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OMM + Phototherapy for Lower Back Pain

N/A
Recruiting
Led By Patricia S Kooyman, D.O.
Research Sponsored by New York Institute of Technology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age range: 18 - 65 years old
Be older than 18 years old
Must not have
Prospective subjects who have undergone surgery of the lower back in the preceding three (3) months
Prospective subjects who have received spinal manipulation in the previous three (3) months, or on greater than three (3) occasions in the preceding year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is investigating whether a combination of osteopathic manipulative medicine and phototherapy provides greater pain relief for chronic lower back pain than standard medical management or either treatment alone.

Who is the study for?
This trial is for adults aged 18-65 with chronic lower back pain lasting at least three months. It's not suitable for those with certain back conditions like ankylosing spondylitis, herniated discs, or recent surgery. Pregnant individuals, those who've had recent back treatments or litigation related to back issues are also excluded.
What is being tested?
The study tests if combining Osteopathic Manipulative Medicine (OMM) and Phototherapy provides better pain relief for chronic lower back pain compared to standard care or either treatment alone. Participants will receive one of these approaches to see which is more effective.
What are the potential side effects?
Potential side effects from OMM may include temporary soreness or discomfort in the treated area. Phototherapy could cause skin reactions such as redness or irritation, especially in people with photosensitivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I had lower back surgery in the last 3 months.
Select...
I have not had spinal manipulation more than 3 times in the last year or in the past 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
10 cm visual analog scale for quantitative back pain
SF-36 Health Survey to measure Quality of Life
The Oswestry Back Questionnaire to measure qualitative back pain

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Phototherapy GroupExperimental Treatment1 Intervention
Subjects in this arm will receive a phototherapy intervention.
Group II: Osteopathic Manipulative Medicine GroupExperimental Treatment1 Intervention
Subjects in this arm will receive an OMM intervention.
Group III: OMM and Phototherapy GroupExperimental Treatment2 Interventions
Subjects in this arm will receive both the OMM and phototherapy interventions.
Group IV: Control GroupActive Control1 Intervention
Subjects in this arm continue with standard medical care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osteopathic Manipulative Medicine
2006
Completed Phase 3
~340
Phototherapy
2021
Completed Phase 4
~750

Find a Location

Who is running the clinical trial?

New York Institute of TechnologyLead Sponsor
54 Previous Clinical Trials
2,158 Total Patients Enrolled
Patricia S Kooyman, D.O.Principal InvestigatorNew York Institute of Technology

Media Library

Osteopathic Manipulative Medicine Clinical Trial Eligibility Overview. Trial Name: NCT01765777 — N/A
Chronic Lower Back Pain Research Study Groups: OMM and Phototherapy Group, Control Group, Osteopathic Manipulative Medicine Group, Phototherapy Group
Chronic Lower Back Pain Clinical Trial 2023: Osteopathic Manipulative Medicine Highlights & Side Effects. Trial Name: NCT01765777 — N/A
Osteopathic Manipulative Medicine 2023 Treatment Timeline for Medical Study. Trial Name: NCT01765777 — N/A
~3 spots leftby Dec 2025
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