Immediate Effect Of Standing Trunk Extension Postures On Spinal Height And Clinical Outcome Measures In Low Back Pain: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Spinal Height (Stadiometry)
研究概览
简要总结
Background: Standing trunk extension postures have been used for many years as a mechanical approach to low back pain (LBP), sometimes directed by therapeutic intervention, sometimes subconsciously performed by patientsto relieve LBP. However, no study to date has investigated the effect of standing trunk extension postures on spinal height and clinical outcome measures.
Objective: The purpose of this study will be to evaluate in subjects with LBP following a period of trunk loading, how spinal height and/or pain, symptoms' centralization, and function outcome measures respond to:(1) standing repetitive trunk extension posture; and (2) standing sustained trunk extension posture. Lumbar range of motion (ROM) achieved during these two trunk extension postures will be compared to spinal height and outcome measures.
Methods:A pre-test, post-test comparison group design (randomized clinical trial) will be used to determine how spinal height changes in response to sustained and repetitive standing trunk extension after a period of spinal loading. The study will evaluate the effects of sustained and repetitive trunk extension in standing on spinal height, pain, symptoms' centralization and function.
Statistical Analysis: A mixed ANOVA will be used to statistically identify significant interactions and main effects for spinal height, pain and functionoutcome measures. Post-hoc pairwise comparisons will be used to locate significant differences between the different conditions. Significance will be set at α = 0.05. The Kruskal-Wallis 1-factor ANOVA for difference scores will used to determine changes of intensity and location of symptoms following sustained versus repetitive standing trunk extension. Spearman Rank correlation will be used to evaluate the relationship between spinal height changes and changes of pain and location of symptoms for each group.
详细描述
Standing trunk extension postures have been used for many years as a mechanical approach to low back pain (LBP), sometimes directed by therapeutic intervention, sometimes subconsciously performed by patients to relieve LBP. However, no study to date has investigated the effects of standing extension postures on spinal height, pain, centralization and function. Therefore, the purposes of this study will be to evaluate in a sample of LBP patients the effect of standing trunk extension, both sustained and repetitive, following a period of spinal loading, on (1) spinal height; (2) pain; (3) symptoms centralization and (4) functional measures.
Research Design(s) A pre-test, post-test comparison group design (randomized clinical trial) will be used to determine how spinal height changes in response to sustained and repetitive standing trunk extension after a period of spinal loading. The study will use a 2 (between subjects - type of trunk extension: sustained vs. repetitive) x 3 (within subjects - time: before vs. after vs. 2 weeks after) mixed design to evaluate the effects of sustained and repetitive trunk extension in standing on spinal height, pain, centralization and function outcome measures.
Subjects / Specimens Systematic consecutive sampling of up to 100 subjects with LBP (40 subjects completing both days of data collection) attending "Sports medicine and Physical therapy clinic" in Fredericksburg (Texas) as patients or for the purpose of health and wellness will be recruited. Flyers will also be posted at physician offices and the general Fredericksburg community and surrounding areas to inform subjects about the study.
Testing Sequence Subjects will be asked to attend two physical therapy sessions over approximately a 60-minute period each to complete the study.
SESSION 1
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The primary investigator will be blinded to the measurements of spinal height using stadiometry, and to the group assignment of each participant (sustained versus repetitive extension postures)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability and willingness to come twice to the clinic for approximately 60 minutes each
- •Subjects with LBP and directional preference in back extension
- •Age 18-80
- •Ability to stand for 5 minutes
- •Ability to sit for 10 minutes
- •Low back pain on Numerical Pain Rating scale (NPRS) of at least 2/10 and less or equal to 9/10
排除标准
- •Pregnancy by subject report
- •history of back surgery or spinal fractures within the last six months
- •history of spinal fusion or physician's diagnosis of spinal instability
- •current history of acute systemic infection, active inflammatory disease, or malignancy
- •subjects engaged in legal/compensation claims for their back symptoms
结局指标
主要结局
Spinal Height (Stadiometry)
时间窗: 2-week following initial visit
Spinal height of subjects measured in stadiometer (mm) from 100 to 2000 mm. Height will be compared to height at initial measure. Greater height than at initial measure will indicate height gain.
次要结局
- Modified Oswestry low back pain questionnaire(2-week following initial visit)
- Lumbar Extension range of motion (Inclinometer)(2-week following initial visit)
- Pain (Numerical pain rating scale - NPRS)(2-week following initial visit)
- Centralization (Dallas Pain Diagram)(2-week following initial visit)