Hip Posterolateral Complex Strengthening in Patients With Chronic Nonspecific Low Back Pain: a Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
Chronic nonspecific low back pain is an important health condition with a high prevalence worldwide and it is associated with enormous direct and indirect costs to the society. Clinical practice guidelines show that many interventions are available to treat patients with chronic low back pain, but the vast majority of these interventions have a modest effect in reducing pain and disability. A biomechanical approach that has been raised is that a weakness of the hip abductors, extensors, and lateral rotators musculature (posterolateral complex - PLC) would lead to excessive contralateral pelvic drop during weight-bearing activities such as walking, running, climbing up or downstairs, generating an overload in the lumbar area. Although the strengthening of the hip PLC is largely used in clinical practice for treating patients with hip and knee injuries, there is still a lack of evidence regarding patients with low back pain. Therefore, questions remain about the efficacy of the hip dynamic stabilization as an additional intervention to conventional treatment in a well design trial with statistic power.
详细描述
Randomised clinical trial will be held in following the recommendations of the CONSORT (Consolidated Standards of Reporting Trials). Will be recruited participants of both genders, aged between 18 and 60 years, with and without chronic nonspecific low back pain for over 3 months without irradiation for lower limbs. Potential participants with chronic nonspecific low back pain will be referred by their doctors orthopedic surgeons and/or rheumatologists that will make all the assessments and routine exams, for example, Imaging tests, prescription drugs and referral to physical therapy care. The characteristics of participants will be collected through an evaluation form specially designed for this study. This assessment form will contain issues related to demographic and anthropometric data, plus information about the clinical picture of the participants, as for example the use of medications, physical activity level, educational level, prior history of back pain and duration of symptoms.The clinical outcomes will be obtained at the completion of treatment (6 weeks) and at 3, 6, and 12 months after randomization.
The data will be collected by a blinded assessor. The statistical analysis will follow the intention-to-treat principles.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Will be included 70 patients of both sexes, adults with medical diagnosis divided into two groups: Group A consisted of 35 patients use receive conventional physical therapy plus the addition of hip PLC strengthening and group B consisted of 35 patients also only use conventional physical therapy
排除标准
- •Will be excluded from the study patients who have neurological or osteoarticular disease preventing the ambulation of these individuals.
研究组 & 干预措施
Conventional physical therapy plus HPCS
Conventional physical therapy (Combination of manual therapy techniques and exercises for spinal segmental stabilization) plus the addition of hip posterolateral complex strengthening (HPCS)
干预措施: Conventional physical therapy plus HPCS (Other)
Conventional physical therapy
Conventional physical therapy (Combination of manual therapy techniques and exercises for spinal segmental stabilization)
干预措施: Conventional physical therapy (Other)
结局指标
主要结局
Pain
时间窗: 6 weeks
The numerical visual scale evaluates levels of intensity of pain perceived by the patient through a range of 11 points (ranging from 0 to 10), 0 being no pain and 10 rank as the worst pain possible. Participants will be instructed to report the level of pain intensity based on the last 7 days.
Disability
时间窗: 6 weeks
The Roland Morris disability questionnaire is an instrument widely used in research and clinical practice for evaluation of functional disability associated with back pain through 24 issues that describe everyday situations in which patients have difficulty to carry out due low back pain.
次要结局
- Strength(6 weeks)
- Functioning (activities and participation)(6 weeks)
- Movement analysis with a 2-D system(6 weeks)
研究者
Mansueto Gomes Neto
Dr Mansueto Gomes Neto
Federal University of Bahia