Chronic Low Back Pain (CLBP)NCT07161661
Chronic Low Back Pain and Osteopathic Manipulation Treatment
A study testing Usual VA Care and Osteopathic manipulative treatment in people with Chronic Low Back Pain (CLBP) and Low Back Pain, run by Edward Hines Jr. VA Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain (CLBP), Low Back Pain
- What is being tested?
- Usual VA Care and Osteopathic manipulative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Edward Hines, Jr. VA Hospital, PM&R Clinic
Hines, Illinois, 60141
About this study
Official title: 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.
- Conditions
- Chronic Low Back Pain (CLBP), Low Back Pain
- Being tested
- Usual VA Care, Osteopathic manipulative treatment
- Keywords
- Osteopathic manipulative treatment, Physical Medicine and Rehabilitation, Veterans, Osteopathic manipulation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual VA CareProcedure or surgery
The usual treatment provided by PM\&R clinicians for CLBP
Osteopathic manipulative treatmentProcedure or surgery
Also called Osteopathic Neuromuscular Manipulative Medicine
Between your first visit (baseline) and 12 weeks, participants will receive up to 4 usual care visits plus OMT.
| Study group | Role | What they receive |
|---|---|---|
| Usual VA Care Group | Active comparator | 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. Receives: Procedure: Usual VA Care |
| Usual VA Care + OMT Group | Experimental | 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. Receives: Procedure: Usual VA Care; Procedure: Osteopathic manipulative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12 weeks, and 24 weeks
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Baseline, 12 weeks, and 24 weeks
Pain Catastrophizing Scale - Short Form 6 (PCS-6)
A 6-item measure to assess catastrophizing of pain.
Measured: 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.
Measured: Baseline, 12 weeks, and 24 weeks
Healthcare utilization cost
The number of treatment visits and medication use during study enrollment
Measured: 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.
Measured: 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.
Measured: Baseline, 12 weeks, and 24 weeks
Abbreviated Pain Somatization
A 2-item measure that captures somatization of back pain as stomach pain and headaches.
Measured: Baseline, 12 weeks, and 24 weeks
Widespread Pain Inventory
A 1-item question to document areas of pain other than the low back.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 12 weeks, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start2 Mar 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edward Hines Jr. VA Hospital
- Sponsor type
- US federal agency
- Collaborators
- Michigan State University
- Responsible party
- Principal investigator, Clarence Nicodemus, Edward Hines Jr. VA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161661
- Sponsor's protocol ID
- 1850064-1
- Other IDs
- Department of Defense
- Status last verified
- May 2026
- First submitted
- 2 Sep 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Implementing Manual Medicine in the Multimodal Management of Veterans and Service Members With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07161661
- Acronym / sponsor ID
- 1850064-1
- Conditions
- Chronic Low Back Pain (CLBP), Low Back Pain
- Keywords
- Osteopathic manipulative treatment, Physical Medicine and Rehabilitation, Veterans, Osteopathic manipulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Edward Hines Jr. VA HospitalUS federal agency
- Collaborators
- Michigan State University
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual VA Care Group | Active comparator | Procedure: Usual VA CareAll 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. |
| Usual VA Care + OMT Group | Experimental | Procedure: Usual VA Care, Procedure: Osteopathic manipulative treatmentParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual VA CareThe usual treatment provided by PM\&R clinicians for CLBP | Procedure or surgery | Usual VA Care + OMT Group, Usual VA Care Group |
| Osteopathic manipulative treatmentAlso: Osteopathic Neuromuscular Manipulative MedicineBetween your first visit (baseline) and 12 weeks, participants will receive up to 4 usual care visits plus OMT. | Procedure or surgery | Usual VA Care + OMT Group |
Primary outcome
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.
16 secondary outcomes
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
Low Back Pain Duration and Frequency
Time frame: Baseline, 12 weeks, and 24 weeks
The Tobacco, Alcohol, Prescription medications, and other Substance Part 1 (TAPS1)
Time frame: Baseline, 12 weeks, and 24 weeks
Alcohol Use Disorders Identification Test (AUDIT-C)
Time frame: Baseline, 12 weeks, and 24 weeks
Healing Encounters and Attitudes Lists (HEAL)
Time frame: Baseline, 12 weeks, and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual VA Care and Osteopathic manipulative treatment in people with Chronic Low Back Pain (CLBP) and Low Back Pain, run by Edward Hines Jr. VA Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact the study contact (708-202-2282, TBD@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low-Back Pain Specific Pain Intensity (time frame: Baseline, 12 weeks, and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.