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

August 5, 2024 updated by: New York Institute of Technology
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Peter Douris, PT,DPT, EdD
  • Phone Number: 516-686-7688
  • Email: pdouris@nyit.edu

Study Locations

  • United States
    • New York
      • Old Westbury, New York, United States, 11568
        • Recruiting
        • New York Institute of Technology
        • Principal Investigator:
          • Patricia S Kooyman, D.O.
        • Sub-Investigator:
          • Peter Douris, PT,DPT, EdD
        • Sub-Investigator:
          • Min-Kyung Jung, Ph.D.
        • 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:
          • Christine Flynn, PT, DPT, NCS
        • Contact:
        • Sub-Investigator:
          • John Comeau, PT, D.P.T.
        • Sub-Investigator:
          • Rita Eng, PT, M.S.
        • Sub-Investigator:
          • Matthew Heller, D.O.
        • Sub-Investigator:
          • Jayme Mancini, D.O., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • OMM,OMT
Experimental: Phototherapy Group
Subjects in this arm will receive a phototherapy intervention.
Procedure: Phototherapy
Other Names:
  • LLLT
  • Low level laser therapy
Experimental: OMM and Phototherapy Group
Subjects in this arm will receive both the OMM and phototherapy interventions.
Procedure: Phototherapy
Other Names:
  • LLLT
  • Low level laser therapy
Procedure: Osteopathic Manipulative Medicine
Other Names:
  • OMM,OMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10 cm visual analog scale for quantitative back pain
Time Frame: 8 weeks
VAS Data collected at all visits
8 weeks
SF-36 Health Survey to measure Quality of Life
Time Frame: 8 weeks
SF-36 survey data collected at 3 points
8 weeks
The Oswestry Back Questionnaire to measure qualitative back pain
Time Frame: 8 weeks
Oswestry questionnaire data collected at 3 points
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York Institute of Technology

Investigators

  • Principal Investigator: Patricia S Kooyman, D.O., New York Institute of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2011

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 8, 2013

First Submitted That Met QC Criteria

January 8, 2013

First Posted (Estimated)

January 10, 2013

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 5, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHS-740

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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