OMM + Phototherapy for Lower Back Pain

Overseen By Christine Flynn, PT, DPT, NCS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New York Institute of Technology

Disqualifiers: Ankylosing spondylitis, Cancer, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is Osteopathic Manipulative Treatment (OMT) generally safe for humans?

Research on Osteopathic Manipulative Treatment (OMT) suggests that while adverse events (unwanted effects) can occur, they are not well-defined in terms of how often they happen or how severe they are. There is no clear benchmark for safety, but studies have been conducted to better understand potential risks. ^{1 2 3 4 5}

How is the OMM + Phototherapy treatment different from other treatments for lower back pain?

OMM (Osteopathic Manipulative Medicine) is unique because it involves hands-on techniques to improve body function and support balance, while phototherapy uses light to potentially reduce pain and inflammation. This combination offers a novel approach by integrating manual therapy with light therapy, which is not commonly used together in standard treatments for lower back pain. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment OMM + Phototherapy for Lower Back Pain?

Research shows that osteopathic manipulative treatment (OMT) can significantly improve pain intensity and reduce the need for pain medication in patients with chronic low back pain. This suggests that OMT, a key component of the treatment, is effective for managing low back pain. ^{3 6 7 9 11}

Who Is on the Research Team?

Patricia S Kooyman, D.O.

Principal Investigator

New York Institute of Technology

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had lower back pain for at least 3 months.

Exclusion Criteria

You have received worker's compensation or are involved in a legal case related to lower back issues in the past three months.

People who are sensitive to light.

I had lower back surgery in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either OMM, phototherapy, or a combination of both for chronic lower back pain

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Osteopathic Manipulative Medicine
• Phototherapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Phototherapy Group Experimental Treatment 1 Intervention

Subjects in this arm will receive a phototherapy intervention.

Group II: Osteopathic Manipulative Medicine Group Experimental Treatment 1 Intervention

Subjects in this arm will receive an OMM intervention.

Group III: OMM and Phototherapy Group Experimental Treatment 2 Interventions

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

Group IV: Control Group Active Control 1 Intervention

Subjects in this arm continue with standard medical care

Osteopathic Manipulative Medicine is already approved in United States for the following indications:

Approved in United States as Osteopathic Manipulative Medicine for:

• Chronic Lower Back Pain
• Musculoskeletal Causes of Back Pain

Who Is Running the Clinical Trial?

New York Institute of Technology

Lead Sponsor

Trials

56

Recruited

2,300+

Published Research Related to This Trial

In a study of 445 adults with chronic low back pain, those treated by osteopathic physicians (DOs) who used osteopathic manipulative treatment (OMT) reported significantly lower pain intensity and disability compared to those treated by allopathic physicians (MDs).

Patients receiving OMT also had a reduced need for pain medications, including nonsteroidal anti-inflammatory drugs and opioids, indicating that OMT may be an effective and safer treatment option for managing chronic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteopathic Medical Care With and Without Osteopathic Manipulative Treatment in Patients With Chronic Low Back Pain: A Pain Registry-Based Study. Licciardone, JC., Gatchel, RJ.[2022]

Spinal manipulation, including osteopathic manipulative treatment (OMT), is recommended for patients with acute low back pain without radiculopathy, particularly when initiated within the first month of symptoms.

The author reviews three major clinical trials of OMT for low back pain in the U.S., highlighting its potential effectiveness for both acute and chronic cases, which supports its role in osteopathic medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The unique role of osteopathic physicians in treating patients with low back pain. Licciardone, JC.[2006]

Between 2000 and 2019, the utilization of osteopathic manipulative treatment (OMT) among Medicare beneficiaries decreased by 24.5%, indicating a decline in this noninvasive treatment option despite its established benefits.

The decrease in OMT usage is likely linked to lower reimbursement rates for OMT services, which may have disincentivized physicians, alongside a reduction in residency programs offering OMT training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization and reimbursement trends of osteopathic manipulative treatment for Medicare patients: 2000-2019. Starr, EG., Smith, JF., Hanson, RB., et al.[2023]

In a study involving 400 participants with nonspecific low back pain, standard osteopathic manipulative treatment (OMT) showed a statistically significant but small reduction in activity limitations compared to sham OMT at 3 months, with a mean difference of -3.4 points on the Quebec Back Pain Disability Index.

Despite the small effect size, the clinical relevance of the improvement is uncertain, and both treatment groups reported similar rates of serious adverse events, indicating that OMT is generally safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Osteopathic Manipulative Treatment vs Sham Treatment on Activity Limitations in Patients With Nonspecific Subacute and Chronic Low Back Pain: A Randomized Clinical Trial. Nguyen, C., Boutron, I., Zegarra-Parodi, R., et al.[2022]

Osteopathic manipulative treatment (OMT) shows promising effectiveness in reducing pain and improving function for conditions like acute and chronic non-specific low back pain, chronic non-specific neck pain, and chronic non-cancer pain, based on a review of nine systematic reviews and meta-analyses involving 3740 participants.

