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

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ClinicalTrials.gov Identifier: NCT01765777
Recruitment Status : Recruiting
First Posted : January 10, 2013
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
New York Institute of Technology

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Lower Back Pain Procedure: Osteopathic Manipulative Medicine Procedure: Phototherapy Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients With Chronic Lower Back Pain
Study Start Date : June 2011
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
No Intervention: Control Group
Subjects in this arm continue with standard medical care
Experimental: Osteopathic Manipulative Medicine Group
Subjects in this arm will receive an OMM intervention.
Procedure: Osteopathic Manipulative Medicine
Other Name: OMM,OMT

Experimental: Phototherapy Group
Subjects in this arm will receive a phototherapy intervention.
Procedure: Phototherapy
Other Names:
  • Low level laser therapy
  • LLLT

Experimental: OMM and Phototherapy Group
Subjects in this arm will receive both the OMM and phototherapy interventions.
Procedure: Osteopathic Manipulative Medicine
Other Name: OMM,OMT

Procedure: Phototherapy
Other Names:
  • Low level laser therapy
  • LLLT




Primary Outcome Measures :
  1. 10 cm visual analog scale for quantitative back pain [ Time Frame: 8 weeks ]
    VAS Data collected at all visits

  2. SF-36 Health Survey to measure Quality of Life [ Time Frame: 8 weeks ]
    SF-36 survey data collected at 3 points

  3. The Oswestry Back Questionnaire to measure qualitative back pain [ Time Frame: 8 weeks ]
    Oswestry questionnaire data collected at 3 points



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01765777


Contacts
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Contact: Patricia S Kooyman, D.O. 516-686-1309 pkooyman@nyit.edu
Contact: Peter Douris, PT,DPT, EdD 516-686-7688 pdouris@nyit.edu

Locations
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United States, New York
New York Institute of Technology Recruiting
Old Westbury, New York, United States, 11568
Contact: Brian Harper, MD, MPH    516-686-4018    bharper@nyit.edu   
Principal Investigator: Patricia S Kooyman, D.O.         
Sub-Investigator: Peter Douris, PT,DPT, EdD         
Sub-Investigator: Min-Kyung Jung, Ph.D.         
Sub-Investigator: William Werner, P.T., D.P.T.         
Sub-Investigator: Michael Terzella, D.O.         
Sub-Investigator: Sheldon Yao, D.O.         
Sub-Investigator: Theodore Flaum, D.O.         
Sub-Investigator: To Shan Li, D.O.         
Sub-Investigator: Michelle Farella-Accurso, PT, D.P.T.         
Sub-Investigator: Christine Flynn, PT, DPT, NCS         
Sub-Investigator: Shari Zeleznik, D.P.T.         
Sponsors and Collaborators
New York Institute of Technology
Investigators
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Principal Investigator: Patricia S Kooyman, D.O. New York Institute of Technology

Additional Information:
Publications:
Patterson, MM, PhD, Editorial - Research in OMT: What is the question and do we understand it?, JAOA, January 2007, Vol. 107, No. 1, pp. 8-11.
Cameron, Michelle H., Physical Agents in Rehabilitation: From Research to Practice, Third Edition, Chapter 12, Electromagnetic Radiation: Lasers and Light, Saunders Elsevier, 2009.

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Responsible Party: New York Institute of Technology
ClinicalTrials.gov Identifier: NCT01765777    
Other Study ID Numbers: BHS-740
First Posted: January 10, 2013    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Keywords provided by New York Institute of Technology:
Low back pain
Lower back pain
Chronic back pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms