A Randomized Controlled Trial of Osteopathic Manipulative Treatment and Ultrasound Physical Therapy for Chronic Low Back Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 455
- 试验地点
- 1
- 主要终点
- Change in Visual Analogue Scale Score for Pain Over 12 Weeks (OMT vs Sham OMT)
研究概览
简要总结
The purpose of this study is to determine whether osteopathic manipulative treatment (a type of spinal manipulative therapy used by osteopathic physicians) and ultrasound physical therapy are effective in the treatment of chronic low back pain.
详细描述
The purpose of this study is to determine whether osteopathic manipulative treatment (a type of spinal manipulative therapy used by osteopathic physicians) and ultrasound physical therapy are effective in the treatment of chronic low back pain. This study uses a 2X2 factorial design to test the hypotheses.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must give a positive response to the question: "Have you had low back pain constantly or on most days for the last three months?"
- •Must identify the low back as the primary site of pain
- •Must agree to not receive any of the following outside of the study during the period of participation: osteopathic manipulative treatment, chiropractic adjustment (including "mobilization" or "manipulation"), physical therapy
- •Women must not be pregnant or plan to become pregnant during the period of study participation (a negative pregnancy test and willingness to maintain an acceptable method of contraception will be required)
排除标准
- •History of any of the following conditions which may be underlying causes of low back symptoms: cancer, spinal osteomyelitis, spinal fracture, herniated disc, ankylosing spondylitis, cauda equina syndrome
- •History of surgery involving the low back within the past year or planned low back surgery in the future
- •History of receiving Workers' Compensation benefits within the past three months
- •Involvement in current litigation relating to back problems
- •Current pregnancy or plan to become pregnant during the course of participation in the study
- •Any of the following that may limit a provider's choice of osteopathic manipulative treatment techniques or hamper compliance with the study protocol: angina or congestive heart failure symptoms that occur at rest or with minimal activity, history of a stroke or transient ischemic attack within the past year
- •Any of the following that may represent potential contraindications to receiving ultrasound physical therapy: implantation of a cardiac pacemaker, implantation of artificial joints or other biomedical devices, active bleeding or infection in the low back, pregnancy
- •Use of intravenous, intramuscular, or oral corticosteroids within the past month
- •History of osteopathic manipulative treatment, chiropractic adjustment, or physical therapy within the past three months or on more than three occasions during the past year
- •Practitioner or student of any of the following: osteopathic medicine (D.O.) allopathic medicine (M.D.), chiropractic (D.C.), physical therapy
研究组 & 干预措施
A (Active OMT and active (UST)
Subjects in this group received active osteopathic manipulation and active ultrasound physical therapy
干预措施: A. Active OMT and active UST (Procedure)
B (Sham OMT and active UST)
Subjects in this group received sham osteopathic manipulation and active ultrasound physical therapy
干预措施: B. Sham OMT and active UST (Procedure)
C (Active OMT and sham UST)
Subjects in this group received active osteopathic manipulation and sham ultrasound physical therapy
干预措施: C. Active OMT and sham UST (Procedure)
D (Sham OMT and sham UST)
Subjects in this group received sham osteopathic manipulation and sham ultrasound physical therapy
干预措施: D. Sham OMT and sham UST (Procedure)
结局指标
主要结局
Change in Visual Analogue Scale Score for Pain Over 12 Weeks (OMT vs Sham OMT)
时间窗: 12 weeks
Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a "better" outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a "worse" outcome). However, only those "better" outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%).
Change in Visual Analogue Scale Score for Pain Over 12 Weeks (Active UST vs Sham UST)
时间窗: 12 weeks
Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a "better" outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a "worse" outcome). However, only those "better" outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%).
次要结局
- Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 4)(4 weeks)
- Roland Morris Disability Questionnaire (UST and Sham UST - Week 12)(12 weeks)
- Roland Morris Disability Questionnaire (UST and Sham UST - Week 4)(4 weeks)
- Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 4)(4 weeks)
- Work Disability (OMT and Sham OMT - Week 12)(12 weeks)
- Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 8)(8 weeks)
- Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 12)(12 weeks)
- Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 12)(12 weeks)
- Work Disability (OMT and Sham OMT - Week 4)(4 weeks)
- Work Disability (UST and Sham UST - Week 4)(4 weeks)
- Work Disability (UST and Sham UST - Week 8)(8 weeks)
- Satisfaction With Back Care (OMT and Sham OMT - Week 12)(12 weeks)
- Roland Morris Disability Questionnaire (UST and Sham UST - Week 8)(8 weeks)
- Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 8)(8 Weeks)
- Work Disability (OMT and Sham OMT - Week 8)(8 weeks)
- Satisfaction With Back Care (OMT and Sham OMT - Week 4)(4 weeks)
- Satisfaction With Back Care (UST and Sham UST - Week 4)(4 weeks)
- Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 8)(8 weeks)
- Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 4)(4 Weeks)
- Satisfaction With Back Care (UST and Sham UST - Week 8)(8 weeks)
- Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 12)(12 Weeks)
- Work Disability (UST and Sham UST - Week 12)(12 weeks)
- Satisfaction With Back Care (OMT and Sham OMT - Week 8)(8 weeks)
- Satisfaction With Back Care (UST and Sham UST - Week 12)(12 weeks)
研究者
John C. Licciardone, D.O., M.S., M.B.A.
Director, Osteopathic Research Center
University of North Texas Health Science Center