The Addition of Electric Dry Needling and Spinal Manipulation to Impairment-based Manual Therapy, Stretching, Strengthening and Electrothermal Modalities for Patients With Lumbar Spinal Stenosis: a Multi-randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Change in low back pain (NPRS) (Rating Score)
研究概览
简要总结
The purpose of this research is to compare two different approaches for treating patients with lumbar spinal stenosis: electric dry needling and thrust manipulation versus impairment-based manual therapy, stretching, strengthening and electrothermal modalities. Physical therapists commonly use all of these techniques to treat lumbar spinal stenosis. This study is attempting to find out if one treatment strategy is more effective than the other.
详细描述
Patients with lumbar spinal stenosis will be randomized to receive 1-2 treatment sessions per week for 6 weeks (up to 12 sessions total) of either: (1) electric dry needling and thrust manipulation or (2) impairment-based manual therapy, stretching, strengthening and electrothermal modalities
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult over the age of 50 years old that is able to read, write and speak English
- •Symptoms of neurogenic claudication (pain in the buttock, thigh, or leg during ambulation that improves with rest) or radicular leg symptoms with associated neurological deficits on the physical examination for at least 12 weeks.
- •Confirmatory imaging (i.e. magnetic resonance imaging (MRI), computed tomography (CT), myelography, ultrasound or X-ray of either central or lateral (foraminal) lumbar spinal stenosis at one or more levels in the lumbar spine.
排除标准
- •Report of red flags to manual physical therapy to include: severe hypertension, infection, ankylosing spondylitis, neoplasm, uncontrolled diabetes, peripheral neuropathy, heart disease, stroke, chronic, ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc.
- •Severe vascular, pulmonary, or coronary artery disease limiting participation in exercise, to include a walking program (including presence of absolute contraindications to submaximal exercise testing)
- •Severe degenerative stenosis with intractable pain and progressive neurological dysfunction
- •Lumbar spinal stenosis not caused by degeneration
- •Radiographic evidence of instability, degenerative spondylolisthesis, fracture or scoliosis of more than 15°
- •Lumbar herniated disc diagnosis during the last 12 months.
- •Previous lumbar surgery for lumbar spinal stenosis or instability (i.e. previous lumbar fusion, lumbar microdiscectomy, lumbar foraminotomy, lumbar laminectomy, etc.)
- •Psychiatric disorder or cognitively impaired.
结局指标
主要结局
Change in low back pain (NPRS) (Rating Score)
时间窗: baseline, 2-weeks, 6-weeks and 3-months
Baseline score must exceed 2/10 to be included in the study.
Change in Oswestry Disability Index
时间窗: baseline, 2-weeks, 6-weeks and 3-months
The Oswestry Disability Index (ODI) includes 10 questions, each worth 0-5 points with maximum score of 50 points possible. The greater the score, the worse the disability. Baseline score must exceed 10/50 points to be included in the study.
次要结局
- Change in Medication Intake (Frequency of medication intake in last week)(baseline, 3 months)
- Change in Global Rating of Change Score(2-weeks, 6-weeks and 3-months)
- Change in Roland Morris Disability Index(baseline, 2-weeks, 6-weeks and 3-months)
研究者
James Dunning, DPT, MSc, FAAOMPT
Primary Investigator and President of Spinal Manipulation Institute and Dry Needling Institute of the American Academy of Manipulative Therapy
Alabama Physical Therapy & Acupuncture