Osteopathic Manipulative Treatment Compared to Ibuprofen for the Treatment of Acute Low Back Pain in the Emergency Department: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
Acute low back pain is the fifth most common presenting complaint to the emergency department, accounting for approximately 4.4% of annual visits. The treatment for acute low back pain is often NSAIDs or other analgesic medications. Osteopathic Manipulative Treatment (OMT) has been shown to be an effective treatment modality for acute low back pain, however, it's use in the emergency department setting is not well described. The adjunct of OMT has the potential to increase patient satisfaction, decrease length of stay and decrease the number of unnecessary prescription medications. We plan to investigate the use of OMT in the setting of acute complaints of low back pain in comparison to the use of nonsteroidal anti-inflammatory drugs (NSAIDs) as primary treatment modality. The study will be a non-blinded randomized-control trial and will take place in an academic tertiary care center in urban Philadelphia, PA over an approximate one-year timespan. We will utilize osteopathic-trained attending and resident physicians to perform the manipulation. Patients will be randomized into one of three treatment groups: appropriately dosed NSAID therapy alone, OMT in addition to NSAID therapy, or OMT alone. The primary outcome will be the difference in pain score before and after treatment using a VAS scale. Secondary outcomes will include patient and physician satisfaction immediately following treatment. Results will be shared by means of publication to the osteopathic and allopathic communities.
详细描述
The goal of this study is to describe the efficacy of Osteopathic Manipulative Treatment (OMT) compared to NSAIDs in decreasing pain in adults with acute low back pain in the emergency department (ED). This study would provide an additional novel adjunct for pain management of painful procedures in the emergency department. Currently in the emergency department the complaint of low back pain comprises 4.4% of visits annually and is an area of patient dissatisfaction surrounding the pain management.
The primary aims of this project will be measure the level of pain pre and post procedure in adults receiving ibuprofen (NSAID), OMT, or OMT/ibuprofen for low back pain. Secondary aims include patient and physician post procedure satisfaction scores, length of stay in ED.
AIM 1: Measure the level of pain pre and post procedures in adults receiving ibuprofen, OMT, or OMT/Ibuprofen. Hypothesis: The level of pain for patients receiving OMT will be decreased to a greater extent that those receiving only NSAIDs for low back pain.
AIM2: Measure the patient and physician satisfaction with the adjunct of OMT in regard to ability to manage pain based on satisfaction scores from questionnaire. Hypothesis: There will be greater satisfaction in the patients receiving OMT and OMT/NSAIDs than those receiving only OMT alone.
This study will be a prospective, randomized- controlled trial of patients with acute low back pain in the ED of an urban, tertiary, academic medical center. Subjects will be randomized to one of three groups: Ibuprofen (800 mg), Ibuprofen (800 mg)/OMT, or OMT only for the treatment of acute low back pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients 18 years of age or older with the chief complaint of acute low back pain defined as symptom duration no longer than four weeks prior to ED presentation and having clinical findings of somatic dysfunction (muscle edema, erythema, bogginess, hypertonic muscles, asymmetry of tissue, pain with movement, severe/sharp tenderness).
排除标准
- •Patients will be excluded if they previously participated in the study, history of gastrointestinal bleed, allergies to NSAIDs, NSAID use 4 hours prior to arrival, history of or concern for spinal column fracture, current diagnosis of active malignancy or metastatic cancer, open skin wounds at the treatment location site, patients with neurological deficits related to acute back pain, pregnant women, individuals unable to take oral medications, temperature >38C, prisoners, those unable to consent, subjects under police custody, nursing home residents, non-English speaking patients.
研究组 & 干预措施
NSAID
Ibuprofen, 800 mg, one time dose
干预措施: Ibuprofen (Drug)
OMT/NSAID
Ibuprofen, 800 mg, one time dose
干预措施: Ibuprofen (Drug)
OMT/NSAID
Ibuprofen, 800 mg, one time dose
干预措施: Osteopathic manipulative treatment (Procedure)
OMT alone
low velocity osteopathic manipulative medicine
干预措施: Osteopathic manipulative treatment (Procedure)
结局指标
主要结局
Pain score
时间窗: 45 minutes
Difference in pain score before and after treatment using a Visual Analog Scale (VAS) scale (minimum 1, maximum 10, 10 being the worst)
次要结局
- Patient Satisfaction(45 minutes)
- Physician Satisfaction(45 minutes)
研究者
Megan Stobar-Gallagher
Attending Physician
Albert Einstein Healthcare Network