There is limited and inconclusive evidence regarding the efficacy of OMT for pediatric conditions, primary headaches, and irritable bowel syndrome, and no adverse events were reported in most studies, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of osteopathic manipulative treatment: an overview of systematic reviews. Bagagiolo, D., Rosa, D., Borrelli, F.[2022]

In a study involving 884 patients, the incidence of adverse events immediately after osteopathic manipulative treatment (OMT) was found to be low at 2.5%, with pain or discomfort being the most common complaint.

Women reported experiencing adverse events more frequently than men, suggesting a potential demographic factor in the response to OMT, but overall, the rate of adverse events was lower than those reported in other manual therapy practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Adverse Events Reported Immediately After Osteopathic Manipulative Treatment. Degenhardt, BF., Johnson, JC., Brooks, WJ., et al.[2022]

Osteopathic medicine, which has been around for over 130 years, is often misunderstood by healthcare professionals, highlighting the need for better education about the differences and similarities between osteopathic (DO) and allopathic (MD) physicians.

Osteopathic manipulative treatment (OMT) is a key aspect of osteopathic medicine, and while it has been researched for its effects on various conditions, including musculoskeletal and respiratory issues, challenges remain in conducting clinical research on its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An introduction to clinical research in osteopathic medicine. Earley, BE., Luce, H.[2011]

A systematic review of 23 studies found that the majority of adverse events (AEs) following osteopathic manipulative treatment (OMT) were mild, accounting for 98% of reported AEs, indicating a generally safe profile for this treatment.

The study established a patient safety benchmark for post-OMT AEs at 1.0 AEs per 100 post-OMT interval-days, providing a reference point for future research and comparisons in patient safety within osteopathic manipulative medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining the landscape of patient harm after osteopathic manipulative treatment: synthesis of an adverse event model. Unger, MD., Barr, JN., Brower, JA., et al.[2023]

A review of medical records from 346 pediatric patients receiving osteopathic manipulative treatment (OMT) found no serious complications, indicating that OMT is a safe treatment option for children.

While 9% of patients experienced minor treatment-associated aggravations (worsening of symptoms), there were no significant differences in outcomes based on gender, suggesting that OMT can be safely administered by trained physicians in the pediatric population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of iatrogenesis associated with osteopathic manipulative treatment of pediatric patients. Hayes, NM., Bezilla, TA.[2006]

Osteopathic manipulative treatment (OMT) significantly reduces pain and improves functional status in patients with nonspecific acute and chronic low back pain (LBP), with moderate-quality evidence showing a mean difference in pain relief of -12.91 and a standard mean difference of -0.36 for functional status.

OMT is particularly effective for pregnant and postpartum women, with low-quality evidence indicating a mean difference in pain relief of -23.01 during pregnancy and a mean difference of -41.85 postpartum, suggesting that OMT provides substantial benefits beyond placebo effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

American Osteopathic Association Guidelines for Osteopathic Manipulative Treatment (OMT) for Patients With Low Back Pain. [2017]

In a study of 455 patients with chronic low back pain, osteopathic manipulative treatment (OMT) showed medium treatment effects overall, with a significant reduction in pain intensity for those with higher baseline pain scores (VAS ≥ 35 mm).

Patients with greater baseline disability (RMDQ scores of 16 or more) experienced large and significant improvements in back-specific functioning, suggesting that OMT can effectively target specific subgroups of patients to reduce reliance on more invasive treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting Patient Subgroups With Chronic Low Back Pain for Osteopathic Manipulative Treatment: Responder Analyses From a Randomized Controlled Trial. Licciardone, JC., Gatchel, RJ., Aryal, S.[2017]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Osteopathic Medical Care With and Without Osteopathic Manipulative Treatment in Patients With Chronic Low Back Pain: A Pain Registry-Based Study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The unique role of osteopathic physicians in treating patients with low back pain. [2006]

3. Germany pubmed.ncbi.nlm.nih.gov

Utilization and reimbursement trends of osteopathic manipulative treatment for Medicare patients: 2000-2019. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of Osteopathic Manipulative Treatment vs Sham Treatment on Activity Limitations in Patients With Nonspecific Subacute and Chronic Low Back Pain: A Randomized Clinical Trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of osteopathic manipulative treatment: an overview of systematic reviews. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Characterizing Adverse Events Reported Immediately After Osteopathic Manipulative Treatment. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

An introduction to clinical research in osteopathic medicine. [2011]

8. England pubmed.ncbi.nlm.nih.gov

Defining the landscape of patient harm after osteopathic manipulative treatment: synthesis of an adverse event model. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Incidence of iatrogenesis associated with osteopathic manipulative treatment of pediatric patients. [2006]

10. United States pubmed.ncbi.nlm.nih.gov

American Osteopathic Association Guidelines for Osteopathic Manipulative Treatment (OMT) for Patients With Low Back Pain. [2017]

11. United States pubmed.ncbi.nlm.nih.gov

Targeting Patient Subgroups With Chronic Low Back Pain for Osteopathic Manipulative Treatment: Responder Analyses From a Randomized Controlled Trial. [2017]