Recruiting

OMM & Phototherapy

Sponsor:

New York Institute of Technology

Code:

NCT01765777

Conditions

Chronic Lower Back Pain

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Osteopathic Manipulative Medicine

Phototherapy

Study Details

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.

Conditions

Chronic Lower Back Pain

Study ID

NCT01765777

Start date

Jun, 2011

Status verified date

Aug, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

experimental: Phototherapy Group

Subjects in this arm will receive a phototherapy intervention.

experimental: OMM and Phototherapy Group

Subjects in this arm will receive both the OMM and phototherapy interventions.

Interventions

Osteopathic Manipulative Medicine

Phototherapy

Primary outcome measure

  • 10 cm visual analog scale for quantitative back pain [ Time Frame: 8 weeks ]
  • SF-36 Health Survey to measure Quality of Life [ Time Frame: 8 weeks ]
  • The Oswestry Back Questionnaire to measure qualitative back pain [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Patricia S Kooyman, D.O.

516-686-1309pkooyman@nyit.edu

Peter Douris, PT,DPT, EdD

516-686-7688pdouris@nyit.edu

Locations

New York Institute of Technology

Recruiting

Old Westbury, New York, United States, 11568

Contacts

Hallie Zwibel, D.O

516-686-3771hzwibel@nyit.edu

Principal Investigator:

Patricia S Kooyman, D.O.

More Information

Sponsor

New York Institute of Technology

Last update posted

Aug 6, 2024

Last verified

Aug, 2024

Keywords

  • Low back pain
  • Lower back pain
  • Chronic back pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York Institute of Technology on 2024-08-06.