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NCT Number: NCT07161661

Chronic Low Back Pain and Osteopathic Manipulation Treatment

The goal of this clinical trial is to learn if adding Osteopathic Manipulative Therapy (OMT) to the usual medical care provided at the VA (usual VA care) improves treatment outcomes in individuals with chronic low back pain (CLBP). OMT is a set of hands-on techniques a doctor uses to move a patient's muscles and joints which include stretching, gentle pressure, resistance and applying forces to specific areas of the body. This feasibility clinical trial aims to learn about the treatment effects (e.g., effect sizes) of adding OMT to the usual medical care provided at the VA (Usual VA Care) in individuals with LBP.

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Key information

Conditions

Chronic Low Back Pain (CLBP) Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edward Hines, Jr. VA Hospital, PM&R Clinic

Hines, Illinois, 60141, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age and older
  • Seeking care for LBP from a participating VA clinic
  • Able to follow study protocol
  • Willing to be randomized to Usual VA Care or Usual VA Care + OMT
  • Individuals with pain primarily in the LBP region lasting > 3 months and present on at least half the days during the past 6 months
  • Pain rating over the past 7 days equal to or greater than 3/10 as indicated on the Numeric Rating Scale for Pain

Exclusion criteria

  • Signs of serious pathology as a cause of LBP
  • Underlying systemic or inflammatory conditions
  • Neurological diseases
  • Pregnancy
  • Previous back surgery or spinal fracture within the past year
  • Active workers' compensation or litigation for back pain
  • Any conditions impeding study protocol implementation or contraindication to OMT
  • No PM&R, OMT, chiropractic, or physical treatment where manual techniques are utilized within last 3mo

Treatment and study plan

Usual VA Care

Procedure

The usual treatment provided by PM&R clinicians for CLBP

Osteopathic Manipulative Treatment

Procedure

Between your first visit (baseline) and 12 weeks, participants will receive up to 4 usual care visits plus OMT.

Other names: Osteopathic Neuromuscular Manipulative Medicine

Primary outcomes

  1. Low-Back Pain Specific Pain Intensity

    Time frame: Baseline, 12 weeks, and 24 weeks

    A numeric pain rating scale (NPRS) question adapted by the BACPAC to obtain pain rating for over last 7 days.

Secondary outcomes

  1. Pain, Enjoyment, General Activity Scale (PEG)

    Time frame: Baseline, 12 weeks, and 24 weeks

    A 3-item measure to assess and to monitor different aspects of chronic pain. Originally intended to be used in a primary care setting, this instrument has been used as an outcome measure and recommended by NIH HEAL core outcome set.

  2. Brief Pain Inventory (BPI)

    Time frame: Baseline, 12 weeks, and 24 weeks

    A 32-item questionnaire to assess pain history, interference, pain relief, pain quality, and perceived cause of pain.

  3. Patient-Reported Outcomes Measurement Information System (PROMIS)

    Time frame: Baseline, 12 weeks, and 24 weeks

    PROMIS Depression Short Form 4a (4 item) , PROMIS Short Form Anxiety 4a (4 item), PROMIS Physical Functioning 6b (6 item), PROMIS Sleep Disturbance 6a (6 item), PROMIS Fatigue 4a (4 item)

  4. Patient Health Questionnaire (PHQ-2)

    Time frame: Baseline, 12 weeks, and 24 weeks

    2-item questionnaire to screen for depression symptoms (frequency of depressed mood and anhedonia) during the past 2 weeks.

  5. Generalized Anxiety Disorder 2-item (GAD-2)

    Time frame: Baseline, 12 weeks, and 24 weeks

    A 2-item questionnaire to screen for generalized anxiety disorder, panic disorder, social anxiety disorder, and post-traumatic stress disorder.

  6. Pain Catastrophizing Scale - Short Form 6 (PCS-6)

    Time frame: Baseline, 12 weeks, and 24 weeks

    A 6-item measure to assess catastrophizing of pain.

  7. Sleep Duration

    Time frame: Baseline, 12 weeks, and 24 weeks

    A measure of duration to quantify the amount of sleep participants report, which is in addition to PROMIS Sleep Disturbance 6a.

  8. Healthcare utilization cost

    Time frame: Baseline, 12 weeks, and 24 weeks

    The number of treatment visits and medication use during study enrollment

  9. Patients' Global Impression of Change (PGIC)

    Time frame: Baseline, 12 weeks, and 24 weeks

    A 1-item questionnaire that measures perception of patients beliefs about the effectiveness of treatment.

  10. Radicular Pain Questions

    Time frame: Baseline, 12 weeks, and 24 weeks

    A 2-item measure adapted from NIH Research Task Force to capture radicular symptoms below the knee and/or thigh.

  11. Abbreviated Pain Somatization

    Time frame: Baseline, 12 weeks, and 24 weeks

    A 2-item measure that captures somatization of back pain as stomach pain and headaches.

  12. Widespread Pain Inventory

    Time frame: Baseline, 12 weeks, and 24 weeks

    A 1-item question to document areas of pain other than the low back.

  13. Low Back Pain Duration and Frequency

    Time frame: Baseline, 12 weeks, and 24 weeks

    A 2-item measure to document CLBP as defined by NIH Task Force (back pain lasting greater than or equal to 3 months and having LBP at least half the days in the past 6 months).

  14. The Tobacco, Alcohol, Prescription medications, and other Substance Part 1 (TAPS1)

    Time frame: Baseline, 12 weeks, and 24 weeks

    A 5- item questionnaire to identify unhealthy substance.

  15. Alcohol Use Disorders Identification Test (AUDIT-C)

    Time frame: Baseline, 12 weeks, and 24 weeks

    A 3-item alcohol screen that can help identify persons who are hazardous drinkers or have active alcohol use disorders.

  16. Healing Encounters and Attitudes Lists (HEAL)

    Time frame: Baseline, 12 weeks, and 24 weeks

    A 39-item questionnaire to capture Patient-Provider Connection, Healthcare Environment, Treatment Expectancy, Positive Outlook, Spirituality, and Attitudes toward Complementary and Alternative Medicine (CAM)/CIH approaches.

Study contacts

Contact information is provided by the study sponsor or research team.

CONTACT

[email protected]

708-202-2282

Sponsors and collaborators

Lead sponsor

Edward Hines Jr. VA Hospital

Fed

Collaborators

  • Michigan State University

Registry information

Official study title

Feasibility of Implementing Manual Medicine in the Multimodal Management of Veterans and Service Members With Chronic Low Back Pain

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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