Osteopathic Treatment for Low Back Pain

Overseen By Nicole Fremarek, DO

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Edward Via Virginia College of Osteopathic Medicine

Must not be taking: Corticosteroids, Anticoagulants, Muscle relaxants

Disqualifiers: BMI > 30, Pregnancy, Spinal surgery, others

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

Compensation: Varies

Number of Visits: 10

Duration: 6 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatments for chronic low back pain (CLBP) linked to the thoracolumbar fascia, a connective tissue in the lower back. One treatment uses ultrasound-guided hydrodissection to create space in the tissue, while the other involves osteopathic manipulative treatment (OMT), which uses hands-on techniques to relieve pain. The trial evaluates the effectiveness of these treatments by analyzing ultrasound images with machine learning tools. Suitable candidates for this trial are those who have experienced CLBP for more than three months and have pain related to the thoracolumbar fascia. As an unphased trial, this study offers a unique opportunity to explore innovative treatments for CLBP and contribute to advancing medical knowledge.

Will I have to stop taking my current medications?

Yes, you may need to stop certain medications. If you are using corticosteroids or medications like anticoagulants and muscle relaxants, you must be able to stop them during the study.

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

Studies have shown that Osteopathic Manipulative Treatment (OMT) is safe and effective for reducing low back pain. Research indicates that patients experienced less pain and improved mobility after OMT sessions. Side effects are usually mild, such as temporary soreness.

Ultrasound-guided hydrodissection is also under exploration for back pain relief. Studies suggest this treatment can effectively ease pain and enhance movement by injecting fluid to separate tissue layers. Reported side effects are minimal, often just minor discomfort at the injection site.

Previous research has demonstrated that both treatments are well-tolerated, making them promising options for those considering clinical trials for back pain relief. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for chronic low back pain because they offer innovative approaches compared to typical options like pain medications, physical therapy, or surgery. The Osteopathic Manipulative Treatment (OMT) leverages hands-on techniques to address somatic dysfunction by using a variety of manipulative methods, including High Velocity, Low Amplitude (HVLA) and myofascial release. This could provide a non-pharmacological option that actively engages the body's natural healing processes. Meanwhile, the Ultrasound Guided Hydrodissection targets the thoracolumbar fascia using a fluid wave to separate tissue planes, which could offer a more precise and less invasive method for reducing fascial restrictions than traditional mechanical debridement. These methods could potentially provide faster and more sustainable pain relief without the side effects associated with systemic medications.

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

This trial will compare two treatments for chronic low back pain. Studies have shown that ultrasound-guided hydrodissection, one of the treatments in this trial, can help treat chronic low back pain. This method uses fluid to gently separate tissue layers, relieving pain and improving lower back function. For Osteopathic Manipulative Treatment (OMT), another treatment option in this trial, evidence suggests it can also reduce pain and improve movement in people with chronic low back pain. OMT involves hands-on techniques to treat and prevent pain. Both treatments offer promising ways to manage low back pain by focusing on specific tissue issues. ^{4 5 6 7 8}

Who Is on the Research Team?

Gunnar Brolinson DO, FAOASM

Principal Investigator

Edward Via Colege of Osteopathic Medicine

Albert J Kozar DO, FAOASM, R-MSK

Principal Investigator

Edward Via College of Osteopathic Medicine

Are You a Good Fit for This Trial?

This trial is for individuals with low back pain, specifically those who have chronic lower back pain (CLBP) and are interested in exploring new treatment options. Participants will be chosen based on physical exams and ultrasound imaging that suggest their pain may be related to the thoracolumbar fascia (TLF).

Exclusion Criteria

I have had physical therapy, acupuncture, or similar treatments in the last 3 months.

Pregnancy or Breastfeeding: current or remote, within the past 6 months

Allergy to ultrasound gel - relative, consider alternatives

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Subjects complete standardized pain-related questionnaires and undergo baseline ultrasound imaging and functional assessments.

1 week

1 visit (in-person)

Treatment

Participants with CLBP undergo 3 treatment sessions of either ultrasound-guided hydrodissection or Osteopathic Manipulative Treatment (OMT) at 2-3 week intervals.

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with repeat assessments at 2, 4, 6, 12, and 24 weeks post-treatment.

