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?

This trial aims to determine if combining osteopathic manipulative medicine (hands-on techniques to relieve pain) with phototherapy (light treatment) provides better relief for chronic lower back pain than standard care or each treatment alone. Participants will be divided into groups to receive either both treatments, just one, or continue with their usual medical care. It suits individuals who have experienced lower back pain intermittently for at least three months and do not have specific conditions like a herniated disc or recent back surgery. As an unphased trial, this study offers a unique opportunity to explore innovative treatment combinations for chronic pain relief.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Osteopathic Manipulative Medicine (OMM) is safe for patients. Studies indicate that OMM is generally well-tolerated, with very few side effects reported.

For phototherapy, research has found it to be safe when used properly. Phototherapy uses light to relieve pain and is non-invasive, meaning it doesn't involve surgery or entering the body. It is considered a safe option for pain relief, with minimal side effects.

Both treatments have been used for various conditions, and research supports their safety. For those considering joining a clinical trial, these findings suggest that both OMM and phototherapy have a good safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Osteopathic Manipulative Medicine (OMM) and phototherapy for lower back pain because these treatments offer unique approaches compared to standard care options like pain medications or physical therapy. OMM involves hands-on techniques to improve body mechanics, potentially reducing pain and enhancing mobility without drugs. Phototherapy uses specific light wavelengths to reduce inflammation and promote healing at the cellular level. Unlike typical painkillers or surgeries, these approaches have the potential to address pain through natural, non-invasive methods, minimizing side effects and offering new hope for patients seeking alternative therapies.

What evidence suggests that this trial's treatments could be effective for chronic lower back pain?

Research shows that phototherapy, which uses special types of light, can effectively relieve chronic pain, including lower back pain. Studies have found that low-level laser therapy reduces pain without drugs or side effects. In this trial, some participants will receive only phototherapy. Others will receive osteopathic manipulative medicine (OMM), which uses hands-on techniques to treat pain and improve body function. Some research suggests that OMM might help with back pain, but its benefits compared to fake treatments (like pretend manipulation) are not always clear. Additionally, a group in this trial will receive both OMM and phototherapy, potentially offering better pain relief for chronic lower back pain by targeting different pain pathways in the body. ^{2 6 7 8 9}

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

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]

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) 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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

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Osteopathic manipulative treatment for chronic low back pain There were no significant benefits with osteopathic manipulative treatment, as compared with sham manipulation. Conclusions: Osteopathic manipulative treatment ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01765777

Efficacy of Osteopathic Manipulative Medicine (OMM) and ... The American Osteopathic Association (AOA) published in 2009 the "Guidelines for Osteopathic Manipulative Treatment (OMT) for Patients with Low Back Pain." ...

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Effect of Osteopathic Manipulative Treatment vs Sham ... Question What is the effectiveness of osteopathic manipulative treatment (OMT) compared with sham OMT in reducing low back pain ...

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Effect of osteopathic manipulative treatment on pain, ... Osteopathic manipulative treatment (OMT) proposes a global manual intervention in chronic pain. ... Borges et al. Effects of spinal manipulation and ...

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Osteopathic manipulative treatment for low back pain Osteopathic manipulative treatment (OMT) is a distinctive modality commonly used by osteopathic physicians to complement their conventional ...

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Efficacy and safety of osteopathic manipulative treatment Objective: To summarise the available clinical evidence on the efficacy and safety of osteopathic manipulative treatment (OMT) for different ...

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Osteopathic manipulative treatment for low back pain OMT denotes osteopathic manipulative treatment. *A total of 30 subjects with menopausal symptoms were randomized; however, only 12 subjects had ...

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An overview of systematic reviews on the efficacy and ... Specifically, the following manual treatment methods were considered: osteopathic manipulative treatment (OMT), spinal manipulative therapy (SMT), myofascial ...

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The Safety of Osteopathic Manipulative Treatment (OMT) PDF | On Mar 1, 2018, Michael A. Seffinger published The Safety of Osteopathic Manipulative Treatment (OMT) | Find, read and cite all the research you need ...