Motor Control Exercise and Patient Education for the Management of Chronic Low Back Pain in a Low-Resource Rural Nigerian Community: A Pilot Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in functional disability
研究概览
简要总结
The main purpose of this pilot single-blind randomized clinical trial is to assess the feasibility of implementing motor control exercise and patient education for the management of chronic low back pain (CLBP) in a low resource rural Nigerian community.
详细描述
This study will determine whether supervised exercise training emphasizing motor control exercise (MCE) approach and a designed patient education (PE) program based on the psychosocial approach will be feasible and acceptable in reducing pain intensity and functional disability among rural dwellers with CLBP in Nigeria.
Participants will be recruited and assigned to one of three intervention groups that include MCE group, PE group, or MCE plus PE gr using a simple random technique based on an electronic randomization table generated by a computer software program. Blinded assessment of all clinical outcomes will be performed at baseline and 6 weeks after randomization.
Primary outcomes include pain intensity and functional disability while secondary outcomes include overall treatment satisfaction.
Data will be analyzed using descriptive statistics, paired t-test, and ANOVA. All statistical analyses will be performed on SPSS (version 24.00) at an 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female between 18 and 65 years old.
- •Primary complaint of LBP experienced at least over the previous 3-month duration.
- •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
研究组 & 干预措施
Motor Control Exercise Plus Patient Education
Participants will receive a total of 12 sessions (2 sessions per week) of exercise program consisting of motor control training and group patient education session once a week (6 sessions) all over 6-weeks.
The motor control training will be aiming at improving function of specific muscles of the lumbopelvic region and the control of posture and movement.
The patient education program will be aiming to provide non-threatening information to enable patients to better understand their pain, change any unhelpful beliefs about LBP, and integrate self-management and active coping strategies that deals with fear avoidance behavior and catastrophic thought.
In addition, participants will also perform stretching exercises and instructed to perform continuous overground walk.
干预措施: Motor Control Exercise (Behavioral)
Motor Control Exercise Plus Patient Education
Participants will receive a total of 12 sessions (2 sessions per week) of exercise program consisting of motor control training and group patient education session once a week (6 sessions) all over 6-weeks.
The motor control training will be aiming at improving function of specific muscles of the lumbopelvic region and the control of posture and movement.
The patient education program will be aiming to provide non-threatening information to enable patients to better understand their pain, change any unhelpful beliefs about LBP, and integrate self-management and active coping strategies that deals with fear avoidance behavior and catastrophic thought.
In addition, participants will also perform stretching exercises and instructed to perform continuous overground walk.
干预措施: Patient Education (Behavioral)
Motor Control Exercise
Participants will receive the same motor control exercise program described in the patient education and motor control exercise group.
In addition, participants will also perform stretching exercises and instructed to perform continuous overground walk.
干预措施: Motor Control Exercise (Behavioral)
Patient Education
Participants will receive the same patient education program described in the motor control exercise plus patient education group.
In addition, participants will also perform stretching exercises and instructed to perform continuous overground walk.
干预措施: Patient Education (Behavioral)
结局指标
主要结局
Change in functional disability
时间窗: Baseline and 6 weeks after beginning treatment.
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 and 6 weeks after beginning treatment.
Pain Intensity will be measured by an 11-point (0-10) Numerical Pain Rating Scale (NPRS).
次要结局
- Patient satisfaction(6 weeks after beginning treatment.)
研究者
Aminu A. Ibrahim
Doctoral Student
Bayero University Kano, Nigeria