24 weeks

5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Osteopathic Manipulative Treatment (OMT)
• Ultrasound Guided Hydrodissection of the Thoracolumbar Fascia

Trial Overview The study tests two treatments: Ultrasound Guided Hydrodissection of the TLF and Osteopathic Manipulative Treatment (OMT). It aims to develop machine learning tools to analyze ultrasound images for better diagnosis and treatment assessment.

How Is the Trial Designed?

Group I: Ultrasound Guided Hydrodissection of TLF Glide Impairment Experimental Treatment 1 Intervention

CLBP Subjects with documented TLF glide impairment will undergo a series of 3 ultrasound-guided hydrodissection treatments of the TLF at 2-3 locations bilaterally, covering T11-S2, using D5w (132 cc total) and 22g 4" needle at 2-3 week intervals, using direct ultrasound guidance using a high frequency probe. Fluid pressure dissection/debridement (a fluid wave) is utilized to create tissue plane separation as opposed to needle mechanical debridement.

Group II: Osteopathic Manipulative Treatment (OMT) Experimental Treatment 1 Intervention

CLBP Subjects with documented TLF glide impairment will undergo a screening structural examination for somatic dysfunction and then be treated by OMT as based on clinical experience using a principle based protocol. A series of 3 OMT treatment sessions spaced at 2-week intervals. The same procedures will be used in this study as we use in our daily clinical practice. This is a pilot treatment arm, no sham or direct blinding will be utilized. Subjects will be screening using the Area of Greatest Restriction (AGR) protocol as taught by Ed Stiles DO (Textbook of Osteopathic Medicine Ch. 24 by Stiles pp. 265-266). After treating 2-3 areas by this method, the examiner will also screen the Lumbar, Sacrum \& Pelvis by standard Osteopathic Structural Evaluation (standing \& supine/prone). An additional 1-2 areas may be treated. Treatments may include High Velocity, Low Amplitude (HVLA), Low Velocity, High Amplitude, soft tissue, myofascial release and muscle energy manipulation techniques.

Who Is Running the Clinical Trial?

Edward Via Virginia College of Osteopathic Medicine

Lead Sponsor

Trials

24

Recruited

2,700+

Virginia Polytechnic Institute and State University

Collaborator

Trials

162

Recruited

26,900+

Published Research Related to This Trial

Osteopathic manipulative treatment (OMT) is effective for managing musculoskeletal conditions, especially low back pain, and is recommended as a first-line noninvasive therapy after self-care, according to national guidelines.

While adverse effects from OMT are rare, they can include serious conditions like cauda equina syndrome and lumbar disk herniation, highlighting the importance of considering contraindications related to bleeding risks and joint integrity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Musculoskeletal Therapies: Osteopathic Manipulative Treatment. Jonas, C.[2018]

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]

Osteopathic manual treatment (OMT) significantly improved chronic low back pain in patients, with 30% and 50% pain reductions observed at week 12, meeting the criteria for a medium effect size according to the Cochrane Back Review Group.

OMT was found to be safe and well-accepted by patients, leading to less frequent use of prescription pain medications compared to sham treatment, while ultrasound therapy (UST) showed no efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteopathic manual treatment and ultrasound therapy for chronic low back pain: a randomized controlled trial. Licciardone, JC., Minotti, DE., Gatchel, RJ., et al.[2022]

Osteopathic manual treatment (OMT) significantly improved chronic low back pain (LBP) in patients with high baseline pain severity, showing a large effect size (RR, 2.04; P<0.001) and substantial pain reduction after six sessions over eight weeks.

Patients with high baseline pain severity also experienced clinically important improvements in back-specific functioning, suggesting that OMT could be a beneficial non-invasive treatment option before considering more invasive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of osteopathic manual treatment for chronic low back pain according to baseline pain severity: results from the OSTEOPATHIC Trial. Licciardone, JC., Kearns, CM., Minotti, DE.[2021]

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 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]

Osteopathic manipulative treatment (OMT) is effective and safe for managing back and pelvic pain in pregnant women, addressing common issues like ligament and joint impairments.

The review analyzed literature from MEDLINE and the Cochrane Library, confirming the efficacy of OMT procedures specifically for lumbosacral pain during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of osteopathic manipulative technique in the treatment of back pain during pregnancy. Majchrzycki, M., Wolski, H., Seremak-Mrozikiewicz, A., et al.[2019]

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]

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]

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 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]

Citations

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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 ...

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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 ...

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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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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 ...

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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 ...