome variables are: quality of life, psychological well-being, work efficiency, of sick-leave days.
Eligible employees (2 x 30) of the General Hospital of Vienna (AKH) over the age of 45 years suffering from (lower) back pain (>30 days/last year) of intensity ≥ 3 (numeric scale 0-10) will be included in two parallel groups. Group I starts with a device (DAVID) assisted training (40 training sessions; 2x / week) of the core trunk musculature. Group II gets instructions and an advice on how to "stay active" during the first 6 months. Assessment will be conducted before and after these 6 months; then groups are switched, thus, study subjects act as their own controls.
详细描述
Work place related pain syndromes of the (lower) back pose a major health problem for medical personnel. Beside the discomfort and limitations of the affected patients, a severe restriction of their ability to work must be considered.
For secondary prevention of back pain, health promotion programs are recommended. These consist of psychosocial and ergonomic interventions and, above all, a regular strengthening of the stabilizing muscle groups. Specific strength and endurance training for the trunk musculature with appropriate equipment is considered as a useful preventive measure and thus commonly offered at large corporations, even during working hours of the staff. However, data clearly demonstrating the effectivity and cost-effectiveness of these interventions is largely missing.
This pilot study serves several purposes:
On one hand, the feasibility of a randomized, controlled study is to be examined, which is to prove the effectiveness of the medical training therapy in comparison to a general recommendation "to stay active" or in comparison to group gymnastics. In particular, logistical problems in the organization of training therapy and training compliance must be clarified.
On the other hand, this pilot study serves to generate hypotheses. Several variables in regard to possible changes due to the training intervention will be investigated. Collected pilot data will be used for corresponding case number estimates of a subsequent confirmatory study. The outcome variables are: number of back pain days and intensity, quality of life, psychological well-being, work efficiency, days of sick-leave.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects must have suffered from (low) back pain for at least 6 days in the last month, without treatment by a doctor or feeling in need of treatment.
- •subject reported pain should reach the level of 3 or more on the numeric rating scale of 0-10 (0 equals no pain and 10 represents the strongest imaginable pain) [Larsen et al, 2008; Blagsted et al., 2008].
- •protocol documenting pain and work disability/limitations daily for a month must be completed
- •written consent after completed patient education by a physician must be given
排除标准
- •(one or more of the following)
- •in order to rule out generalized musculoskeletal disorders, subjects should report discomfort or pain in no more than 3 different body parts
- •arterial hypertension and cardiovascular events such as myocardial infarction within the last year and / or cardiomyopathy NYHA III and IV.
- •symptomatic, lumbar disc herniation with associated neurological deficits
- •specific spinal diseases as potential underlying reason for a back pain syndrome including rheumatoid arthritis, ankylosing spondylitis, manifested osteoporosis with St.p. vertebral fractures, tumors.
- •St.p. traumatic damage of spine, pelvis or femur in the last 6 months
- •insufficiently healed surgical wounds in any body area
- •imminent musculoskeletal, spinal, hip or knee surgery
- •chronic infectious diseases
- •diagnosed mental illness
- •previous severe trauma with permanent Musculoskeletal dysfunction
- •pregnancy prior to study entrance examination
- •no written consent to the study
- •less than 1 year before retirement or planned job change within one year
结局指标
主要结局
Pain Frequency
时间窗: 6 months
Incidence of pain-days and pain-intensity
次要结局
- Sick-Leave(6 months)
研究者
Prof. Dr. Gerold Ebenbichler
Principal Investigator
Medical University of Vienna