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Recruiting NCT07161661

Chronic Low Back Pain and Osteopathic Manipulation Treatment

No phase Interventional Chronic Low Back Pain (CLBP) Low Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Usual VA Care, Osteopathic manipulative treatment.
Who it may be relevant to
Registry conditions: Chronic Low Back Pain (CLBP), Low Back Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Low-Back Pain Specific Pain Intensity [Time frame: Baseline, 12 weeks, and 24 weeks]
Secondary outcome measures (12)
  • Pain, Enjoyment, General Activity Scale (PEG) [Time frame: Baseline, 12 weeks, and 24 weeks]
  • Brief Pain Inventory (BPI) [Time frame: Baseline, 12 weeks, and 24 weeks]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) [Time frame: Baseline, 12 weeks, and 24 weeks]
  • Patient Health Questionnaire (PHQ-2) [Time frame: Baseline, 12 weeks, and 24 weeks]
  • Generalized Anxiety Disorder 2-item (GAD-2) [Time frame: Baseline, 12 weeks, and 24 weeks]
  • Pain Catastrophizing Scale - Short Form 6 (PCS-6) [Time frame: Baseline, 12 weeks, and 24 weeks]
  • Sleep Duration [Time frame: Baseline, 12 weeks, and 24 weeks]
  • Healthcare utilization cost [Time frame: Baseline, 12 weeks, and 24 weeks]
  • Patients' Global Impression of Change (PGIC) [Time frame: Baseline, 12 weeks, and 24 weeks]
  • Radicular Pain Questions [Time frame: Baseline, 12 weeks, and 24 weeks]
  • Abbreviated Pain Somatization [Time frame: Baseline, 12 weeks, and 24 weeks]
  • Widespread Pain Inventory [Time frame: Baseline, 12 weeks, and 24 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Edward Hines, Jr. VA Hospital, PM&R Clinic — Hines

Identifiers

NCT: NCT07161661 · 1850064-1 · Department of Defense

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