Chronic Low Back Pain and Osteopathic Manipulation Treatment

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

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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain; Chronic Low Back Pain (CLBP)
• Intervention / Treatment: Procedure: Usual VA Care; Procedure: Osteopathic manipulative treatment

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Phone Number: 708-202-2282; Email: TBD@va.gov

Study Locations

• United States
  • Illinois
    • Hines, Illinois, United States, 60141
      • Recruiting
      • Edward Hines, Jr. VA Hospital, PM&R Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual VA Care Group; 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.	Procedure: Usual VA Care; The usual treatment provided by PM&R clinicians for CLBP
Experimental: Usual VA Care + OMT Group; 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.	Procedure: Usual VA Care; The usual treatment provided by PM&R clinicians for CLBP; Procedure: Osteopathic manipulative treatment; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low-Back Pain Specific Pain Intensity	A numeric pain rating scale (NPRS) question adapted by the BACPAC to obtain pain rating for over last 7 days.	Baseline, 12 weeks, and 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain, Enjoyment, General Activity Scale (PEG)	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.	Baseline, 12 weeks, and 24 weeks
Brief Pain Inventory (BPI)	A 32-item questionnaire to assess pain history, interference, pain relief, pain quality, and perceived cause of pain.	Baseline, 12 weeks, and 24 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS)	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)	Baseline, 12 weeks, and 24 weeks
Patient Health Questionnaire (PHQ-2)	2-item questionnaire to screen for depression symptoms (frequency of depressed mood and anhedonia) during the past 2 weeks.	Baseline, 12 weeks, and 24 weeks
Generalized Anxiety Disorder 2-item (GAD-2)	A 2-item questionnaire to screen for generalized anxiety disorder, panic disorder, social anxiety disorder, and post-traumatic stress disorder.	Baseline, 12 weeks, and 24 weeks
Pain Catastrophizing Scale - Short Form 6 (PCS-6)	A 6-item measure to assess catastrophizing of pain.	Baseline, 12 weeks, and 24 weeks
Sleep Duration	A measure of duration to quantify the amount of sleep participants report, which is in addition to PROMIS Sleep Disturbance 6a.	Baseline, 12 weeks, and 24 weeks
Healthcare utilization cost	The number of treatment visits and medication use during study enrollment	Baseline, 12 weeks, and 24 weeks
Patients' Global Impression of Change (PGIC)	A 1-item questionnaire that measures perception of patients beliefs about the effectiveness of treatment.	Baseline, 12 weeks, and 24 weeks
Radicular Pain Questions	A 2-item measure adapted from NIH Research Task Force to capture radicular symptoms below the knee and/or thigh.	Baseline, 12 weeks, and 24 weeks
Abbreviated Pain Somatization	A 2-item measure that captures somatization of back pain as stomach pain and headaches.	Baseline, 12 weeks, and 24 weeks
Widespread Pain Inventory	A 1-item question to document areas of pain other than the low back.	Baseline, 12 weeks, and 24 weeks
Low Back Pain Duration and Frequency	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).	Baseline, 12 weeks, and 24 weeks
The Tobacco, Alcohol, Prescription medications, and other Substance Part 1 (TAPS1)	A 5- item questionnaire to identify unhealthy substance.	Baseline, 12 weeks, and 24 weeks
Alcohol Use Disorders Identification Test (AUDIT-C)	A 3-item alcohol screen that can help identify persons who are hazardous drinkers or have active alcohol use disorders.	Baseline, 12 weeks, and 24 weeks
Healing Encounters and Attitudes Lists (HEAL)	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.	Baseline, 12 weeks, and 24 weeks

Collaborators and Investigators

• Sponsor: Edward Hines Jr. VA Hospital
• Collaborators: Michigan State University

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: September 2, 2025
• First Submitted That Met QC Criteria: September 2, 2025
• First Posted (Actual): September 8, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Veterans; Osteopathic manipulation; Osteopathic manipulative treatment; Physical Medicine and Rehabilitation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Musculoskeletal Manipulations; Manipulation, Osteopathic
• Other Study ID Numbers: 1850064-1; Department of Defense (Other Grant/Funding Number: CP230185)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No