Effects of Spinal Stabilization Exercises on Dynamic Balance and Functional Performance in Adults With Subacute and Chronic 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
- 40
- 试验地点
- 1
- 主要终点
- Change on dynamic balance
研究概览
简要总结
The investigators would like to know which one of two exercise programs will have a greater effect on balance, functional performance, daily function, and pain on individuals with low back pain (LBP) after 2, 4 and 8 weeks.
Specifically, the differences in dynamic balance, functional performance, pain intensity, and disability level will be compared between participants who receive spinal stabilization exercises program (SSE) and those who receive a general exercise program (GE) which includes range-of-motion (ROM) and flexibility exercises.
The research hypotheses are:
- The SSE program will significantly improve dynamic balance and functional performance in adult participants with sub-acute and chronic LBP at two and four weeks as well as after an eight-week follow-up after initiating intervention.
- The SSE program will significantly improve pain intensity and disability level in adult participants with sub-acute and chronic LBP at two and four weeks as well as after an eight-week follow-up after initiating intervention.
- In adult participants with sub-acute and chronic LBP, the group receiving the SSE program will demonstrate significantly improved dynamic balance, functional performance, pain intensity and disability levels compared to the placebo group receiving the GE program at two and four weeks as well as after an eight-week follow-up after initiating intervention.
详细描述
Participants will be required to wear a pair of shorts, a loose T-shirt, and a pair of tennis shoes for this study. On the first visit, the investigators will do some tests to make sure that potential participant has good feeling and strength in his/her legs. Next, each participant will fill out a few forms asking about daily function and back pain. Then, the investigators will ask the participant to perform a balance test and seven functional tests. Two investigators will be there to give these tests.
During the balance test, each participant will stand on one leg and reach out for a distance with the other leg. During the functional tests, the participant will perform 7 different tasks, including a deep squat, hurdle step, in-line lunge, shoulder mobility, active straight leg raise, rotary stability and trunk stability push-up. The investigators will demonstrate these tests before the participant perform them.
After the balance and functional tests, each participant will be randomly assigned to one of the exercise programs. One of the investigators will instruct each participant to do the appropriate exercises depending on his/her ability and pain level.
After the first visit, participants will be asked to come back 1-2 times per week for 4 weeks so the investigators can update participants' exercise program and make sure that participants do each exercise in the correct form. Each follow-up visit will take about 30 minutes. In addition to the physical therapy visits, the investigators will ask participants to do the most updated exercises at home once a day and at least 5 times a week. The investigators will give each participant an exercise log to track the frequency of the home exercise sessions. At the end of the 4 weeks, participants will come to the last physical therapy session and will be asked to continue to do the updated exercises at home once a day and at least 5 times a week for another 4 weeks until the 8-week follow-up visit.
At the 2-week, 4-week and 8-week follow-up visit, the investigators will repeat the balance and the 7 functional tests.
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 (Participant, Care Provider, Outcomes Assessor)
盲法说明
The primary investigator (PI) of this study, the outcomes assessor, will be blinded to participants' group assignment and will perform the eligibility screening and standard physical therapy examination for all participants. In addition, the PI will perform the pre- and post-intervention measurements of dynamic balance using the Y- balance test, functional performance using Functional Movement Screen, pain scores using the Numeric Pain Rating Scale, and disability levels using the Modified Oswestry Low Back Pain Disability Questionnaire.
Investigator #2, the care provider, will be blinded to the outcomes measurements and will be responsible for group allocation and administering the intervention, either a spinal stabilization exercises program or a general exercises program, to participants in both groups.
Participants will be randomly assigned to one of the two study groups and will be blinded to the other group exercise program.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals between the age of 18 to 65 years
- •Individuals who have low back pain (LBP) for 6 weeks or more
- •ability to understand, speak, and follow verbal instructions in English
- •the average pain level of at least 2 out of 10 in the past week
排除标准
- •serious spinal conditions such as fracture, infection, or tumor
- •signs of nerve root compression
- •a history of lower extremity or lumbar spine surgery
- •a history of hip, knee, or ankle pain in the previous two years
- •current pregnancy
- •systemic joint disease (e.g. rheumatologic or neurological disorders)
- •vestibular or other balance disorders
- •ongoing treatment for inner ear, sinus, or upper respiratory infection
- •concussion within the previous three months
- •a history of falls or fear of falling
- •a need for any form of walking aids (cane, walker)
研究组 & 干预措施
Spinal Stabilization Exercise Program
Participants in the spinal stabilization exercise group will be instructed to perform four exercises in total, one exercise from each of the following four categories: (a) abdominal bracing, (b) quadruped, (c) prone plank, and (d) side plank exercises. Each exercise will be progressed and advanced in difficulty by increasing repetitions, hold times, and/or extremity movements.
