Chronic Low Back Pain and Osteopathic Manipulation Treatment

Not Applicable

Recruiting

• Conditions: Chronic Low Back Pain (CLBP); Low Back Pain

• Registration Number: NCT07161661
• Lead Sponsor: Edward Hines Jr. VA Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-09-02
• Study First Submitted QC: 2025-09-02
• Study First Posted: 2025-09-08
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-08
• Last Update Posted: 2025-10-09
• Study Start: 2025-11-01
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Low-Back Pain Specific Pain Intensity	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 Outcome Measures

Name	Time	Method
Pain Catastrophizing Scale - Short Form 6 (PCS-6)	Baseline, 12 weeks, and 24 weeks	A 6-item measure to assess catastrophizing of pain.
Sleep Duration	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.
Radicular Pain Questions	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.
Abbreviated Pain Somatization	Baseline, 12 weeks, and 24 weeks	A 2-item measure that captures somatization of back pain as stomach pain and headaches.
Widespread Pain Inventory	Baseline, 12 weeks, and 24 weeks	A 1-item question to document areas of pain other than the low back.
Low Back Pain Duration and Frequency	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).
The Tobacco, Alcohol, Prescription medications, and other Substance Part 1 (TAPS1)	Baseline, 12 weeks, and 24 weeks	A 5- item questionnaire to identify unhealthy substance.
Alcohol Use Disorders Identification Test (AUDIT-C)	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.
Healing Encounters and Attitudes Lists (HEAL)	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.
Patients' Global Impression of Change (PGIC)	Baseline, 12 weeks, and 24 weeks	A 1-item questionnaire that measures perception of patients beliefs about the effectiveness of treatment.
Pain, Enjoyment, General Activity Scale (PEG)	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.
Patient-Reported Outcomes Measurement Information System (PROMIS)	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)
Patient Health Questionnaire (PHQ-2)	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.
Healthcare utilization cost	Baseline, 12 weeks, and 24 weeks	The number of treatment visits and medication use during study enrollment
Generalized Anxiety Disorder 2-item (GAD-2)	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.
Brief Pain Inventory (BPI)	Baseline, 12 weeks, and 24 weeks	A 32-item questionnaire to assess pain history, interference, pain relief, pain quality, and perceived cause of pain.

Trial Locations

Locations (1)

Edward Hines, Jr. VA Hospital, PM&R Clinic; 🇺🇸 Hines, Illinois, United States