跳至主要内容
临床试验/NCT01765777
NCT01765777招募中不适用

Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients With Chronic Lower Back Pain

New York Institute of Technology2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
48
试验地点
2
主要终点
10 cm visual analog scale for quantitative back pain

研究概览

简要总结

The purpose of the research study entitled "Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients with Chronic Lower Back Pain" is to investigate the hypothesis that combined treatment with both osteopathic manipulative medicine (OMM) and phototherapy will provide greater pain relief for patients with chronic lower back pain, as compared with standard medical management or either treatment alone.

详细描述

The research has demonstrated separately that phototherapy and osteopathic manipulative medicine (OMM) are effective in reducing chronic low back pain, However there has not been any research to evaluate whether the interaction of the two treatment approaches together can provide enhanced pain relief. In A Meta-analysis of the Efficacy of Phototherapy in Tissue Repair, Fulop et.al.(1) from the Department of Physical Therapy, School of Health Professions, New York Institute of Technology (NYIT) concluded that "phototherapy is a highly effective form of treatment for tissue repair, with stronger supporting evidence resulting from experimental animal studies than human studies" (Fulop, p. 695, 699). Further review of the literature by Fulop et. al. (2) focused on the question of pain relief in relation to phototherapy, and the conclusion was that pain from various etiologies can be effectively relieved by phototherapy. The U.S. Food and Drug Administration has cleared biostimulation lasers (a.k.a. low level laser therapy [LLLT], cold lasers, soft lasers, or laser acupuncture devices) for marketing as "adjunctive devices for the temporary relief of pain" (3). Thus, both health practitioners and the lay public have access to and may potentially obtain and use phototherapy devices manufactured by various companies. Other research protocols by Gur, A et. al. (4) and Djavid, GE et. al. (5) evaluated patients with chronic low back pain in relation to the combined effectiveness of low level laser therapy and exercise. These studies showed positive results with the combined approaches.

Osteopathic physicians utilize an approach to the treatment of patients called osteopathic manipulative medicine (OMM). The osteopathic physician will diagnose somatic dysfunction, and then treat the dysfunctions found with one or more of several OMM treatment approaches. The American Osteopathic Association (AOA) published in 2009 the "Guidelines for Osteopathic Manipulative Treatment (OMT) for Patients with Low Back Pain." These guidelines are available both through the AOA and the Agency for Healthcare Research and Quality (AHRQ), National Guideline Clearinghouse (6). This guideline (6) specifically addresses the "efficacy of osteopathic manipulation treatment in reducing low back pain" (p. 2). A review of the literature was performed, and after selection a total of "six trials, involving eight osteopathic manipulative treatment (OMT) vs control treatment comparisons, were included" in the meta-analysis (p. 2-3). The major recommendation stated in the guideline is that "osteopathic manipulative treatment (OMT) be utilized by osteopathic physicians for musculoskeletal causes of back pain, i.e., to treat the diagnoses of somatic dysfunctions related to the low back pain" (p.4). In addition, the meta-analysis performed did show that OMT for patients with low back pain led to statistically significant reduction in pain (p. 5). Thus, the potential for a complementary approach to patient care in cases of chronic low back pain exists. Yet, no studies to date have specifically evaluated this particular hypothesis regarding OMT and phototherapy for patients with chronic low back pain. The purpose of this research is to evaluate this question of enhanced combined efficacy for the overall benefit of patients.

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 (Investigator)

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

入选标准

  • Age range: 18 - 65 years old
  • Subjects with constant or intermittent nonspecific lower back pain for a minimum of three (3) months duration.

排除标准

  • Prospective subjects with a diagnosis of the following potential underlying causes of lower back pain: ankylosing spondylitis, cancer or a history of a histologically demonstrated malignant carcinoma, cauda equine syndrome, herniated disc, spinal fracture, or spinal osteomyelitis.
  • Prospective subjects who have undergone surgery of the lower back in the preceding three (3) months.
  • Prospective subjects who have received worker's compensation in the preceding three (3) months, or are involved in litigation involving concerns of lower back.
  • Prospective subjects who are pregnant.
  • Prospective subjects who have been a patient receiving any osteopathic manipulative medicine (OMM) treatment at the clinical trial site in the previous three (3) months, or on greater than three (3) occasions in the preceding year.
  • Prospective subjects who have ever been an employee at the clinical trial site.
  • Prospective subjects who have received spinal manipulation in the previous three (3) months, or on greater than three (3) occasions in the preceding year.
  • Prospective subjects who are currently involved in a physical therapy rehabilitation program.
  • Prospective subjects who have photosensitivity.

结局指标

主要结局

10 cm visual analog scale for quantitative back pain

时间窗: 8 weeks

VAS Data collected at all visits

SF-36 Health Survey to measure Quality of Life

时间窗: 8 weeks

SF-36 survey data collected at 3 points

The Oswestry Back Questionnaire to measure qualitative back pain

时间窗: 8 weeks

Oswestry questionnaire data collected at 3 points

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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