Effects of Patient Education and Motor Control Exercise on Selected Clinical and Psychosocial Variables Among Rural Community-dwelling Adults With Chronic Low Back Pain: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in functional disability
研究概览
简要总结
Low back pain (LBP) is the leading cause of years lived with disability globally with increasing concern about its impact in low- and middle-income countries like those situated in Africa where most people are living in rural areas with limited access to health care. Epidemiological studies in Nigeria suggest that the burden of chronic low back pain (CLBP) in rural areas is greater than in urban areas, with both biomechanical and psychological factors being implicated. However, despite the burden of CLBP in rural Nigeria, rehabilitation services are lacking even at the rural primary healthcare centers due to the absence of physiotherapists. Current clinical practice guidelines unanimously recommend education including instruction on self-management options, and exercise as frontline interventions to help individuals with CLBP. However, the specific content of these interventions are rarely described. Patient education (PE) strategies incorporating both biomedical and psychosocial information have been shown to be beneficial for CLBP. Moreover, exercises in the form of motor control exercises (MCEs) have been proven to be effective for CLBP. However, RCTs examining the effects of PE and MCE individually or in combination among rural community-dwelling adults with CLBP are scarce.
The purpose of this study is to determine the effects of PE and MCE program on selected clinical and psychosocial variables among rural community-dwelling adults with nonspecific CLBP.
详细描述
Participants will be recruited and assigned to one of three intervention groups that include PE plus MCE group, MCE group, or PE group using a block random technique based on an electronic randomization table generated by a computer software program. Blinded assessment of all outcomes will be performed at baseline, 8 weeks after randomization and at 3, 6 and 12 months follow-up.
Primary outcomes will be functional disability and pain intensity. Secondary outcomes will be quality of life, global perceived recovery, fear-avoidance beliefs, pain catastrophizing, back pain consequences beliefs, and physical performance (finger-floor test, repeated sit-to-stand test, and the 50-foot walk test) Data will be analyzed using descriptive and inferential (mixed-model ANOVA/linear mixed-effects model) statistics. All statistical analyses will be performed on IBM SPSS Statistics ver. 23.0 (IBM Co., Armonk, NY, USA) at alpha level of 0.05.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to participants' treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female between 16 and 70 years old.
- •Primary complaint of LBP with or without leg pain experienced at least over the previous 3 months duration.
- •Mean LBP intensity at least ≥ 3 on numerical rating scale during the past week.
- •Ability to read/understand English or Hausa language.
排除标准
- •Previous history of thoracic spine or lumbosacral spine surgery.
- •Any neurological findings indicating radiculopathy.
- •Evidence of serious spine pathology (e.g. tumor, infection, fracture, spinal stenosis, inflammatory disease).
- •Unstable or severe disabling chronic cardiovascular and pulmonary disease.
- •History of serious psychological or psychiatric illness.
- •Current pregnancy.
结局指标
主要结局
Change in functional disability
时间窗: Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up
Functional disability will be measured by Oswestry disability index (ODI). The questionnaire consists of 10 items with each item having six statements. All scores are summed, then multiplied by two to obtain the index (range 0 to 100) with higher score indicating greater disability.
Change in pain Intensity
时间窗: Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up
Pain Intensity will be measured by an 11-point (0-10) Numerical Pain Rating Scale (NPRS), in which 0 represents "no pain" and 10 represents "worst pain imaginable".
次要结局
- Change in quality of life(Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up)
- Change in fear-avoidance beliefs(Baseline, 8 weeks after beginning treatment, and 3-month follow-up)
- Change in pain catastrophization(Baseline, 8 weeks after beginning treatment, and 3-month follow-up)
- Change in mobility of the spine and pelvis(Baseline and 8 weeks after beginning treatment)
- Change in functional performance of sit-to-stand(Baseline and 8 weeks after beginning treatment)
- Change in global impression of recovery(Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up)
- Change in back pain consequences beliefs(Baseline, 8 weeks after beginning treatment, and 3-month follow-up)
- Change in functional performance of 50-foot walk(Baseline and 8 weeks after beginning treatment)
研究者
Aminu A. Ibrahim
Doctoral Student
Bayero University Kano, Nigeria