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

Trial Summary

What is the purpose of this trial?

This Study is for our continued study of the Thoracolumbar Fascia (TFL) in patients with and without low back pain by our experienced multidisciplinary team: Vincent Wang PhD, VT Biomedical Engineering \& Mechanics (BEAM). Albert J Kozar DO, FAOASM, R-MSK. P. Gunnar Brolinson, DO, FAOASM, FAOCFP. David T. Redden PhD, VCOM Research Biostatistician. Matthew Chung DO, VCOM and Team Physician at Virginia Tech. Edward Magalhaes, PhD, LPC, Psychiatry and Neuro- Behavioral Sciences, VCOM. This listing is specifically for our renewed efforts via two, Department of Defense (DoD) and American Osteopathic Association (AOA), extramurally, simultaneously funded grants for similar but distinct projects. Both funding sources are aware of each other's funding and have approved their grant study moving forward simultaneously with some integration. DoD: Machine Learning Analysis of Ultrasound Images for the Investigation of Thoracolumbar Myofascial Pain and Therapeutic Efficacy of Hydrodissection. The primary objectives of the proposed project are to: 1. develop reliable, quantitative image analysis approaches to objectively distinguish images from subjects with acute or chronic TLF pain from those without pain and 2. to assess the preliminary clinical efficacy of hydrodissection of the TLF as a novel therapeutic treatment for chronic LBP. AOA: Assessment of the Therapeutic Efficacy of OMT on Chronic Low Back Pain: An Integrated Sonographic and Machine Learning Analysis of Thoracolumbar Fascia Glide Impairment. The primary objectives of the proposed project are to: 1. assess the preliminary clinical efficacy of OMT as a therapeutic treatment for CLBP of TLF origin and 2. develop reliable, quantitative image analysis approaches to objectively distinguish images from subjects with TLF pain from those without pain. These projects will share 50 no LBP subjects as controls. The DOD study will include 50 acute LBP and 50 CLBP. The AOA study will include 50 CLBP. This project uses standard surveys, physical exam, functional tests, and ultrasound imaging to obtain both static images of the TLF at multiple transition zones. It further uses ultrasound to evaluate the dynamic gliding motion, via cine loops, of this fascia in 2 different body movements in subjects with acute low back pain (ALBP), with chronic low back pain (CLBP), and without low back pain (WLBP). All images will be clinically analyzed and further assessed by textural and machine learning analysis. Patients with CLBP (only) will choose to enter one of the two studies (DoD vs AOA) at the time of consent. All images will be clinically analyzed and further assessed by textural and machine learning analysis. Patients with CLBP (only) that are found to have TLF glide impairment or positive physical exam maneuvers suggesting TLF as etiology will enter the treatment arm of the chosen study at the time of consent, either ultrasound guided hydrodissection (USGH), or Osteopathic Manipulative Therapy (OMT). After receiving 3 treatments utilizing one of these modalities, the CLBP participants will have repeat standard surveys, physical exam, functional tests, and ultrasound imaging assessments at 2,4,6,12, and 24 weeks post-treatment. At the conclusion of this project, the investigators expect to have developed, refined, and implemented robust and feasible experimental and computational approaches which can be further expanded in larger-scale studies. The development of our data-driven computer models for the objective analysis of sonographic images of the TLF has high potential impact as it seeks to transform the assessment of TLF integrity, injury and healing via establishment of reliable US imaging biomarkers. The investigators anticipate that the tools developed will have broad utility to assess a variety of clinical treatments for the TLF. The investigators also hope to validate physical exam maneuvers that may predict TLF mediated LBP and have preliminary evidence of the efficacy of hydrodissection and OMT in TLF mediated LBP. In pursuit of these objectives, the investigators will adopt an innovative approach featuring a robust integration of clinical imaging, physical exam, pain and functional outcomes, quantitative image analysis, and machine learning analyses. Specific Aim 1: Compare sonographic TLF imaging characteristics in individuals with acute versus chronic pain to those without low back pain. Specific Aim 2: Develop a machine learning (ML) classification algorithm to reliably distinguish abnormal myofascial tissue in acute versus chronic pain stages from healthy tissue. Specific Aim 3: DoD Study: Assess the preliminary therapeutic efficacy of hydrodissection as a novel treatment for TLF pain using quantitative US imaging and ML tools. AOA Study: Assess the preliminary therapeutic efficacy of OMT as a treatment for CLBP using quantitative US imaging and ML tools.

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.

What data supports the effectiveness of the treatment Osteopathic Manipulative Treatment (OMT) and Ultrasound Guided Hydrodissection for low back pain?

Research shows that Osteopathic Manipulative Treatment (OMT) can significantly improve pain intensity and reduce the need for pain medication in people with chronic low back pain. Additionally, OMT has been found to help with activity limitations in patients with nonspecific subacute and chronic low back pain. ^{1 2 3 4 5}

Is osteopathic treatment for low back pain safe?

Osteopathic manipulative treatment (OMT) is generally considered safe, with rare adverse effects such as nerve damage, disk herniation, fractures, or bleeding issues. It is recommended as a first-line noninvasive therapy for low back pain, and is covered by many health insurance plans. ^{3 6 7 8 9}

How is the treatment for low back pain using Osteopathic Manipulative Treatment (OMT) and Ultrasound Guided Hydrodissection unique?

This treatment is unique because it combines Osteopathic Manipulative Treatment (OMT), which uses hands-on techniques to improve body function, with Ultrasound Guided Hydrodissection, a procedure that uses fluid to separate tissues and relieve pain. This combination targets both the structural and functional aspects of low back pain, offering a comprehensive approach that differs from standard treatments. ^{2 3 4 10 11}

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

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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 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]

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 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]

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]

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]

References

1. Scotland 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. [2021]

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

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

3. 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]

4. 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]

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

Osteopathic manual treatment and ultrasound therapy for chronic low back pain: a randomized controlled trial. [2022]

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

Musculoskeletal Therapies: Osteopathic Manipulative Treatment. [2018]

7. England pubmed.ncbi.nlm.nih.gov

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

8. Poland pubmed.ncbi.nlm.nih.gov

Application of osteopathic manipulative technique in the treatment of back pain during pregnancy. [2019]

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

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

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]