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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

New York Institute of TechnologyLead Sponsor

51 Previous Clinical Trials

2,023 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I be included in this experimental endeavor?

"This research project seeks 48 people suffering from back pain, aged 18 and 65. Prerequisites for enrolment include a minimum of three months' experience with constant or intermittent lower back discomfort as well as being within the specified age range."

Answered by AI

Does eligibility for this trial extend to those under the age of 45?

"The parameters to join this medical experiment indicate 18-65 years old as eligible candidates. There are 11 trials catered towards minors and 264 targeting seniors."

Answered by AI

Are enrolment opportunities still available for the trial?

"Data hosted on clinicaltrials.gov demonstrates that participant recruitment for this trial is currently ongoing, with the first posting of the study occurring on June 1, 2011 and its most recent update taking place April 4th 2022."

Answered by AI

How many participants can the study accommodate at its peak capacity?

"Indeed, the trial's listing on clinicaltrials.gov confirms that this medical experiment is still looking for volunteers to take part in it. The original posting date was June 1st 2011 and was recently updated on April 4th 2022. This study requires 48 participants from one location."

Answered by AI

Recent research and studies

PainJournal

The Relationship Between Paraspinal EMG and Chronic Low Back Pain

Nouwen, Arie, and Clarissa Bush. 1984. “The Relationship Between Paraspinal EMG and Chronic Low Back Pain”. Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/0304-3959(84)90093-9.

Experimental NeurologyJournal

The Ability of Developing Spinal Neurons to Reinnervate a Muscle Through a Peripheral Nerve Conduit Is Enhanced by Cografted Embryonic Spinal Cord

Sieradzan, Katarzyna, and Gerta Vrbová. 1993. “The Ability of Developing Spinal Neurons to Reinnervate a Muscle Through a Peripheral Nerve Conduit Is Enhanced by Cografted Embryonic Spinal Cord”. Experimental Neurology. Elsevier BV. doi:10.1006/exnr.1993.1123.

SpineJournal

Osteopathic Manipulative Treatment for Chronic Low Back Pain

Licciardone, John C., Scott T. Stoll, Kimberly G. Fulda, David P. Russo, Jeff Siu, William Winn, and Jon Swift Jr,. 2003. “Osteopathic Manipulative Treatment for Chronic Low Back Pain”. Spine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.brs.0000067110.61471.7d.

Lasers in Surgery and MedicineJournal