Prognostic Factors of a Favorable Outcome Following a Supervised Exercise Program for Soldiers With Sub-acute and Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Change from baseline in the degree of disability in persons with Low back pain at 6 weeks
研究概览
简要总结
Low back pain (LBP) encompasses heterogeneous patients unlikely to respond to a unique treatment. Identifying sub-groups of low back pain may help to improve treatment outcomes. Our objective was to identify variables associated with a favorable outcome in soldiers with sub-acute and chronic LBP participating in a multi-station full-body supervised exercise program. The results obtained may permit generation of potential treatment effect modifiers that will eventually have to be validated before being recommended for clinical practice.
详细描述
All participants took part in the 6-week exercise program, as well as in the two evaluation sessions (pre- and post- exercise program). At the initial evaluation, subjects completed forms and questionnaires on sociodemographics, symptomatology, comorbidities, work restrictions, pain and functional limitations and fear-avoidance beliefs. A physiotherapist measured their lumbar and hip mobility, conducted diagnostic and pain provocation tests and assessed endurance of the trunk muscles. Following the initial evaluation, subjects took part in the 6-week multi-station full-body supervised exercise program (2 to 3 sessions per week). The Oswestry disability questionnaire (ODI) was completed at the initial and at the final evaluations. The change in ODI score following the program was considered the principal measure reflecting favorable or unfavorable outcome.
An improvement of 50% in the initial ODI score was considered the reference standard to determine a favorable outcome. Univariate associations with favorable outcome were tested using chi-square or paired t-tests. Variables that showed between-group (favorable/unfavorable) differences were entered into a logistic regression after determining the sampling adequacy. Finally, continuous variables were dichotomized and the sensitivity, specificity and positive and negative likelihood ratios were determined for the model and for each variable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •episode of subacute or chronic LBP with or without radiation to the lower limbs
- •minimal score of 17% on the Modified Oswestry Disability Index
排除标准
- •previous surgery to the spinal column,
- •lumber spine injection in the past two weeks
- •signs of upper motor neuron lesions
- •serious medical conditions (e.g. tumor, fracture, rheumatoid arthritis, osteoporosis)
- •unavailability to participate in the 6-week exercise program
研究组 & 干预措施
Intervention group
Standardized six-week duration multi-station full-body supervised exercise program. The frequency was 2-3 sessions per week. The duration of each session was 60 minutes.
干预措施: Multi-station full-body supervised exercise program (Other)
结局指标
主要结局
Change from baseline in the degree of disability in persons with Low back pain at 6 weeks
时间窗: Baseline and 6 weeks after the start of the exercises program
The Modified Oswestry Disability Index is a self-administered questionnaire (10 questions with numerical scale 0-5) whose purpose is to evaluate the severity of the limitations and restrictions suffered by patients with LBP
次要结局
- Length of employment in the army(Baseline)
- Number of treatments received before initial evaluation in the study(Baseline)
- Referred pain in lower limbs(Baseline)
- Work restrictions(Baseline)
- Sensation of tingling or numbness(Baseline)
- Use of antidepressant(Baseline)
- Lumbar and Hip Mobility(Baseline)
- Screening or diagnostic tests of lumbar instability(Baseline)
- Endurance of the extensor muscles of the trunk(Baseline)
- Weight of participants(Baseline)
- Body mass index(Baseline)
- Time since last onset of low back pain(Baseline)
- Height of participants(Baseline)
- Fear-Avoidance Beliefs Questionnaire(Baseline)
- History of Low Back pain(Baseline)
- Use of anti-inflammatory drugs(Baseline)
- Pain in sitting position(Baseline)
- Pain in lying position(Baseline)
- Pain in standing position(Baseline)
- Pain during walking(Baseline)
- Pain when coughing or sneezing(Baseline)
- Mean pain perceived in the last 48 hours(Baseline)
- Worst pain perceived in the last 48 hours(Baseline)
- Endurance of the anterior abdominal muscles of the trunk(Baseline)
- Endurance of the lateral muscles of the trunk(Baseline)
研究者
Marc Perron
Professor of clinic
Laval University