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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNew York Institute of Technology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age range: 18 - 65 years old

Subjects with constant or intermittent nonspecific lower back pain for a minimum of three (3) months duration.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Osteopathic Manipulative Medicine

    Procedure/Surgery
  • Phototherapy

    Procedure/Surgery

Treatment groups

48 Participants
are divided into 4 treatment groups
Group A: Control GroupNo intervention 0 interventions
Group B: Osteopathic Manipulative Medicine GroupExperimental treatment 1 intervention
Group C: Phototherapy GroupExperimental treatment 1 intervention
Group D: OMM and Phototherapy GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

10 cm visual analog scale for quantitative back pain

VAS Data collected at all visits

Time frame
8 weeks
2

SF-36 Health Survey to measure Quality of Life

SF-36 survey data collected at 3 points

Time frame
8 weeks
3

The Oswestry Back Questionnaire to measure qualitative back pain

Oswestry questionnaire data collected at 3 points

Time frame
8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.