Osteopathic Manipulative Treatment for Lower Back Pain

Overseen By Unknown

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edward Hines Jr. VA Hospital

Disqualifiers: Serious pathology, Neurological diseases, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding Osteopathic Manipulative Therapy (OMT) to usual care at the VA can improve outcomes for people with chronic low back pain. OMT involves a doctor using hands-on techniques like stretching and gentle pressure to move muscles and joints. Individuals with low back pain for more than three months, who frequently experience pain, and seek care from a participating VA clinic might be suitable candidates. Participants will receive either their usual VA care or usual care plus OMT to determine which approach is more effective. As an unphased trial, this study provides patients the chance to explore innovative treatment options that may enhance their quality of life.

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 focuses on adding Osteopathic Manipulative Therapy to usual care, so it's best to discuss your medications with the trial team.

What prior data suggests that Osteopathic Manipulative Treatment is safe for individuals with chronic low back pain?

Research has shown that Osteopathic Manipulative Treatment (OMT) is generally safe for individuals with long-term low back pain. Studies have found that OMT effectively reduces pain without major side effects. For instance, one study reported a clear decrease in low back pain after OMT, indicating it is well-tolerated. Another study noted that OMT slightly reduces pain and activity limitations, supporting its safe use. Overall, this evidence suggests that OMT is a safe treatment option for those with 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 lower back pain because it offers a hands-on approach that differs from standard therapies like medication and physical therapy. OMT involves a physician using techniques such as stretching, applying gentle pressure, and resistance to move muscles and joints, which could potentially address pain more directly by improving body mechanics and circulation. This method may provide relief by enhancing the body's natural healing processes, offering an alternative for those seeking non-drug solutions to manage their back pain.

What evidence suggests that Osteopathic Manipulative Treatment is effective for chronic low back pain?

This trial will compare Osteopathic Manipulative Treatment (OMT) combined with usual VA care to usual VA care alone for chronic low back pain. Studies have shown mixed results for OMT. Some research has found that OMT can reduce pain and improve mobility, offering relief for those with this condition. However, other studies did not find significant benefits compared to placebo treatments. Despite these mixed findings, some individuals report feeling better after OMT. The treatment involves a doctor using hands-on techniques to move muscles and joints, which might help ease discomfort. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with chronic low back pain who receive their usual medical care at the VA. Participants should be willing to undergo additional Osteopathic Manipulative Therapy (OMT), which involves hands-on techniques by a doctor.

Inclusion Criteria

Seeking care for LBP from a participating VA clinic

Able to follow study protocol

I am 18 years old or older.

Exclusion Criteria

My lower back pain is due to a serious health issue.

I have a chronic illness or inflammation.

I have a neurological condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Osteopathic Manipulative Therapy (OMT) in addition to usual VA care for chronic low back pain

24 weeks

Regular visits as per usual VA care schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Osteopathic Manipulative Treatment

Trial Overview The study is testing if adding Osteopathic Manipulative Therapy, involving stretching and gentle pressure applied to muscles and joints, to standard VA care can better improve outcomes for those with chronic low back pain.

How Is the Trial Designed?

Group I: Usual VA Care + OMT Group Experimental Treatment 2 Interventions

Participants in this group will receive your usual VA care plus OMT. The addition of OMT is the research portion of the treatment. During the physician prescribed usual care visits, participants will receive the OMT treatment. During OMT (the research portion), a physician may move participants muscles and joints using hands-on techniques including stretching, gentle pressure and resistance, as well as applying forces to specific areas of the body. While receiving OMT, participants may be asked to change positions such as standing, sitting, or lying on your back, stomach or side. This treatment will be provided by the VA physicians involved in this study.

Group II: Usual VA Care Group Active Control 1 Intervention

All study participants will receive usual VA care that will be provided by a physiatrist at the Hines VA. After taking their medical history, they will perform a physical exam to assess their conditions. Based on the physical exam, the physicians may recommend more testing and/or treatment procedures.

Who Is Running the Clinical Trial?

Edward Hines Jr. VA Hospital

Lead Sponsor

Trials

18

Recruited

2,800+

Michigan State University

Collaborator

Trials

202

Recruited

687,000+

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. 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.

4. 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 ...

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2386783/

OSTEOPAThic Health outcomes In Chronic low back pain It will provide long awaited data on the efficacy of OMT and UPT for chronic low back pain. ... Osteopathic manipulative treatment for chronic low back pain: a ...

7. 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 ...

8. 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 ...