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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by New York Institute of Technology
Sponsor:
Information provided by (Responsible Party):
New York Institute of Technology
ClinicalTrials.gov Identifier:
NCT01765777
First received: January 8, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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 Intervention
Chronic Lower Back Pain
Procedure: Osteopathic Manipulative Medicine
Procedure: Phototherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients With Chronic Lower Back Pain

Resource links provided by NLM:


Further study details as provided by New York Institute of Technology:

Primary Outcome Measures:
  • 10 cm visual analog scale for quantitative back pain [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • SF-36 Health Survey to measure Quality of Life [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • The Oswestry Back Questionnaire to measure qualitative back pain [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: June 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group
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: Osteopathic Manipulative Medicine 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765777

Contacts
Contact: Patricia S Kooyman, D.O. 516-686-1309 pkooyman@nyit.edu
Contact: Peter Douris, P.T., D.P.T., Ed.D. 516-686-7688 pdouris@nyit.edu

Locations
United States, New York
New York Institute of Technology Recruiting
Old Westbury, New York, United States, 11568
Contact: Ronald Manning, J.D.    516-686-7551    rmanning@nyit.edu   
Principal Investigator: Patricia S Kooyman, D.O.         
Sub-Investigator: Peter Douris, P.T., D.P.T., Ed.D.         
Sub-Investigator: Andrea Watson, D.O.         
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: Wolfgang Gilliar, D.O.         
Sub-Investigator: To Shan Li, D.O.         
Sub-Investigator: Michelle Farella-Accurso, P.T., D.P.T.         
Sub-Investigator: Christine Flynn, P.T., D.P.T., N.C.S.         
Sub-Investigator: Shari Zeleznik, D.P.T.         
Sponsors and Collaborators
New York Institute of Technology
Investigators
Principal Investigator: Patricia S Kooyman, D.O. New York Institute of Technology
  More Information

Additional Information:
Publications:

Responsible Party: New York Institute of Technology
ClinicalTrials.gov Identifier: NCT01765777     History of Changes
Other Study ID Numbers: BHS-740
Study First Received: January 8, 2013
Last Updated: January 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New York Institute of Technology:
Low back pain
Lower back pain
Chronic back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014