Effectiveness of Lumbar Anteroposterior Mobilizations on Pain and Functional Performance in Lumbosacral Spondylolisthesis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Numerical Pain Rating Scale (NPS)
研究概览
简要总结
Spondylolisthesis has been recognized as one of the pathoanatomical and pathobiomechanical etiologies of low back pain (LBP). The effectiveness and use of various manual therapies are well established in literature in the management of lumbosacral spondylolisthesis, including thoracic mobilization, sacral mobilization, and posteroanterior mobilization of L4 vertebrae, Although anteroposterior mobilizations of L5 are also mentioned in lumbosacral spondylolisthesis, sufficient literature still needs to be provided. This study aims to assess the effectiveness of lumbar anteroposterior mobilizations [LAPMs] in relieving pain and improving functions irrespective of other conservative treatments involving conventional exercises and mobilization among patients with lumbosacral anterolisthesis.
Patients will be recruited from New OPD, Department of Physical Medicine and Rehabilitation, PGIMER Chandigarh. Patients will be thoroughly explained about the study and given a patient information sheet before participation. Then, they will be asked to sign a written informed consent and assent form. Patient screening will be done as per inclusion and exclusion criteria. All the subjects will undergo a complete musculoskeletal evaluation, and patients will be enrolled as per their eligibility criteria. All the patients will be evaluated for the undermentioned parameters using a numerical pain rating scale, which will be used to assess both lower back and leg pain. Muscle flexibility and range of motion will be evaluated by finger-tip to floor measurements in centimeters, and functional performance will be evaluated using the Modified Oswestry disability index and Roland Morris disability questionnaire. Patients will be randomly allocated to either of the two groups Interventional group and the Control group. Patients in both groups will be directed to physical therapy five times weekly. The control group will receive conventional physical therapy protocol including stretching manoeuvers for tightened muscles such as the piriformis, hip flexors, hamstring, and thoracolumbar fascia, depending on their level of muscle stiffness, William’s flexion exercises and Lumbar stabilization exercises under our supervision at the physiotherapy section, New OPD, PGIMER Chandigarh. The interventional group will receive lumbar anteroposterior mobilizations followed by conventional physical therapy protocol, including stretching manoeuvers, William’s flexion exercises, and lumbar stabilization exercises under our supervision at the physiotherapy section, New OPD, PGIMER Chandigarh. Both groups will also be advised to use moist heat at home. They will also be advised to follow back care, which includes avoidance of all activities and exercises involving the lumbar spinal extension of the spine. A lumbosacral brace in anti-lordotic posture during traveling and exertion will be recommended. Postural awareness will be given to maintain normal posture. All outcome measurements, Numerical pain rating scale for both lower back and leg pain, muscle flexibility and Range of motion using finger-tip-to-floor distance measurements in centimeters, and functional performance using Oswestry disability index questionnaire, Roland Morris disability questionnaire. This will be noted at baseline, 2nd week of exercise, and 4th week of the physical therapy program.
Statistics: Descriptive data will be calculated as mean and standard deviation. The level of significance of the tests will be considered by p < 0.05 with a 95% confidence interval (CI). The normality of the data will further be determined through the formal tests. Moreover, inter-group comparisons and non-normal cases will be examined via independent T-test and Mann–Whitney U test, respectively. A paired T-test and Wilcoxon signed-rank test will be employed for intra-group comparisons as per the normality of the data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with low back pain due to Lumbosacral spondylolisthesis with or without radiation to the lower limb for more than three months.
- •Patients having tenderness and irregularities in bony alignment, step sign positive
- •Plain Lumbosacral X-rays of forward slippage of L5 over S1 (Anterior/posterior/Lateral/oblique views) demonstrate fracture in pars interarticularis in oblique X-ray; standing lateral X-ray is used to determine the magnitude of forward slip.
排除标准
- •Recent Trauma
- •LSSL associated with neurological diseases like Guillain-Barre syndrome, Polio, Myasthenia gravis, Cauda equina
- •Bone tumors
- •Severe Rheumatism
- •Severe osteoporosis
- •Associated infections and injuries of the spine, pelvis, and lower limb.
- •Mental health disorders (delirium)
- •Drug abuse
- •Any other complication that could affect their interventions.
- •Patients who had a history of previous lumbar surgery.
结局指标
主要结局
Numerical Pain Rating Scale (NPS)
时间窗: DURATION of the prtocol is 4 weeks. Assessment will be done at baseline, 2nd, and 4th weeks of the physical therapy program.
Oswestry disability index questionnaire (ODI)
时间窗: DURATION of the prtocol is 4 weeks. Assessment will be done at baseline, 2nd, and 4th weeks of the physical therapy program.
Rolando Morris disability questionnaire (RMDQ)
时间窗: DURATION of the prtocol is 4 weeks. Assessment will be done at baseline, 2nd, and 4th weeks of the physical therapy program.
Fingertip-to-floor test (in cm)
时间窗: DURATION of the prtocol is 4 weeks. Assessment will be done at baseline, 2nd, and 4th weeks of the physical therapy program.
次要结局
- Rolando Morris disability questionnaire (RMDQ)(Fingertip-to-floor test (in cm))
研究者
Neha Suri
Post Graduate Institute of Medical Education and Research