The progression of exercises will be based on the participants' performance at each supervised physical therapy session based on pre-established criteria by Hicks et al. (2005).
干预措施: Exercises (Other)
General Exercises Program
Participants in the general exercise group will perform a range of motion (ROM) and flexibility exercises of low back and lower extremities. Each participant will be instructed to perform four exercises in total, one exercise from each of the following four categories: (a) knee to chest, (b) lower trunk rotation, (c) prone press-ups, and (d) hamstring stretch exercises. These exercises will be progressed by increasing repetitions and pain-free ROM.
干预措施: Exercises (Other)
结局指标
主要结局
Change on dynamic balance
时间窗: Change from baseline at two weeks, four weeks, and eight weeks post intervention.
Dynamic balance measured by the Y-balance Test (YBT). Dynamic balance is quantified by measuring how far the reach indicator is placed relative to the stance platform while maintaining a unilateral stance. A farther reach distance is indicative of greater dynamic balance. To score each of the three directions, the reach distances (measured in cm) are averaged and normalized to the participant's leg length. As such, YBT scores are expressed as a percentage of leg length. Normalization is performed by dividing each reach distance by the participant's leg length and then multiplying by a hundred. Next, the composite score will be calculated by taking the average between right and left reach distances for all three directions and then summing the averages of the three reach directions. The score then will be divided by three times the average leg length and multiplied by 100.
Change on functional performance
时间窗: Change from baseline at two weeks, four weeks, and eight weeks post intervention.
Functional performance measured by Functional Movement Screen (FMS). Each participant will perform all 7 components of the FMS tests including deep squat, hurdle step, in-line lunge, shoulder mobility, active straight-leg-raise, trunk push-up, and trunk rotary stability tests. Participants will perform 3 trials for each of the 7 FMS tests, and the best score from the 3 trials will be recorded. In addition, each participant will perform 3 clearance screens. These 3 clearance screens evaluate pain and are graded as negative or positive. If a participant has no pain, the clearing test is considered negative. If there is an increase in pain, the clearing test is considered positive and the associated test will be scored zero. For movements that are scored on both limbs, the lower score will be used to compute the composite score. The total score of the 7 tests will be added together to get a composite score of the FMS.
Change on pain intensity level
时间窗: Change from baseline at two weeks, four weeks, and eight weeks post intervention.
pain intensity as perceived by the participant measured by the Numeric Pain Rating Scale (NPRS). The NPRS is an 11-point numerical scale (0-10), in which higher scores mean greater pain intensity. The possible scores on the NPRS range from zero representing no pain to 10 representing the worst imaginable pain. The NPRS will be administered verbally, and each participant will be asked to rate their pain intensity at present (i.e. current pain level).
Change on disability level
时间窗: Change from baseline at two weeks, four weeks, and eight weeks post intervention.
Modified Oswestry Low Back Pain Disability Questionnaire (OSW) to determine participants perceived disability level due to low back pain. The OSW is a self-reported ordinal scale measure that consists of 10 items assessing different aspects of pain and function related to the patient's LBP. Each item is scored on a six-point scale (0 to 5), with five representing the highest level of disability. The scores of the 10 items are then summed, with a maximum possible sum of 50 points. To obtain a percentage score, the sum is multiplied by two. Participants will be asked to use the OSW to rate their perceived level of disability at present.
次要结局
- Fear-avoidance beliefs(at baseline and will be used for descriptive purposes only.)
- Patient Reported Outcomes Measurement Information System (PROMIS-29)(at baseline and will be used for descriptive purposes only.)
研究者
Yousef Alshehre
Principal Investigator
Texas Woman's University