The Effect of Adding Lumbar Extension Strengthening to a Program of Manual Therapy & Motor Control Exercise in Individuals With Chronic Low Back Pain: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Modified Oswestry Disability Index (mODI)
研究概览
简要总结
The goal of this clinical trial is to determine the effect of adding lumbar strengthening exercises to a program of manual therapy and motor control exercises (standard therapy) in adults with chronic low back pain (cLBP). Researchers will compare individuals with cLBP that receive lumbar extensor strengthening in addition to standard therapy compared to standard therapy alone to determine if there are differences in patient reported outcomes, lumbar multifidus thickness, low back endurance, and healthcare utilization between the groups.
All participants will engage in 8-weeks of physical therapy, receiving manual therapy and motor control exercises. Those in the intervention group will have additional low back strengthening exercises.
详细描述
Purpose:
The purpose of this study is to determine the effect of adding lumbar strengthening exercises to a program of manual therapy and motor control exercises in individuals with chronic low back pain.
Primary Aim:
- Compare patient reported outcomes in individuals with cLBP that receive lumbar extensor strengthening in addition to a standard program of manual therapy & motor control exercises compared to manual therapy & motor control exercises alone.
Secondary Aims:
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
- None
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
- •Tricare Beneficiary
- •18-65 years old
- •LBP ≥ 3 months without symptoms below the knee
- •mODI ≥ 24%
- •English speaking
- •Available to actively take part in the study for 12 weeks
排除标准
- •History of spine surgery or expecting spinal surgery
- •Suspected or confirmed serious pathology (infection, cancer, fracture, cauda equina)
- •Diagnosis of any vertebral fracture in the last 6 months
- •Osteoporosis requiring pharmacologic treatment other than vitamin D, calcium supplements, or bisphosphonates
- •History of any bone-related cancer or cancer that metastasized to the bone
- •Diagnosed rheumatological or inflammatory disease
- •Progressive neurological disease
- •Leg pain as the primary complaint (radiculopathy, peripheral vascular disease, stenosis)
- •Contraindications to exercise and manual therapy
- •Currently pregnant, self-reported or post-partum within the past 6 months
- •Received physical therapy treatment for LBP in the past 6 months
- •In the last 3 months, received injections, nerve ablation or blocks or is seeking such services
- •Uncontrolled drug/alcohol addiction
- •Currently under litigation related to cLBP
- •Pending or expecting a Medical Evaluation Board (MEB)
- •Retiring from the military within 18 months
结局指标
主要结局
Modified Oswestry Disability Index (mODI)
时间窗: Enrollment, 4, 8, 12, and 26-weeks
A 10-item disability questionnaire administered to evaluate the patient's symptoms and the functional impact of low back pain. Each item is scored on a 0-5 Likert scale. The total score is converted to a 0-100% disability index, with 0% indicating no functional limitation and 100% representing complete disability or a bedbound state.
次要结局
- PROMIS-29(Enrollment, 4, 8, 12, and 26-weeks)
- Lumbar Spine Instability Questionnaire (LSIQ)(Enrollment)
- Patient Acceptable Symptom State (PASS)(Enrollment, 4, 8, 12, and 26-weeks)
- Healthcare Utilization(Enrollment, 4, 8, 12, 26-weeks)
- Lumbar Multifidus Thickness: L4-L5, L5-S1 bilaterally(Enrollment, 8, and 12-weeks)
- Back Endurance(Enrollment, 8, and 12-weeks)
研究者
Benjamin Campbell
Physical Therapist
Brooke Army Medical Center