Osteopathic Treatment for Low Back Pain

Overseen By Daniel Cawley, DC, MS, MSHS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edward Via Virginia College of Osteopathic Medicine

Must not be taking: Muscle relaxers

Disqualifiers: Spinal surgery, Radiculopathy, Cancer, Diabetes, others

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

Compensation: Varies

Number of Visits: 4

Duration: 5-7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a hands-on therapy called osteopathic manipulative treatment (OMT) can relieve chronic low back pain. It addresses both physical and mental health by assessing OMT's effects on muscles and daily activities. Individuals experiencing low back pain for over three months may qualify. Participants will attend four treatment sessions and report their feelings before and after to help researchers evaluate the treatment's impact. As an unphased trial, this study provides a unique opportunity to contribute to understanding a potentially beneficial therapy for chronic low back pain.

Will I have to stop taking my current medications?

If you are currently taking muscle relaxers, you will need to stop before joining this trial. The protocol does not specify about other medications, so it's best to discuss your specific situation with the trial coordinators.

What prior data suggests that osteopathic manipulative treatment is safe for low back pain?

Research has shown that osteopathic manipulative treatment (OMT) is generally safe. Studies have found that OMT effectively reduces low back pain without causing serious side effects. In trials involving individuals with low back pain, participants reported a significant decrease in pain, and no major safety issues were noted. Some individuals might experience mild discomfort during or after treatment, but these effects are usually temporary. Overall, OMT is considered a well-tolerated option for managing musculoskeletal issues like chronic low back pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Osteopathic Manipulative Treatment (OMT) for low back pain because it offers a hands-on approach that aims to improve body function through manual therapy. Unlike standard treatments such as pain medications, physical therapy, or surgery, OMT focuses on manipulating the muscles and joints to enhance the body's natural healing processes. This method potentially reduces the need for drugs and their associated side effects, providing a more holistic and non-invasive option for patients. Additionally, OMT may offer quicker relief by directly addressing musculoskeletal imbalances, which is an appealing alternative for those seeking immediate or complementary interventions.

What evidence suggests that osteopathic manipulative treatment might be an effective treatment for low back pain?

Research has shown that osteopathic manipulative treatment (OMT) can help with long-term low back pain. One study found that OMT reduced pain and improved patients' mobility. Another study demonstrated that OMT could lower pain and enhance overall well-being. However, some studies found no major benefits compared to placebo treatments. While results have varied, many studies suggest OMT might help some people with low back pain. Participants in this trial will receive OMT to further evaluate its effectiveness. ^{4 5 6 7 8}

Who Is on the Research Team?

Daniel Cawley, DC, MS, MSHS

Principal Investigator

VCOM

Are You a Good Fit for This Trial?

This trial is for adults with chronic lower back pain. Participants will receive osteopathic manipulative treatment to see if it helps with their condition. They should be able to attend four sessions over 5-7 weeks and complete surveys about their pain and well-being.

Inclusion Criteria

I am between 18 and 65 years old.

I have had chronic low back pain for more than 3 months.

Exclusion Criteria

I have received an injection for pain in the last month.

I have had surgery on my spine or pelvis.

I have a foot condition that affects how I walk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive four osteopathic manipulative treatment (OMT) sessions focusing on the myofascial system of the back, legs, and feet

5-7 weeks

4 visits (in-person)

Follow-up

Participants are monitored for changes in muscle stiffness, plantar pressure, and patient-reported outcomes on pain, disability, sleep quality, stress, anxiety, depression, pain catastrophizing, and pain self-efficacy

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Osteopathic Manipulative Treatment

Trial Overview The study tests whether osteopathic manipulative treatment (OMT) can improve muscle stiffness, walking pressure, and patient-reported outcomes like pain levels, disability, sleep quality, stress, anxiety, depression, and self-efficacy in managing pain.

How Is the Trial Designed?

Group I: OMT Treatment Group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Edward Via Virginia College of Osteopathic Medicine

Lead Sponsor

Trials

24

Recruited

2,700+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36732038/

Osteopathic manipulative treatment of patients with chronic ... Osteopathic manipulative treatment of patients with chronic low back pain in the United States: a retrospective cohort study · Abstract.

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2777527

Effect of Osteopathic Manipulative Treatment vs Sham ... In acute LBP, manipulative treatment modestly reduces pain and activity limitations up to 6 weeks. Whether these effects are explained by ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0965229920318835

Effectiveness of osteopathic interventions in chronic non ... Mandara, et al. A randomised controlled trial on the effectiveness of osteopathic manipulative treatment of chronic low back pain. Int. J. Osteopath. Med ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01765777

Efficacy of Osteopathic Manipulative Medicine (OMM) and ... The research has demonstrated separately that phototherapy and osteopathic manipulative medicine (OMM) are effective in reducing chronic low back pain.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/12838090/

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 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35414546/

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 ...

7. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/1471-2474-6-43

Osteopathic manipulative treatment for low back pain Efficacy of osteopathic manipulative treatment. The overall results clearly demonstrate a statistically significant reduction in low back pain ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1360859225000993

An overview of systematic reviews on the efficacy and ... Manipulative osteopathic techniques appears to be particularly effective in musculoskeletal conditions. Overall, the evidence base for the outcomes of manual ...